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1

Grimes, Warren. "Perverse Results from Pharmaceutical Patents in the United States." IIC - International Review of Intellectual Property and Competition Law 52, no. 5 (2021): 596–605. http://dx.doi.org/10.1007/s40319-021-01055-9.

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AbstractIn the United States, pharmaceutical patents have had a number of perverse and anticompetitive effects on the development and marketing of prescription drugs. Although some of these effects are unique to the United States, others have implications for patent policy across the world. Among the negative effects of drug patents are: (1) examples of misguided, anti-social, and anticompetitive promotion of patented drugs; (2) misguided incentives that push drug firms toward too much or too little research and development in critical areas: and (3) cartel-facilitating conduct linked to patent licenses or settlements of litigation involving drug patents. Some of these issues can be addressed directly through reforms in patent and competition law policy. There is, however, a need for a broader study of the role of patents in promoting drug research. That study should consider alternatives to the patent system, such as a prize system structured to supplement or partially replace patent rewards for pharmaceutical R&D.
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2

Liu, Li, and Hongzhou Lu. "Technology Development Through Pooling ARV Drug Patents: A Vision from China." Open AIDS Journal 4, no. 1 (2010): 54–59. http://dx.doi.org/10.2174/1874613601004020054.

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Unaffordable prices still bar the end-users in China from accessing ARV drugs. Patent protection of ARV drugs has dramatically limited the availability of these lifesaving drugs to AIDS patients in China. The way Chinese government can go to breakthrough the ARV drug patents are suggested as: - Make more generic drugs available through compulsory licensing, impartment from other countries or building ARVs plants by partnerships between governments or generic drug companies. - Do a thorough and detailed research on the patent application of ARV drugs to find out the loophole. - Try patent pool to make AIDS medicines more affordable and appropriate for patients.
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3

Anaya-Ruiz, Maricruz, Cindy Bandala, Gerardo Landeta, et al. "Nanostructured Systems in Advanced Drug Targeting for the Cancer Treatment: Recent Patents." Recent Patents on Anti-Cancer Drug Discovery 14, no. 1 (2019): 85–94. http://dx.doi.org/10.2174/1574892813666181031154146.

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Background: Cancer is one of the leading causes of death in the world and it is necessary to develop new strategies for its treatment because most therapies have limited access to many types of tumors, as well as low therapeutic efficacy and high toxicity.Objective:The present research aims to identify recent patents of drug delivery nanostructured systems that may have application in improving cancer treatment.Methods:Recent patents regarding the drug delivery nanostructured systems for cancer treatment were obtained from the patent databases of the six main patent offices of the world: United States Patent and Trademark Office, European Patent Office, World Intellectual Property Organization, Japan Patent Office, State Intellectual Property Office of China and Korean Intellectual Property Office.Results:A total of 1710 patent documents from 1998 to 2017 including "drug delivery nanostructured systems for cancer treatment" were retrieved. The top five countries in patent share were USA, China, South Korea, Canada and Germany. The universities and enterprises of USA had the highest amount of patents followed by institutions from China.Conclusion:There is a strong tendency for the development of new nanostructured systems for the release of drugs; particularly, in recent years, the development of nanoparticles has focused on nanodiscs, gold nanoparticles and immunoliposomes.
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4

Wang, Ling, Xu Zhi, Haokun Ke, et al. "Global patent statistical analysis for drug testing technology." Technology and Health Care 29 (March 25, 2021): 415–25. http://dx.doi.org/10.3233/thc-218039.

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BACKGROUND: In recent decades, illicit drug testing has become a high priority area in law enforcement and forensic analysis. OBJECTIVE: Since patents are the largest source of technical information in the world, patent database analysis for illicit drug testing is extremely important to effectively promote the development and protection of the related intellectual property rights. METHODS: In the present study, we first retrieve a database of 1732 drug detection patents using keywords and logical expressions related to the title, abstract, and claims, and subsequently discuss the current global patent statistics in detail. RESULTS: The relevant patent information is presented, including patent application quantity, filing country, ownership, and technical field. CONCLUSIONS: Finally, we summarize the current development trend in drug testing and propose several suggestions focused on the bottleneck of analytical techniques.
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5

Gharge, Vikram S., Mukesh B. Shinde, Bipin D. Pustake, Krishna B. Kinage, and Anup A. Kulkarni. "Nanosuspensions: Recent Patents and Pharmaceutical Aspects as Drug Delivery Systems." International Journal of Pharmaceutical Sciences and Nanotechnology 10, no. 2 (2017): 3631–44. http://dx.doi.org/10.37285/ijpsn.2017.10.2.1.

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Solubility is an essential factor for drug effectiveness, independent of the route of administration. Poorly soluble drugs are often a challenging task for formulators in the industry. Conventional approaches for enhancement of solubility have limited applicability, especially when the drugs are poorly soluble simultaneously in aqueous and in non-aqueous media. Nanosuspension technology can be used to improve the stability as well as the bioavailability of poorly soluble drugs. Nanosuspensions are biphasic systems consisting of pure drug particles dispersed in an aqueous vehicle, stabilized by surfactants. These are simple to prepare and are more advantageous than other approaches. Techniques such as wet milling, high-pressure homogenization, emulsification–solvent evaporation and super critical fluid have been used in the preparation of nanosuspensions. It has the advantage of delivery by various routes, including oral, parenteral, pulmonary and ocular routes. The present article reviews the current methods used to prepare nanosuspensions and their application in drug delivery. More than 100 patents have been published on nanosuspensions in the recent days. This patent reviews covers different methods of pharmaceutical preparation and applications in drug delivery as well as the recent marketed published or granted patent surveys. This patent review is useful in enhanceing the knowledge of pharmaceutical application in drug delivery.
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6

Abbas, Muhammad Z. "Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 15, no. 2 (2019): 53–60. http://dx.doi.org/10.1177/1741134319848797.

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Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system – namely the ‘natural law’ or ‘natural rights’ theory, the ‘reward by monopoly’ theory, the ‘monopoly-profit incentive’ theory, the ‘exchange for secrets’ theory or the ‘contract’ theory, and the ‘prospect’ theory – to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification.
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7

Singh, Ruchita, Charles Brumlik, Mandar Vaidya, and Abhishek Choudhury. "A Patent Review on Nanotechnology-Based Nose-to-Brain Drug Delivery." Recent Patents on Nanotechnology 14, no. 3 (2020): 174–92. http://dx.doi.org/10.2174/1872210514666200508121050.

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Background: Current cerebral drug delivery to the brain and Cerebrospinal Fluid (CSF) is limited by the Blood-Brain Barrier (BBB) or the blood-blood Cerebrospinal Fluid (CSF) barrier. The popular, non-invasive, intranasal delivery provides an exciting route for topical and systemic applications. For example, intranasal drug delivery of Central Nervous System (CNS) drugs can be designed to pass the BBB barrier via the nose-to-brain pathways. Recent nanotechnology research and patenting focus mainly on overcoming typical limitations including bioavailability, transport, BBB penetration, targeted delivery, controlled release rate and controlled degradation. Objective: The aim of the present study was to assess the state-of-the-art of nose-to-brain drug delivery systems and the role of nanotechnology in targeted delivery for the treatment of CNS and related therapeutic conditions. Methods: Patent and related searches were made with analytics to explore and organize nanotech work in intranasal drug delivery to the brain. Technical advancements were mapped by API, formulation and performance criteria. Patents and published patent applications were searched with concept tables of keywords, metadata (e.g., assignee) and patent classes (e.g., International Patent Classes and Cooperative Patent Classes). Results: The reviewed patents and published applications show a focus on formulations and therapeutic indications related to the nano-based nose-to-brain drug delivery. The main patented materials were surface modifiers, delivery systems and excipients. Conclusion: Surface modified nanoparticles can greatly improve drug transport and bioavailability of drugs, particularly higher molecular weight drugs. The most commonly used surface modifiers were chitosan, lectin and cyclodextrin-cross-linker complex. Nanoformulations of herbal drugs could increase drug bioavailability and reduce toxicity. Biotechnology-related drug delivery approaches such as monoclonal antibodies and genetically engineered proteins (molecular Trojan horses) deliver large molecule therapeutics.
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8

Phelps, Charles E. "Extending Exclusivity for Biopharmaceuticals to Deter Competing Generics: A Review of Strategies, Potential Mitigation, and Similarities to Infringement." Technology & Innovation 21, no. 3 (2020): 215–27. http://dx.doi.org/10.21300/21.3.2020.215.

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Some patents confront infringement—unauthorized use of the inventions in the patent—thus violating the exclusive use intent of the U.S. Constitution's creation of the patent system to encourage innovation. In other situations, the reverse occurs—patent holders seek to extend their exclusivity period to prevent competitive entrants. This commonly occurs in biopharmaceutical products markets, where annual revenues on many patented drugs exceed $1 billion per year and (most importantly) where several pathways allow extension of exclusivity. This paper reviews the relevant legislation (Bayh-Dole Act, Orphan Drug Act, Hatch-Waxman Act, and Food and Drug Administration (FDA) Modernization Act) as well as the safety and efficacy regulations of the FDA that control marketing of biopharmaceutical products. The paper then assesses methods used to extend patent exclusivity—some legal, some clearly illegal, and some with ambiguous legal status—in order to deter generic entrants. These methods include using FDA "citizen's petitions," creating generic equivalents of branded drugs to block other generic entrants, deterring potential generic competitors from gaining samples to prove bioequivalence to original formulations, seeking additional patents to extend exclusivity (sometimes for trivial changes), paying potential entrants to delay entry, subdividing the potential patient population to qualify for extensions granted by "orphan drug" status, and (most recently) selling patents to Native American tribes to prevent challenges to their validity. The paper concludes by discussing remedies—primarily legislative—that could either eliminate these actions and/or clarify their legality. Then follows a comparison between these entry-delaying strategies and patent infringement itself.
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9

CONTRACTOR, SUNIL H., PIYUSH KUMAR, and THOMAS W. LEIGH. "THE IMPACT OF GOVERNANCE MECHANISMS ON ESCALATION OF COMMITMENT." International Journal of Innovation Management 16, no. 04 (2012): 1250023. http://dx.doi.org/10.1142/s1363919612500235.

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There are conflicting opinions on whether the existing US legal and economic environment for pharmaceutical research is conducive for the repurposing of patent-protected drugs. This article therefore addresses the following innovation policy questions: Does US patent law and regulatory policy assign sufficient value to new use patents in the pharmaceutical industry? If present law and regulatory policy does assign sufficient value, what evidence is there that the pharmaceutical industry is actively involved in technology strategies to repurpose existing pharmaceuticals? Based on an evaluation of the extant legal literature, US pharmaceutical firms are generally successful at legally enforcing their new use patents against infringement. Furthermore, the truncating of the time and resources dedicated to the drug discovery, development, and regulatory review process provide sufficient economic "value" on both the front end of the pharmaceutical regulatory approval process, and the back end of the drug patent term for encouraging pharmaceutical industry repurposing.
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10

Sachs, Rachel. "The Uneasy Case for Patent Law." Michigan Law Review, no. 117.3 (2018): 499. http://dx.doi.org/10.36644/mlr.117.3.uneasy.

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A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights. This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of the role of patents in the emerging field of microbiome research. Scientists have recently begun to appreciate the important role played by the human microbiome, the community of microbes that lives within each of our bodies, in preventing and treating disease. The microbiome has been linked to autoimmune disorders, mental health conditions, and a range of conditions affecting our intestinal systems. Put simply, research involving the microbiome has the potential to change the future of medicine. There’s just one problem: the microbiome can’t meaningfully be patented. Several doctrines within patent law will make it extremely difficult for companies to obtain and enforce patents like the ones that are so readily available in most areas of medicine. Drawing on patent doctrine, patent searches, and interviews with scientists and lawyers, this Article demonstrates that companies are developing microbiome-based therapies largely in the absence of patent protection. Instead, the companies are relying on other innovation incentives to fill the gap. The microbiome’s unpatentability presents an opportunity to evaluate whether patents are truly necessary for the development of new drugs. Congress, the NIH, and the FDA have implemented many innovation incentives throughout the development process, and we should not be astonished that removing a single such incentive, patent law, does not disrupt the entire system. Perhaps scholars should reconsider, if only selectively, our focus on patents as an irreplaceable driver of pharmaceutical innovation.
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11

Meirelles, Lyghia Maria Araújo, and Fernanda Nervo Raffin. "Clay and Polymer-Based Composites Applied to Drug Release: A Scientific and Technological Prospection." Journal of Pharmacy & Pharmaceutical Sciences 20 (May 19, 2017): 115. http://dx.doi.org/10.18433/j3r617.

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There has been a growing trend in recent years for the development of hybrid materials, called composites, based on clay and polymers, whose innovative properties render them attractive for drug release. The objective of this manuscript was to conduct a review of original articles on this topic published over the last decade and of the body of patents related to these carriers. A scientific prospection was carried out spanning the period from 2005 to 2015 on the Web of Science database. The technological prospection encompassed the United States Patent and Trademark Office, the European Patent Office, the World International Patent Office and the National Institute of Industrial Property databases, filtering patents with the code A61K. The survey revealed a rise in the number of publications over the past decade, confirming the potential of these hybrids for use in pharmaceutical technology. Through interaction between polymer and clay, the mechanical and thermal properties of composites are enhanced, promoting stable, controlled drugs release in biological media. The most cited clays analyzed in the articles was montmorillonite, owing to its high surface area and capacity for ion exchange. The polymeric part is commonly obtained by copolymerization, particularly using acrylate derivatives. The hybrid materials are obtained mainly in particulate form on a nanometric scale, attaining a modified release profile often sensitive to stimuli in the media. A low number of patents related to the topic were found. The World International Patent Office had the highest number of lodged patents, while Japan was the country which published the most patents. A need to broaden the application of this technology to include more therapeutic classes was identified. Moreover, the absence of regulation of nanomaterials might explain the disparity between scientific and technological output. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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12

Akhtar, Naseem, Salman AA Mohammed, Varsha Singh, et al. "Liposome-based drug delivery of various anticancer agents of synthetic and natural product origin: a patent overview." Pharmaceutical Patent Analyst 9, no. 3 (2020): 87–116. http://dx.doi.org/10.4155/ppa-2019-0020.

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Phospholipid-based liposomal vesicles are among the most effective delivery options currently available for various classes of anticancer drugs. The patents granted to inventions disclosing details on liposomal delivery module by the US Patent and Trademark Office, European Patent Office, and world patent holdings through WIPO (World Intellectual Property Organization) patenting have been sorted based upon liposome, and anticancer keywords within the abstract and claims sections of the patents for the period between 2000 and 2019, thereby disclosing novel liposome formulations encapsulating single, or combination of chemotherapeutic agents that have been far more chemically and physiologically stable, therapeutically efficacious, and comparatively less toxic than their nonliposomal free-drug counterparts. The added stability, site-specific transport, and payload delivery, enhanced bioavailability, fast body clearance, and biocompatibility together with the controlled and sustained delivery-related benefits claimed in the patent literature have been exclusively discussed with a focus on the last 5-year period.
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13

GABRIEL, JOSEPH M. "Pharmaceutical patenting and the transformation of American medical ethics." British Journal for the History of Science 49, no. 4 (2016): 577–600. http://dx.doi.org/10.1017/s0007087416001138.

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AbstractThe attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians.
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14

Iqbal, Zeenat, and Fahima Dilnawaz. "Nanocarriers For Vaginal Drug Delivery." Recent Patents on Drug Delivery & Formulation 13, no. 1 (2019): 3–15. http://dx.doi.org/10.2174/1872211313666190215141507.

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Background:Vaginal drug delivery approach represents one of the imperative strategies for local and systemic delivery of drugs. The peculiar dense vascular networks, mucus permeability, and range of physiological characteristics of the vaginal cavity have been exploited for therapeutic benefit. Furthermore, the vaginal drug delivery has been curtailed due to the influence of different physiological factors like acidic pH, constant cervical secretion, microflora, cyclic changes during periods along with turnover of mucus of varying thickness.Objective:This review highlights advancement of nanomedicine and its prospective progress towards the clinic.Methods:Relevant literature reports and patents related to topics are retrieved and used. Result: The extensive literature search and patent revealed that nanocarriers are efficacious over conventional treatment approaches.Results:The extensive literature search and patent revealed that nanocarriers are efficacious over conventional treatment approaches.Conclusion:Recently, nanotechnology based drug delivery approach has promised better therapeutic outcomes by providing enhanced permeation and sustained drug release activity. Different nanoplatforms based on drugs, peptides, proteins, antigens, hormones, nucleic material, and microbicides are gaining momentum for vaginal therapeutics.
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15

Okada, Yoshimi, and Sadao Nagaoka. "Global Spread of Pharmaceutical Patent Protection: Micro Evidence from the International Equivalents of Drug Patents in Japan." Millennial Asia 8, no. 1 (2017): 26–47. http://dx.doi.org/10.1177/0976399616686864.

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We investigate the global spread of pharmaceutical patent protection as acquired by firms, based on a novel global patent database for all significant medical drugs, including biologics, introduced in Japan. It gives us the propensity of filing and grant rate for each country for patents granted in Japan. The major findings of the study are as following. Both the filing propensity to and the grant rate of major Asian countries approached those of the OECD economies by the early 2000s for chemical substance inventions. However, substantial heterogeneity with respect to other drug inventions still exists, specifically, crystal, use, formulation or combination, suggesting significant future room for international harmonization of patent granting standards. We found clear evidence of policy impact on the spread of protection for the two largest non-OECD economies. The amendments to Patent Laws in China in 1993 had an immediate and significant impact on patent filing propensity to China (30 percentage points increase), before accession to the WTO in late 2001. Furthermore, India’s ‘mailbox application system’ had a substantial effect as filing propensity reached 80 per cent of the number of corresponding European patent applications around year 2000, prior to implementing the Trade-Related Aspects of Intellectual Property Rights for drug patents in 2005. Subject classification codes: O34, O38, K29
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Kreutz, Tainá, Sheila Porto de Matos, and Letícia Scherer Koester. "Recent Patents on Permeation Enhancers for Drug Delivery Through Nails." Recent Patents on Drug Delivery & Formulation 13, no. 3 (2020): 203–18. http://dx.doi.org/10.2174/1872211313666191030155837.

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: The human nail is a unique barrier with a keratinized constitution that favors protection and fine touch. However, many disorders can affect the nail, among them, are the onychomycosis and psoriasis. Systemic oral therapy has been applied to treat these diseases, even presenting disadvantages, including side effects, drug interactions, contraindications, toxicity, high cost and low patient compliance. A great option to succeed in dealing with the problems associated with oral therapy is the topical administration of drugs. However, nail composition, low diffusion through ungual route and reduced tissue bioavailability for topical treatments are limiting factors. These drawbacks can be overcome by promoting penetration through the nails by employing penetration enhancers. The review focuses on patents that highlight permeation enhancers applied to nail drug delivery for the treatment of onychomycosis and psoriasis. Literature and patent searches were conduced regarding the topic of interest. The substantial literature and patent search revealed that permeation enhancers, especially chemicals, are great strategies for promoting the ungual delivery of drugs. Nail topical therapy containing permeation enhancers is an attractive option for delivering localized treatments.
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17

Pineda, Bismarck. "Drug Patents In Guatemala." Health Affairs 29, no. 3 (2010): 566. http://dx.doi.org/10.1377/hlthaff.2010.0139.

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18

Rosina, Mônica Steffen Guise, and Lea Shaver. "Why are Generic Drugs Being Held up in Transit? Intellectual Property Rights, International Trade, and the Right to Health in Brazil and beyond." Journal of Law, Medicine & Ethics 40, no. 2 (2012): 197–205. http://dx.doi.org/10.1111/j.1748-720x.2012.00658.x.

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Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have witnessed more than 100-fold price reduction for antiretroviral (ARV) drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world.
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19

Kiran, Saritha, Sivakami Dhulap, and Mohan Kulkarni. "Secondary patents: innovator and generic strategies." Pharmaceutical Patent Analyst 8, no. 5 (2019): 175–91. http://dx.doi.org/10.4155/ppa-2019-0016.

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The global pharmaceutical industry consists of innovators and generics. Innovators focus on drug discovery, and bring new drugs into the marketplace after filing the new drug applications. In contrast, the generics enter the market by making a bioequivalent product by filing abbreviated new drug applications. In order to maximize their returns on R&D and maintain market share, the innovators introduce a wide range of drug products based on the same ‘new molecular entity’ and protect them against competition by filing what the industry term as secondary patents. The patents of four innovator viz., AstraZeneca, Takeda, Eisai and Wyeth related to the gastroesophageal reflux disease drugs and how their new molecular entity patents overcame the nonobviousness criteria is analyzed and studied in detail.
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20

Iqbal, Zarina, and Saima Sadaf. "Sitagliptin (Januvia) patent litigation: Another link in the judicial train of ‘Proactive Infringement’ of patented rights in developing countries." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 16, no. 2 (2020): 64–71. http://dx.doi.org/10.1177/1741134320912776.

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Driven by increasing instances of successful ‘at-risk’ launch of patented drugs in America and Europe, the strategy of using ‘proactive infringement’ as a legal tool is now getting-in, in developing countries. The rationale behind launch-at-risk is to counterbalance the innovator companies’ strategies of getting the patented product life extended through protecting improvement innovations and maintain market exclusivity even after the expiration of the compound patent. The battle for market and drive for higher profits between generics and innovator drug companies has extended the application of at-risk launch of the generic drugs even when compound patent is still running. Sitagliptin (Januvia) may be ranked at top of the drugs that have been fiercely litigated in the developing countries during their patent term. This article reviews the outcome of sitagliptin patent litigation and impact on the market exclusivity in some developing countries. This takes the position that the existing conflict between the innovators and generics can be resolved by diluting the misconception that patents on improvement innovations are misuse of patent system or inappropriate extension of patented product life on the part of innovator companies. Whether trivial, simplified or complex, if novel and non-obvious, further improvements in the precursor drugs are patentable within the legal framework of the patent system. The real issue is the scope of monopoly granted to the secondary or follow-on patents. Once the compound patent has expired, follow-on patents on improvements relating to the same compound should not be allowed to use as legal-barrier for the generic medicines entry to the market.
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Sousa, Liliana B., Paulo Santos-Costa, Inês A. Marques, Arménio Cruz, Anabela Salgueiro-Oliveira, and Pedro Parreira. "Brief Report on Double-Chamber Syringes Patents and Implications for Infusion Therapy Safety and Efficiency." International Journal of Environmental Research and Public Health 17, no. 21 (2020): 8209. http://dx.doi.org/10.3390/ijerph17218209.

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This review aimed to map the existing patents of double-chamber syringes that can be used for intravenous drug administration and catheter flush. A search was conducted in the Google patents database for records published prior to 28 October 2020, using several search terms related to double-chamber syringes (DCS). Study eligibility and data extraction were performed by two independent reviewers. Of the initial 26,110 patents found, 24 were included in this review. The 24 DCS that were found display two or more independent chambers that allow for the administration of multiple solutions. While some of the DCS have designated one of the chambers as the flushing chamber, most patents only allow for the sequential use of the flushing chamber after intravenous drug administration. Most DCS were developed for drug reconstitution, usually with a freeze-dried drug in one chamber. Some patents were designed for safety purposes, with a parallel post-injection safety sheath chamber for enclosing a sharpened needle tip. None of the DCS found allow for a pre- and post-intravenous drug administration flush. Given the current standards of care in infusion therapy, future devices must allow for the sequential use of the flushing chamber to promote a pre-administration patency assessment and a post-administration device flush.
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22

MULLIN, RICK. "WTO DRUG PACT BYPASSES PATENTS." Chemical & Engineering News 81, no. 36 (2003): 14. http://dx.doi.org/10.1021/cen-v081n036.p014.

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23

WEBBER, DAVID. "Drug firms dominate biotechnology patents." Chemical & Engineering News 64, no. 8 (1986): 17. http://dx.doi.org/10.1021/cen-v064n008.p017.

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24

Collier, R. "Drug patents: innovation v. accessibility." Canadian Medical Association Journal 185, no. 9 (2013): E379—E380. http://dx.doi.org/10.1503/cmaj.109-4465.

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Collier, R. "Drug patents: the evergreening problem." Canadian Medical Association Journal 185, no. 9 (2013): E385—E386. http://dx.doi.org/10.1503/cmaj.109-4466.

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26

Love, James. "Drug Patents In Poor Countries." Health Affairs 23, no. 5 (2004): 279. http://dx.doi.org/10.1377/hlthaff.23.5.279.

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27

Mogee, Mary Ellen, and Richard G. Kolar. "Patent citation analysis of Allergan pharmaceutical patents." Expert Opinion on Therapeutic Patents 8, no. 10 (1998): 1323–46. http://dx.doi.org/10.1517/13543776.8.10.1323.

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28

Falaguera, Maria, and Jordi Mestres. "Congenericity of Claimed Compounds in Patent Applications." Molecules 26, no. 17 (2021): 5253. http://dx.doi.org/10.3390/molecules26175253.

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A method is presented to analyze quantitatively the degree of congenericity of claimed compounds in patent applications. The approach successfully differentiates patents exemplified with highly congeneric compounds of a structurally compact and well defined chemical series from patents containing a more diverse set of compounds around a more vaguely described patent claim. An application to 750 common patents available in SureChEMBL, SureChEMBLccs and ChEMBL is presented and the congenericity of patent compounds in those different sources discussed.
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29

Targhotra, Monika, and Meenakshi K. Chauhan. "An Overview on Various Approaches and Recent Patents on Buccal Drug Delivery Systems." Current Pharmaceutical Design 26, no. 39 (2020): 5030–39. http://dx.doi.org/10.2174/1381612826666200614182013.

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Background: Buccal delivery is an alluring course of organization for fundamental medication conveyance and it leads direct access to the systemic flow through the interior jugular vein sidesteps drugs from the hepatic first-pass digestion gives high bioavailability. Objective: This article aims at buccal medication conveyance by discussing the structure and condition of the oral mucosa and the novel strategies utilized in evaluating buccal medication ingestion. Methods: This review highlights the various pharmaceutical approaches for buccal delivery such as buccal tablets, buccal lozenges, buccal micro/nanoparticle, wafer and semisolid dosage forms like chewing gums, buccal patch, buccal gel or ointment and some buccal liquid dosage forms like buccal solutions and buccal sprays and recent patents filed or granted for these approaches. Results: Recently, some patents are also reported where a combination of various approaches is being employed to achieve very effective mucosal delivery. The various patent search sites were used to collect and analyze the information on buccal drug delivery systems. Conclusion: The present study provides valuable information, advantages, limitations and future outlook of various buccal drug delivery systems.
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Vora, Pratik A., Rakesh Patel, and Abhay Dharamsi. "Bortezomib – First Therapeutic Proteasome Inhibitor for Cancer Therapy: A Review of Patent Literature." Recent Patents on Anti-Cancer Drug Discovery 15, no. 2 (2020): 113–31. http://dx.doi.org/10.2174/1574892815666200401113805.

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Background: Bortezomib is a reversible inhibitor of proteasome proteins in mammalian cells. Bortezomib is proven to be cytotoxic to a number of tumor cells by disrupting their normal homeostatic mechanism and thereby, causing cell death. Currently, Bortezomib is prescribed for patients with multiple myeloma and mantle cell lymphoma. Objective: This assessment highlights the overview of the recent patents of Bortezomib. This review includes patents grouped in sections like product patents, process patent, composition related patents as well as the treatment methodology. The objective of this article is to facilitate researchers with all existing patents at a single place. Methods: Data were searched from various online databases. In which, paid databases include SciFinder® and Orbit®. Free databases include Patentscope® (WIPO), Worldwide Espacenet® (EPO), Google Patents and InPASS (Indian patent database). Results: Several new processes and composition related patents of Bortezomib have been recently patented as its orange-book listed patents are going to soon expire during July 2022. Further, due to the problem of oxidation during development and long-term storage of Bortezomib formulation, a number of excipients are tried in these patents to stabilize the same. However, there is still a need for further development of an improved formulation of Bortezomib with better characteristics. Conclusion: Extensive research has been carried out on various processes for preparing Bortezomib and the composition thereof. This type of dynamic research will clear the path for many generic players in the United States, which lead to the reduction of the price of the composition and thereby enhancing global health care at cheaper prices.
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Kunst, Manuel, and Ulrike Kaufmann. "Authorized Generics and Biosimilars as Part of Drug Life Cycle Management." GRUR International 69, no. 11 (2020): 1105–12. http://dx.doi.org/10.1093/grurint/ikaa116.

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Abstract Nowadays there is no longer a clear distinction between innovative pharmaceutical companies and generic and biosimilar manufacturers. The latter seek patent protection for new formulations or medical uses of known pharmaceuticals, and originators have responded by building their own generic divisions. Through them, innovative pharmaceutical companies are able to launch their own generics or biosimilars to cushion the loss of revenues after the expiry of blockbuster patents. In particular, in recent years so-called authorized generics and biosimilars have received increased attention as part of patent expiry strategies.
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Meshram, Deepak, Khushbo Bhardwaj, Charulata Rathod, Gail B. Mahady, and Kapil K. Soni. "The Role of Leukotrienes Inhibitors in the Management of Chronic Inflammatory Diseases." Recent Patents on Inflammation & Allergy Drug Discovery 14, no. 1 (2020): 15–31. http://dx.doi.org/10.2174/1872213x14666200130095040.

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Background: Leukotrienes are powerful mediators of inflammation and interact with specific receptors in target cell membrane to initiate an inflammatory response. Thus, Leukotrienes (LTs) are considered to be potent mediators of inflammatory diseases including allergic rhinitis, inflammatory bowel disease and asthma. Leukotriene B4 and the series of cysteinyl leukotrienes (C4, D4, and E4) are metabolites of arachidonic acid metabolism that cause inflammation. The cysteinyl LTs are known to increase vascular permeability, bronco-constriction and mucus secretion. Objectives: To review the published data for leukotriene inhibitors of plant origin and the recent patents for leukotriene inhibitors, as well as their role in the management of inflammatory diseases. Methods: Published data for leukotrienes antagonists of plant origin were searched from 1938 to 2019, without language restrictions using relevant keywords in both free text and Medical Subject Headings (MeSH terms) format. Literature and patent searches in the field of leukotriene inhibitors were carried out by using numerous scientific databases including Science Direct, PubMed, MEDLINE, Google Patents, US Patents, US Patent Applications, Abstract of Japan, German Patents, European Patents, WIPO and NAPRALERT. Finally, data from these information resources were analyzed and reported in the present study. Results: Currently, numerous anti-histaminic medicines are available including chloropheneremine, brompheniramine, cetirizine, and clementine. Furthermore, specific leukotriene antagonists from allopathic medicines are also available including zileuton, montelukast, pranlukast and zafirlukast and are considered effective and safe medicines as compared to the first generation medicines. The present study reports leukotrienes antagonistic agents of natural products and certain recent patents that could be an alternative medicine in the management of inflammation in respiratory diseases. Conclusion: The present study highlights recent updates on the pharmacology and patents on leukotriene antagonists in the management of inflammation respiratory diseases.
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33

Drysdale, Douglas. "Ethics and patents: are patents bad or just misunderstood?" Drug Discovery Today: TARGETS 3, no. 6 (2004): 253–54. http://dx.doi.org/10.1016/s1741-8372(04)02461-2.

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34

Brown, James AL. "Patent spotlight: small-molecule lysine acetyltransferase inhibitors (KATi)." Pharmaceutical Patent Analyst 9, no. 1 (2020): 17–28. http://dx.doi.org/10.4155/ppa-2019-0025.

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Lysine (or histone) acetyltransferases plays a key role in genome maintenance and gene regulation and dysregulation of acetylation is a recognized feature of many diseases, including several cancers. Here, the patent landscape surrounding lysine acetyltransferase inhibitors (KATi or HATi), with a focus on small-molecule compounds, is outlined and assessed. Overall, the 36 KATi-specific patents found were categorized into two distinct groups: specific small-molecule inhibitors (compounds and molecules) and patents applying KATi for targeted disease treatment. These patents recognize the emergent potential of KATi to significantly impact on the management of many diseases (including multiple cancer types, neurological disorders and immunological syndromes), improving the range of treatments (and drug classes) available for personalized medicine.
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35

Ekinci, Elmira, Sagar Rohondia, Raheel Khan, and Qingping P. Dou. "Repurposing Disulfiram as An Anti-Cancer Agent: Updated Review on Literature and Patents." Recent Patents on Anti-Cancer Drug Discovery 14, no. 2 (2019): 113–32. http://dx.doi.org/10.2174/1574892814666190514104035.

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Background:Despite years of success of most anti-cancer drugs, one of the major clinical problems is inherent and acquired resistance to these drugs. Overcoming the drug resistance or developing new drugs would offer promising strategies in cancer treatment. Disulfiram, a drug currently used in the treatment of chronic alcoholism, has been found to have anti-cancer activity.Objective:To summarize the anti-cancer effects of Disulfiram through a thorough patent review.Methods:This article reviews molecular mechanisms and recent patents of Disulfiram in cancer therapy.Results:Several anti-cancer mechanisms of Disulfiram have been proposed, including triggering oxidative stress by the generation of reactive oxygen species, inhibition of the superoxide dismutase activity, suppression of the ubiquitin-proteasome system, and activation of the mitogen-activated protein kinase pathway. In addition, Disulfiram can reverse the resistance to chemotherapeutic drugs by inhibiting the P-glycoprotein multidrug efflux pump and suppressing the activation of NF-kB, both of which play an important role in the development of drug resistance. Furthermore, Disulfiram has been found to reduce angiogenesis because of its metal chelating properties as well as its ability to inactivate Cu/Zn superoxide dismutase and matrix metalloproteinases. Disulfiram has also been shown to inhibit the proteasomes, DNA topoisomerases, DNA methyltransferase, glutathione S-transferase P1, and O6- methylguanine DNA methyltransferase, a DNA repair protein highly expressed in brain tumors. The patents described in this review demonstrate that Disulfiram is useful as an anti-cancer drug.Conclusion:For years the FDA-approved, well-tolerated, inexpensive, orally-administered drug Disulfiram was used in the treatment of chronic alcoholism, but it has recently demonstrated anti-cancer effects in a range of solid and hematological malignancies. Its combination with copper at clinically relevant concentrations might overcome the resistance of many anti-cancer drugs in vitro, in vivo, and in patients.
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36

Morris, Kelly. "HIV drug patents in the spotlight." Lancet Infectious Diseases 9, no. 11 (2009): 660–61. http://dx.doi.org/10.1016/s1473-3099(09)70272-5.

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37

Hemphill, C. S., and B. Sampat. "Drug Patents at the Supreme Court." Science 339, no. 6126 (2013): 1386–87. http://dx.doi.org/10.1126/science.1235857.

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38

Marshall, E. "Drug Metabolite Patents Prompt Legal Battle." Science 325, no. 5941 (2009): 665. http://dx.doi.org/10.1126/science.325_665a.

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39

Coghlan, Andy. "Cheap drug dodges big pharma patents." New Scientist 193, no. 2585 (2007): 14. http://dx.doi.org/10.1016/s0262-4079(07)60017-7.

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40

Hemphill, C. Scott, and Bhaven N. Sampat. "When Do Generics Challenge Drug Patents?" Journal of Empirical Legal Studies 8, no. 4 (2011): 613–49. http://dx.doi.org/10.1111/j.1740-1461.2011.01235.x.

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41

Attaran, Amir. "Drug Patents Abroad: The Author Responds." Health Affairs 23, no. 5 (2004): 281. http://dx.doi.org/10.1377/hlthaff.23.5.281.

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42

Melton, Lisa. "India's onslaught on drug patents continues." Nature Biotechnology 31, no. 10 (2013): 869. http://dx.doi.org/10.1038/nbt1013-869a.

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43

Vass, A. "WTO relaxes rule on drug patents." BMJ 323, no. 7322 (2001): 1146. http://dx.doi.org/10.1136/bmj.323.7322.1146b.

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44

Kaur, Shahid Sukhbir. "Pulmonary drug delivery system: newer patents." Pharmaceutical Patent Analyst 6, no. 5 (2017): 225–44. http://dx.doi.org/10.4155/ppa-2017-0019.

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45

Raj, Gerard Marshall, Rekha Priyadarshini, and Jayanthi Mathaiyan. "Drug patents and intellectual property rights." European Journal of Clinical Pharmacology 71, no. 4 (2015): 403–9. http://dx.doi.org/10.1007/s00228-015-1811-5.

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46

Sterckx, Sigrid. "Can drug patents be morally justified?" Science and Engineering Ethics 11, no. 1 (2005): 81–92. http://dx.doi.org/10.1007/s11948-005-0059-3.

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47

Tyagi, Shilpi, and DK Nauriyal. "Do innovative activities matter to Indian drug and pharmaceutical firms? An application to export performance." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 13, no. 4 (2017): 193–205. http://dx.doi.org/10.1177/1741134317716221.

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This paper analyzes the R&D and exports profile of Indian drug and pharmaceutical industry during the period 2000–2014. The present paper examines how R&D expenditure and patent impact export performance of the Indian drug and pharmaceutical firms. The study period from 2000 to 2014 has been characterized by a rapid growth in industry’s innovative activity, as part of the strategic shift, induced by the Patents (Amendment) Act, 2005. Using the real financial data for the top 91 publicly listed Indian domestic pharmaceutical companies, the study provides new evidence on firm-level export performance of the Indian drugs and pharmaceutical industry. Generalized Method of Movements estimator developed by Blundell and Bond is applied. The empirical findings of the study reveal that increased R&D intensity, higher patent count and firm’s size are important determinants of firm-level export performance.
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48

Tozi, Fábio. "INTELLECTUAL PROPERTY PROTECTION AND DRUG PATENTS IN BRAZIL." Mercator 19, no. 2020 (2020): 1–15. http://dx.doi.org/10.4215/rm2020.e19021.

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The article aims to reconstruct the central events of the Intellectual Property (IP) protection system in Brazil, from the first colonial orders to the Intellectual Property Law (1996). Two periods are identified: in the first, we observe the internalizing of innovations, improving the country's development, but preventing the patenting of medicines and food. The second, recent, explains an adaptation of national laws to international ones, suppressing the previous exceptions. The historical change in regulations reveals that patents have become symbolic elements of globalization process. The geopolitics of this process is presented in a review on the influence of the US Special 301 Reports on Brazilian politics. Finally, the article seeks to show that politics is not limited to the legal system, presenting the annulment of patents in Brazil during public health crises. In this sense, the text brings elements of the international discussion on the suppression of patents to face the COVID-19 pandemic, updating the debate on territorial sovereignty.
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Bair, Kenneth W. "Patent Update: Cancer Drug Development: Current Research and Patents - 1991 - Part 2." Current Opinion on Therapeutic Patents 2, no. 11 (1992): 1769–802. http://dx.doi.org/10.1517/13543776.2.11.1769.

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50

Komati, Someshwar, Suryakanta Swain, Muddana Eswara Bhanoji Rao, Bikash Ranjan Jena, and Vishali Dasi. "Mucoadhesive Multiparticulate Drug Delivery Systems: An ExtensiveReview of Patents." Advanced Pharmaceutical Bulletin 9, no. 4 (2019): 521–38. http://dx.doi.org/10.15171/apb.2019.062.

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Innovations in pharmaceutical research are striving for designing newer drug therapies toeradicate deadly diseases. Strategies for such inventions always flourish with keys and objectivesof minimal adverse effects and effective treatment. Recent trends in pharmaceutical technologyspecify that mucoadhesive drug delivery system is particularly appropriate than oral controlrelease, for getting local systematic delivery of drugs in GIT for an extended interval of time ata predetermined rate. However, it is somehow expensive and unpleasant sensation for somepatients, but still it is needful for getting short enzymatic activity, simple administration withoutpain and evasion of fast pass metabolism. Usually the vehicles employed in drug delivery ofmucoadhesive system have a significant impact that draws further attention to potential benefitslike improved bioavailability of therapeutic agents, extensive drug residence time at the site ofadministration and a comparatively faster drug uptake into the systemic circulation. The drugrelease from mucoadhesive multiparticulates is contingent on several types of factors comprisingcarrier need to produce the multiparticles and quantity of medication drug contained in them.Mucoadhesion is characterized by selected theories and mechanisms. Various strategiesemergent in mucoadhesive multiparticulate drug delivery system (MMDDS) by in-vitro as wellas ex-vivo description and characterization are also critically discussed. Apart from these, theprimary focus during this review is to highlight current patents, clinical status, and regulatorypolicy for enhancement of mucoadhesive multi-particulate drug delivery system in the present scenario.<br />
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