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Journal articles on the topic 'Generic Drugs Market'

Author: Grafiati

Published: 5 June 2025

Last updated: 1 August 2025

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1

Nazmus, Saqueeb. "MARKET RESEARCH ON POPULAR ANTIHYPERTENSIVE DRUGS." DIU Journal of Health and Life Sciences 2, no. 01 & 02 (2024): 39–43. http://dx.doi.org/10.36481/diujhls.v01i1.5f6ak424.

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Market research is an organized effort to gather information about target markets or customers. The purpose of market research on antihypertensive drugs is to identify the most popular antihypertensive drugs. For this purpose, Different hospitals were visited and 100 prescriptions for antihypertensive patients were collected. The result depicts that Betaloc (Generic name: Metoprolol tartrate),Diretic DS (Generic name: Frusemideand Spironolactone), Carvista (Generic name: Carvedilol), Nidocard(Generic name: nitroglycerin), Metacard MR (Generic name: Trimetazidine Hydrochloride), Ramace (Generic

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Saqueeb, Nazmus. "Market Research On Popular Antihypertensive Drugs." DIU Journal of Allied Health Sciences 2, no. 01 & 02 (2024): 39–43. https://doi.org/10.36481/diujahs.v01i1.5f6ak424.

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Market research is an organized effort to gather information about target markets or customers. The purpose of market research on antihypertensive drugs is to identify the most popular antihypertensive drugs. For this purpose, Different hospitals were visited and 100 prescriptions for antihypertensive patients were collected. The result depicts that Betaloc (Generic name: Metoprolol tartrate),Diretic DS (Generic name: Frusemideand Spironolactone), Carvista (Generic name: Carvedilol), Nidocard(Generic name: nitroglycerin), Metacard MR (Generic name: Trimetazidine Hydrochloride), Ramace (Generic

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3

Nazmus, Saqueeb and Shakil Ahmed. "Market research on Popular Antihypertensive Drugs." DIU Journal of Health and Life Sciences 2, no. 1 & 2 (2015): 39–43. https://doi.org/10.5281/zenodo.11076990.

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Market research is an organized effort to gather information about target markets or customers. The purpose of market research on antihypertensive drugs is to identify the most popular antihypertensive drugs. For this purpose, Different hospitals were visited and 100 prescriptions for antihypertensive patients were collected. The result depicts that Betaloc (Generic name: Metoprolol tartrate), Diretic DS (Generic name: Frusemideand Spironolactone), Carvista (Generic name: Carvedilol), Nidocard(Generic name: nitroglycerin), Metacard MR (Generic name: Trimetazi

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4

Jang, Suhyun, and Sunmee Jang. "Trends in Pharmaceutical Market Structure and Generic Drug Utilization in the Korean National Health Security System (2007-2017)." Yakhak Hoeji 67, no. 3 (2023): 205–13. http://dx.doi.org/10.17480/psk.2023.67.3.205.

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We aimed to analyze the market structure and changes in the market share of new drugs, original drugs, and generic drugs in the pharmaceutical market over the past ten years. We utilized national health insurance claims data, including both national health insurance and medical aid, from 2007 to 2017 to establish pharmaceutical expenditure and usage data. The drugs are categorized into new drugs, original drugs (expired patents), and generic drugs. Furthermore, we classified the original drugs as single-source and multi-source original drugs based on whether generic drugs had entered the marke

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Konuri, Dinesh Chandra, Mamillapalli S., A. Elphine P., and Brahma S. R. Desu. "COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 75–87. http://dx.doi.org/10.22270/ijdra.v3i1.159.

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A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets

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Kuveria, Helly, Zuki Patel, Manvendra Raval, and Maitreyi Zaveri. "Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil." International Journal of Drug Regulatory Affairs 12, no. 2 (2024): 65–72. http://dx.doi.org/10.22270/ijdra.v12i2.676.

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Objective: The generic pharmaceutical markets in Mexico, Guatemala, and Brazil are influenced by distinct regulatory frameworks, production and distribution dynamics, and marketing strategies, which shape lifecycle management. Regulatory policies, market competition, and healthcare initiatives impact accessibility, affordability, and quality, presenting both challenges and opportunities for enhancement in these areas. Summary: This thesis offers an in-depth examination of lifecycle management strategies in the generic pharmaceutical markets of Mexico, Guatemala, and Brazil. Generic drugs are c

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Craddock, Kathleen. "Improving Generic Drug Approval at the FDA." Michigan Journal of Environmental & Administrative Law, no. 7.2 (2018): 421. http://dx.doi.org/10.36640/mjeal.7.2.improving.

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Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “

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Samson, Marvin. "Generic injectable drugs: From idea to market." American Journal of Health-System Pharmacy 60, no. 11 (2003): 1117–22. http://dx.doi.org/10.1093/ajhp/60.11.1117.

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Masuda, Sachiko. "The trend in patent infringement litigation against generic drugs or biosimilars in Japan." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 15, no. 1 (2019): 10–17. http://dx.doi.org/10.1177/1741134319826338.

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The timing of market entry for generic drugs or biosimilars based on patent expiration is not always clear for producers of generic drugs and biosimilars or brand-name drug companies, because of an uncertainty due to patent infringement, the market environment, and legislation. In Japan, the policy of promoting the use of generic drugs began in the early 2000s, and the government’s target for generic drug use rate is 80% by 2020. In addition to this drastic change in the market environment, changes in legislation have complicated the timing of market entry for generic drugs and biosimilars. Al

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Bhavna, Chandnani*1 Vikram Pandya2 Chaudhari Komal3 Patel Bhoomi4 Kapadia Krishna5 Sheikh Fiza6 Rajput Suraj6. "Research Article Quality Effectiveness Assessment Study On Diffrent Brands Of Paracetamol Tablet Available In Navsari Market." International Journal in Pharmaceutical Sciences 2, no. 3 (2024): 494–501. https://doi.org/10.5281/zenodo.10822739.

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Drugs are any substance either biological or chemical and when consumed affects the physiological function of the body. These drugs are classified as OTC drugs or Prescription drugs. Both OTC drugs and Prescription drugs are available as Generic drugs or Branded/Proprietary drugs. While Branded drugs are protected by a patent for a particular number of years, generic drugs are not. Generic drugs only have to meet the same bio-equivalence requirement as their branded counterparts. Also, Branded drugs take a lot of time to get approved while generic drugs take a much lesser time. Due to the time

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Guan, Xiaodong, Ye Tian, Dennis Ross-Degnan, Chunxia Man, and Luwen Shi. "Interrupted time-series analysis of the impact of generic market entry of antineoplastic products in China." BMJ Open 8, no. 7 (2018): e022328. http://dx.doi.org/10.1136/bmjopen-2018-022328.

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ObjectivesThe rapid growth of pharmaceutical costs is a major healthcare issue all over the world. The high prices of new drugs, especially those for cancer, are also a concern for stakeholders. Generic drugs are a major price-reducing opportunity and provide more societal value. The aim of this research is to analyse the impact of generic entry on the volume and cost of antineoplastic agents in China.MethodsAn interrupted time-series design examined monthly sales of three antineoplastic drugs (capecitabine, decitabine, imatinib) from 699 public hospitals during January 2011 to June 2016. The

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Falcone, Nicholas. "Repositioning Generics: The Comparative Value of Liability in FDA's Proposed Rule on Labeling." American Journal of Law & Medicine 41, no. 2-3 (2015): 483–504. http://dx.doi.org/10.1177/0098858815591529.

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Generic drugs occupy a unique position in the U.S. pharmaceuticals market. On one hand, generics are a product of basic free-market economic reasoning. Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) based on the uncontroversial assumption that inexpensive generic competition would reduce prescription drug costs. On the other hand, the generic drug industry is primarily a regulatory creation; Hatch-Waxman facilitates generic competition by permitting generic manufacturers to rely heavily on prior expenditures of pioneer drug manufacturers, inc

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G., Raja Mohan Reddy, M. P. Venkatesh, Achin J., and Pramod Kumar T.M. "REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA." International Journal of Drug Regulatory Affairs 2, no. 2 (2018): 7–15. http://dx.doi.org/10.22270/ijdra.v2i2.126.

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Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and ar

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Vokinger, Kerstin Noëlle, Aaron S. Kesselheim, Jerry Avorn, and Ameet Sarpatwari. "Strategies That Delay Market Entry of Generic Drugs." JAMA Internal Medicine 177, no. 11 (2017): 1665. http://dx.doi.org/10.1001/jamainternmed.2017.4650.

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Nazim, N. Haider. "A Comparative Analysis of Generic Drug Regulations and Pricing Differences in the United States and Other Regions." Journal of Scientific and Engineering Research, 6, no. 11 (2019): 315–19. https://doi.org/10.5281/zenodo.13337955.

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This paper provides a comparative analysis of generic drug regulations and pricing differences in the United States and other regions, focusing on ensuring safety, efficacy, and affordability in the pharmaceutical market. By examining regulatory frameworks, approval processes, and market dynamics governing generic drugs, as well as the impact of pricing variations on accessibility and affordability for consumers, key insights are revealed. The analysis underscores the importance of strategic planning, regulatory compliance, and market adaptation for successful brand positioning in competitive

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Mansfield, Sarah J. "Generic drug prices and policy in Australia: room for improvement? A comparative analysis with England." Australian Health Review 38, no. 1 (2014): 6. http://dx.doi.org/10.1071/ah12009.

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Objective To assess the degree to which reimbursement prices in Australia and England differ for a range of generic drugs, and to analyse the supply- and demand-side factors that may contribute to these differences. Methods Australian and English reimbursement prices were compared for a range of generic drugs using pricing information obtained from government websites. Next, a literature review was conducted to identify supply- and demand-side factors that could affect generic prices in Australia and England. Various search topics were identified addressing potential supply-side (e.g. market a

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Memedovich, Ally, Brian Steele, Taylor Orr, et al. "Predicting patent challenges for small-molecule drugs: A cross-sectional study." PLOS Medicine 22, no. 2 (2025): e1004540. https://doi.org/10.1371/journal.pmed.1004540.

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Background The high cost of prescription drugs in the United States is maintained by brand-name manufacturers’ competition-free period made possible in part through patent protection, which generic competitors must challenge to enter the market early. Understanding the predictors of these challenges can inform policy development to encourage timely generic competition. Identifying categories of drugs systematically overlooked by challengers, such as those with low market size, highlights gaps where unchecked patent quality and high prices persist, and can help design policy interventions to he

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Nazim, N. Haider. "Generic Drugs: Impact on Patients, Physicians, Payers, and the Healthcare System." European Journal of Advances in Engineering and Technology 6, no. 8 (2019): 75–78. https://doi.org/10.5281/zenodo.13319289.

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This paper delves into the profound impact of generic drugs on patients, physicians, payers, and the healthcare system, emphasizing their role in enhancing healthcare affordability, accessibility, and quality. Through cost-effective alternatives, improved access to essential medications, and increased medication adherence, generic drugs have revolutionized healthcare delivery and treatment outcomes. By utilizing real-world data and evidence-based approaches, stakeholders can measure the economic and clinical impact of generics, facilitating informed decision-making and policy development. The

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Riku, Juichi. "Current Situation for Generic Drugs in Japan." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 2, no. 3 (2005): 219–31. http://dx.doi.org/10.1057/palgrave.jgm.4940073.

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Although the Japanese pharmaceutical market is the second largest market in the world, the share of generics is extremely low when compared with those in the USA, the UK and Germany. The reason for this is that there are several obstacles to quick access to, and market penetration of, generics that would be incomprehensible to foreign companies. In Japan, systems such as substitution of generics for brands, reference pricing, etc have not yet been implemented. Similarly, the complete separation of prescribing and dispensing medicines has not occurred in Japan, where 48 per cent of medical inst

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Liu, Ya-Ming, and Chee-Ruey Hsieh. "Profit-Seeking Behavior of Medical Providers and Generic Competition in the Pharmaceutical Market: Evidence from Taiwan." B.E. Journal of Economic Analysis & Policy 14, no. 1 (2013): 241–75. http://dx.doi.org/10.1515/bejeap-2013-0066.

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Abstract Promoting competition between brand-name and generic drugs has long been recognized as an approach adopted to save on health care costs. However, there are substantial variations in the extent of the generic competition across countries. This study empirically estimates the determinants of the generic market share in Taiwan, where medical providers are in a position to profit directly from the sale of prescription drugs. Our empirical results point out that the profit-seeking behavior of medical providers plays an important and dominant role behind generic competition in the pharmaceu

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Rao, Nagaraj N. "CHALLENGES FOR GENERIC DRUG PRODUCERS." INDIAN DRUGS 55, no. 11 (2018): 5–6. http://dx.doi.org/10.53879/id.55.11.p0005.

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In the fiercely competitive global market for generic drugs, the complexities and interconnectivities come to the fore when a drug is recalled. In recent months, as you may be aware, the sartans (also known as AT1 receptor antagonists, angiotensin II receptor blockers/antagonists) have come into the limelight due to the recall of some of them from the regulated markets of USA and Europe.

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Matsuieva, Julia. "The impact of generic medicines on the European pharmaceutical market: The example of Poland." Ekonomia 23, no. 4 (2018): 251–60. http://dx.doi.org/10.19195/2084-4093.23.4.20.

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The impact of generic medicines on the European pharmaceutical market: The example of PolandIn this paper has been done a review of the existing situation on European pharmaceutical market. It was found that the Polish pharmaceutical market is quite different from other countries of the European Union. The share of generic medicines in Poland is the highest in the European Union. Quantitatively about 85% of the pharmaceutical market is composed of generic drugs. The social role of generics is expressed in their accessibility, affordable price, diversity and security for the most vulnerable par

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Nguyen,, Nguyen Xuan, Steven Sheingold, Arielle Bosworth, Rachael Zuckerman, and Thomas Buchmueller. "Effect of Market Entry on Generic Drug Prices: Medicare Data 2007-2022." International Journal of Research and Innovation in Social Science IX, no. I (2025): 1485–96. https://doi.org/10.47772/ijriss.2025.9010123.

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Using the Medicare Part D drug event (PDE) data from 2007 to 2022, and both fixed effects or random effects at the drug level, we estimate the relationship of competitors and prices within each drug level while controlling for factors across drugs for 3 periods, 2007-11, 2012-15, and 2016-2019. We follow a drug 24 months and 36 months after first generic entry to examine whether the relationship between number of competitors and price would change over time. We find that in recent years new generic markets continue to be competitive. Drug prices fall with increasing number of generic competito

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Pyatigorskaya, Natalia, Andrei Meshkovski, Zhanna Aladysheva, et al. "Export Potential of the Russian Pharmaceutical Market and its Prospects." International Journal of Engineering & Technology 7, no. 4.38 (2018): 1214. http://dx.doi.org/10.14419/ijet.v7i4.38.27766.

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Export of medicines is one of the most profitable businesses, which attracts the attention of an increasing number of producers. The international medicines’ trade largely depends on national or regional regulatory mechanisms. In addition, the export terms and conditions differ for various categories of medicines. Innovative drugs account for the main share of the global medicines’ export. Therefore, export of innovative drugs developed in Russia to advanced countries is the most economically profitable direction. Export of generic drugs can bring considerable revenue to the producer and the s

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Prof.(Dr.) Mohd.Wasiullah, Prof (Dr ). Mohd Wasiullah, Prof (Dr ). Piyush Yadav, and Sushil yadav. "“Concept of Generic Drug Product Development and Challenges”." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 2691–98. https://doi.org/10.35629/4494-100226912698.

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The rising cost of healthcare has made the availability of affordable medications a pivotal concern for patients and healthcare systems worldwide. Generic drugs, which are therapeutically equivalent to brand-name counterparts, provide a crucial solution by offering these medications at significantly lower prices after the expiration of patent protections. This review article delves into the comprehensive landscape of generic drug product development, highlighting the regulatory frameworks, development processes, and the various challenges that manufacturers face in bringing these cost-effectiv

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Shanmugarajan, Dayanidhi. "An overview of biosimilars." International Journal of Basic & Clinical Pharmacology 14, no. 1 (2024): 117–23. https://doi.org/10.18203/2319-2003.ijbcp20243846.

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The paradigm of pharmacological therapy in diseases is shifting from conventional small molecule drugs to biological drugs produced by living systems. Biological drugs have extensively ramified into therapies of various conditions such as autoimmune disorders, haematological conditions, cancers and others. Biological drugs are currently the diamond mine of the pharmaceutical drug market. Due to the enormous market value, other pharmaceutical companies are keen in producing and marketing generic versions of these innovator (reference) biologic companies, once the patents start to expire. These

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George, Jilu Lisbath. "India and the Global Generic Drug Market: Growth and Challenges Ahead." Journal of Research in Humanities and Social Science 13, no. 6 (2025): 99–104. https://doi.org/10.35629/9467-130699104.

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India is one of the leading manufacturers of pharmaceutical products globally and is the thirdlargest drug producer by volume. India accounts for 20 percent of the global export of generic medicines and is the world's pharmacy. Affordable and low-cost quality drugs make India the largest exporter of generic drugs. Even during the Covid -19 phase, India opened its hand as a vaccine supplier to the world. Though known as the medical superpower of the world, the Active Pharmaceutical Ingredients (API) for the production of various drugs are mainly imported from China, and this has become a matter

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Balkhi, Bander, Enrique Seoane-Vazquez, and Rosa Rodriguez-Monguio. "OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES: GENERIC COMPETITION, PRICING STRUCTURE, AND DISPERSION AMONG PAYERS." International Journal of Technology Assessment in Health Care 32, no. 6 (2016): 385–92. http://dx.doi.org/10.1017/s0266462316000623.

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Background: Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988–2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry.Methods: Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS). Descriptive statistics and segmented linear regression analyses were performed.Results: In t

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Paumgartten, Francisco José Roma, and Ana Cecilia Amado Xavier de Oliveira. "Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil." Ciência & Saúde Coletiva 22, no. 8 (2017): 2549–58. http://dx.doi.org/10.1590/1413-81232017228.04352017.

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Abstract Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), “similar” (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeab

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Yu, Yu, and Yi Zhao. "The effect of Affordable Care Act on the competition in the post-patent ethical drug market." International Journal of Pharmaceutical and Healthcare Marketing 8, no. 3 (2014): 314–47. http://dx.doi.org/10.1108/ijphm-12-2013-0066.

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Purpose – This paper aims to study the post-patent ethical drug market and simulate the impact of Patient Protection and Affordable Care Act (ACA) on individuals, health-care providers and pharmaceutical firms. US policymakers have been looking at various ways to curb rising health-care costs in USA, including ways to promote the use of generic drugs in lieu of brand drugs. In this broader context, the implementation of ACA in December 2013 will introduce major changes in the pharmaceutical market. Design/methodology/approach – To fully understand the impact of such policy changes, we develop

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Noel, Jason. "A high-stakes decision: Generic substitution of antiepileptic drugs." Mental Health Clinician 2, no. 5 (2012): 119–20. http://dx.doi.org/10.9740/mhc.n127375.

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In recent years, generic versions of several antiepileptic drugs have been approved and released to the US market. This article reviews some of the concerns associated with generic substitution of antiepileptic drugs.

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Carrera, Mariana, and Sofia Villas-Boas. "Generic Aversion and Observational Learning in the Over-the-Counter Drug Market." American Economic Journal: Applied Economics 15, no. 3 (2023): 380–410. http://dx.doi.org/10.1257/app.20200867.

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Through a labeling intervention at a national retailer, we test three hypotheses for consumer aversion to generic over-the-counter drugs: lack of information on the comparability of generic and brand drugs, inattention to their price differences, and uncertainty about generic quality that can be reduced with information on peer purchase rates. With a difference-in-differences strategy, we find that posted information on the purchases of other customers increases generic purchase shares significantly, while other treatments have mixed results. Consumers without prior generic purchases appear pa

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Eandi, Mario, and Carlo Della Pepa. "I farmaci “generici” in Italia: opportunità di ricerca e sviluppo di prodotti di qualità a prezzi competitivi." Farmeconomia. Health economics and therapeutic pathways 4, no. 2 (2003): 65–76. http://dx.doi.org/10.7175/fe.v4i2.770.

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Every drug whose copyright coverage has expired can be manufactured by a pharmaceutical company other than the one that developed it, giving rise to the market of the so-called generic drugs. It can be distinguished among two types of generic drugs: branded and unbranded, according to the choice of the manufacturer to assign it a fantasy name or to sell it with the name of the active principle, followed by the company’s name. In order to be accepted for marketing, every new drug has to pass the registration procedures of the Italian Ministry of Health, which are simplified for generics, as it’

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Gordon, Noa, Omer Ben-Aharon, Salomon M. Stemmer, Dan Greenberg, and Daniel A. Goldstein. "Price trajectories assessment for Medicare Part B generic anti-cancer drugs." Journal of Clinical Oncology 35, no. 15_suppl (2017): 6624. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.6624.

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6624 Background: Patented anti-cancer drugs launch prices have increased in recent years with subsequent increases after launch. Recently, large price increases of generic drugs were at the center of public attention in the United States. Our aim was to assess price changes with time for Medicare part B anti-cancer generic drugs and to understand how drug characteristics and market structure influence price trajectories. Methods: We included all Medicare part B anti-cancer drugs with price reported in both 2006 and 2016. Patent expiration dates were attached using the Medicare Drug Patent Expi

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Martina, Silvia, Dante Cornago, Livio Garattini, and I. H. A. G. O. Gruppo di studio I.H.A.G.O. "Incentivi ai farmaci generici a livello di ASL: l’osservatorio I.H.A.G.O." Farmeconomia. Health economics and therapeutic pathways 3, no. 2 (2002): 71–80. http://dx.doi.org/10.7175/fe.v3i2.746.

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Generic drugs are pharmaceutical products that contain an active substance whose patent-covered period expired and are marketed with the name of the molecule. The public health authorities of most EU countries agree on the importance of generic drugs in rationalising the pharmaceutical market, particularly by favouring reasonable pricing of “mature” products. In contrast with this wide consensus, the market share of generic drugs remains quite poor in Italy, despite recent regulatory incentives for the promotion of their use. The longlasting lack of specific laws - reference-price politics wer

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Xanthopoulou, Sofia-Sotiria, and Korina Katsaliaki. "Policies and perceptions on generic drugs: The case of Greece." Health Services Management Research 32, no. 1 (2018): 49–56. http://dx.doi.org/10.1177/0951484817752630.

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The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients’ and doctors’ attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (

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Maddela, Lakshmi Kanth, and Insukh Oh. "ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 41–61. http://dx.doi.org/10.22270/ijdra.v3i1.157.

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A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has its own regulatory strategy to approve and allow generic drugs in to the market, which is named as Generic Drug Submission Review. FDA would like to slash the review time of generic drug application without compromising the quality and efficacy of proposed generic drugs for the intended use and to make them available to consumers in short time as possible. FDA has introduced G

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de Magalhães, Jorge Lima, Luc Quoniam, and Núbia Boechat. "PHARMACEUTICAL MARKET AND OPPORTUNITY IN THE 21ST CENTURY FOR GENERIC DRUGS: A BRAZILIAN CASE STUDY OF OLANZAPINE." Problems of Management in the 21st Century 6, no. 1 (2013): 31–39. http://dx.doi.org/10.33225/pmc/13.06.31.

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This paper aimed to identify and analyse the evolution of the generic pharmaceutical market in Brazil, specifically olanzapine drugs. For this purpose, it has been demonstrated trends through access free tools. By bibliographical survey in indexed databases as well as official data in Brazil for generic drugs and public policy, it was analyzed and performed a case study . In 2012, global pharmaceutical industry surpassed US$ 950 billion in sales with trend to reach US$ 1,2 trillion by 2016. In Brazil market has grown in its global ranking, jumped from 10th place to 7th place in five years and

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Balkhi, Bander, Enrique Seoane-Vazquez, and Rosa Rodriguez-Monguio. "Medicaid osteoporosis drugs utilization and expenditures: the effect of generic drugs market entry." Journal of Pharmaceutical Health Services Research 7, no. 4 (2016): 217–24. http://dx.doi.org/10.1111/jphs.12144.

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Minn, Mari. "Development of Orphan Drugs under European Regulatory Incentives and Patent Protection." European Journal of Health Law 24, no. 3 (2017): 239–63. http://dx.doi.org/10.1163/15718093-12341401.

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AbstractThis article analyses how the regulatory incentives provided by Regulation 141/2000 affect orphan drug development and generic market entry. It seeks to find out how the regulatory incentives work in combination with patent protection, and whether in combination they foster orphan drug innovation and overall patient access, or rather hinder the latter. The article argues that even though the regulatory incentives are targeted to fostering innovation and early generic market access, when combined with patent protection, the generic entry is likely blocked or delayed.

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Lofgren, Hans. "Generic drugs: international trends and policy developments in Australia." Australian Health Review 27, no. 1 (2004): 39. http://dx.doi.org/10.1071/ah042710039.

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Public and private third-party payers in many countries encourage or mandate the use of generic drugs. This articleexamines the development of generics policy in Australia, against the background of a description of internationaltrends in this area, and related experiences of reference pricing programs. The Australian generics market remainsunderdeveloped due to a historical legacy of small Pharmaceutical Benefits Scheme price differentials betweenoriginator brands and generics. It is argued that policy measures open to the Australian government can be conceivedas clustering around two differe

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Ferreira, Pedro, and Hugo Barbosa. "Choice of mandatory prescribed drugs in Portugal: a consumers’ perspective." International Journal of Pharmaceutical and Healthcare Marketing 11, no. 4 (2017): 439–54. http://dx.doi.org/10.1108/ijphm-07-2016-0039.

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Purpose This paper aims to contribute to the understanding of what influences consumers’ choice of mandatory prescribed drugs, by looking with more detail to the substitution of branded drugs by generics. Specifically, this research looks at three factors that can influence this decision, namely, participative decision-making, perceived risk and price consciousness, within the recent changes introduced in the Portuguese pharmaceutical market by new legislation. Design/methodology/approach A cross-sectional study was conducted, using a self-administered questionnaire, to survey a sample of cons

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Shibata, Shoyo, Hitomi Kawaguchi, Ryotaro Uemura, and Takeshi Suzuki. "Emerging Growth of Orphan Drugs for Neurological Diseases in Japan: Potential Benefits for Both Patients and Pharmaceutical Companies." Journal of Regulatory Science 4, no. 3 (2016): 7–13. http://dx.doi.org/10.21423/jrs-v04n03p007.

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Despite the existence of numerous rare neurological diseases, no studies have been conducted on orphan drugs for neurological diseases available on the Japanese pharmaceutical market and their potential benefits. In this context, from a statistical perspective, we investigated 1) the market position of orphan drugs in Japan, and 2) the market penetration of generic medicines. To the best of our knowledge, this is the first empirical study to examine the current status and development strategy of orphan drugs approved for neurological diseases in the Japanese pharmaceutical market. The perspect

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Sfair, Silvia Antonio, Dirceu Da Silva, Mauro Neves Garcia, and Sérgio Luiz do Amaral Moretti. "Corporate Strategies for Generic Medicines in Brazil: A Study with the Sector’s Ten Largest CompaniesHttp://Dx.Doi.Org/10.5585/Riae.V10i1.1710." Revista Ibero-Americana de Estratégia 10, no. 1 (2011): 77–101. http://dx.doi.org/10.5585/ijsm.v10i1.1710.

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In Brazil, generic drugs are considered safe and effective and substantially cheaper than the so-called reference medicinal products. Due to this, generic drugs have become an important sector within the pharmaceutical market. However, topical studies are scarce and researchers focus on health professionals and direct sales. This article looks to expand on the understanding concerning the subject investigating the vision of those responsible for production, its relationship with physicians, government policies and delivery chain management in serving the consumer. To present this objective, in

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Hollis, Aidan, and Paul Grootendorst. "A comparison of mechanisms for setting generic drug prices in Canada." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 13, no. 1 (2016): 19–27. http://dx.doi.org/10.1177/1741134316669967.

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Canadian drug plan pricing of generic drugs is in a state of flux, with different plans adopting different approaches. The manner in which public plans pay for generic drugs can affect five policy goals: low generic drug prices, security of the drug supply, a reliance on reimbursement rules (thereby avoiding the need for drug plan managers to exercise discretion over reimbursement levels), low administrative burden and finally, the provision of adequate incentives for generics to enter the market. We review five pricing mechanisms: maximum prices, tiered pricing, tendering, benchmarking and ph

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Geitona, M., J. Kyriopoulos, D. Zavras, and J. Karamouzis. "PHP20 MARKET SHARE AND CHARACTERISTICS OF GENERIC DRUGS IN GREECE." Value in Health 6, no. 6 (2003): 717. http://dx.doi.org/10.1016/s1098-3015(10)61828-1.

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Xie, Jin. "Horizontal Shareholdings and Paragraph IV Generic Entry in the U.S. Pharmaceutical Industry." Antitrust Bulletin 66, no. 1 (2021): 100–112. http://dx.doi.org/10.1177/0003603x20985797.

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The Federal Trade Commission frequently files complaints against “pay-for-delay” settlements between brand-name pharmaceutical companies and generic-drug manufacturers, the latter of which challenge the monopoly status of patent-protected drugs. I document than when the top 20 generic shareholders have more substantial financial interests in the brand, then the likelihood that the brand enters into a settlement agreement with the first generic to challenge the brand goes up. The result of such a settlement is a payment from brand to generic, in exchange for the generic’s delayed entry. Only af

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Harshraj, Ahire Mr.Ajay Baykar Hema Kamalja Mahesh Kamalja Shekhar Baykar Arun Pathade. "THE EVOLUTION OF GENERIC MEDICINE HOW IT CAN MARKET DIFFERENT MEDICINE FOR DIFFERENT DISEASE." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 06 (2019): 12094–105. https://doi.org/10.5281/zenodo.3247337.

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<em>The main goal in introducing generic medicines into market was to decrease prices. After the expiry of patent or marketing rights of the patented drug, generic drugs are marketed. Generic drugs are available at affordable prices with maintaining quality. These ‘Generic’ formulations balance public interest as critical disease like cancer, AIDS etc. In situations where demand for medicines exceeds supply, criminally minded people tend to profit out of crime by manufacturing and distributing counterfeit medicines as а substitute for genuine medicines (branded and generic). India&

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Telrandhe, Anuksh, Ketakee Phadnis, Nilakshi Dhoble, Nitin Padole, and Jagdish Baheti. "A Review: A Comparative Study of Branded and Generic Anti-Hypertensive Drugs." Asian Journal of Pharmaceutical Research and Development 12, no. 2 (2024): 42–51. http://dx.doi.org/10.22270/ajprd.v12i2.1359.

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This comprehensive review investigates the market landscape of antihypertensive medications, undertaking a detailed comparative analysis of branded and generic options. In the face of rising global prevalence of hypertension, the study aims to provide a holistic perspective on the efficacy, safety, and market dynamics shaping the use of branded and generic drugs in the management of these chronic conditions. Utilizing data derived from market trends, sales analytics, and consumer preferences, the review scrutinizes the market behaviors and forces influencing the adoption of branded and generic

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Telrandhe, Anuksh, Ketki Phadnis, Nilakshi Dhoble, Nitin Padole, and Jagdish Baheti. "A Review: A Comparative Study of Branded and Generic Anti- Diabetic Drugs." Asian Journal of Pharmaceutical Research and Development 12, no. 2 (2024): 28–34. http://dx.doi.org/10.22270/ajprd.v12i2.1340.

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This comprehensive review investigates the market landscape of antihypertensive medications, undertaking a detailed comparative analysis of branded and generic options. In the face of rising global prevalence of hypertension, the study aims to provide a holistic perspective on the efficacy, safety, and market dynamics shaping the use of branded and generic drugs in the management of these chronic conditions. Utilizing data derived from market trends, sales analytics, and consumer preferences, the review scrutinizes the market behaviors and forces influencing the adoption of branded and generic

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