Academic literature on the topic 'Authorized generics'

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Journal articles on the topic "Authorized generics"

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Glass, Gregory. "Authorized Generics." Nature Reviews Drug Discovery 4, no. 12 (2005): 953–55. http://dx.doi.org/10.1038/nrd1906.

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Patel, JS, DR Baheti, and MP Wagh. "Authorized generics practice." Systematic Reviews in Pharmacy 1, no. 1 (2010): 106. http://dx.doi.org/10.4103/0975-8453.59520.

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Moon, J., J. Nkurunziza, A. Jambi, E. Seoane-Vazquez, J. Qian, and R. A. Hansen. "Generic competition and Authorized Generics in the United States." Value in Health 18, no. 3 (2015): A92. http://dx.doi.org/10.1016/j.jval.2015.03.540.

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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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McGee, Shelley-Ann Marion. "The economic and pricing impact of authorized generic medicines in South Africa." International Journal of Pharmaceutical and Healthcare Marketing 9, no. 1 (2015): 20–35. http://dx.doi.org/10.1108/ijphm-11-2013-0059.

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Purpose – This paper aims to examine whether authorized generics (AGs) have influenced prices and market shares in markets for molecules facing generic competition in South Africa. AGs (clones), which are identical to the originator brands, offer a solution for originator companies to protect their markets from independent generic (IG) competition. IG competitors have claimed that AGs have a negative impact on pricing and competition. Design/methodology/approach – In a retrospective analysis, pricing and quantity data for 24 months post generic entry were extracted for oral solid dosage form products which experienced generic entry into their markets between 2005 and 2011, divided into “Authorized generic affected” and “no authorized generic” markets. A series of indices was calculated, as well as market shares of competing originator and generic products, and the number of generic competitors determined. Indices and market share data for clone affected and unaffected groups were tested at 6, 12, 18 and 24 months using unmatched t-tests, at a 95 per cent significance level. Findings – None of the evaluated pricing indices showed a consistently significant difference existing between AG-affected and no-AG samples. The only variable for which the two samples consistently differed was market shares, with originator brands experiencing significantly more market share erosion in AG-affected markets. Pricing levels of generics and originator products as well as growth of numbers of generic competitors were similar in both AG-affected and no-AG groups. Originality/value – A study of this nature on the impacts of AGs in the South African generics has not been previously published and reflects the situation particular to the country.
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Gagne, Joshua J., Ameet Sarpatwari, and Rishi J. Desai. "Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products." Clinical Pharmacology & Therapeutics 105, no. 2 (2018): 313–15. http://dx.doi.org/10.1002/cpt.1283.

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Moran, Donald W., Steven M. Lieberman, and Kara L. Suter. "Banning Authorized Generics Equals Higher Federal Spending." Health Affairs 27, no. 1 (2008): 302–3. http://dx.doi.org/10.1377/hlthaff.27.1.302-a.

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Jones, Gregory H., Michael A. Carrier, Richard T. Silver, and Hagop Kantarjian. "Strategies that delay or prevent the timely availability of affordable generic drugs in the United States." Blood 127, no. 11 (2016): 1398–402. http://dx.doi.org/10.1182/blood-2015-11-680058.

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Abstract High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.
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Shcherbakova, Natalia, Marvin Shepherd, Kenneth Lawson, and Kristin Richards. "The Role of authorized generics in the prescription drug marketplace." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 8, no. 1 (2011): 28–40. http://dx.doi.org/10.1057/jgm.2011.6.

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Shcherbakova, N., M. Shepherd, K. Lawson, and K. Richards. "PHP98 THE ROLE OF AUTHORIZED GENERICS IN THE PRESCRIPTION DRUG MARKETPLACE." Value in Health 13, no. 3 (2010): A100. http://dx.doi.org/10.1016/s1098-3015(10)72478-5.

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Dissertations / Theses on the topic "Authorized generics"

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Wan, Jiangyun. "Essays on Competition in the Pharmaceutical Industry." FIU Digital Commons, 2015. http://digitalcommons.fiu.edu/etd/1900.

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Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.
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"Three Essays in Health Economics." Tulane University, 2020.

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Chiu, Ching-Fang, and 邱靖芳. "The antitrust study of Authorized Generic Drug and Product Hopping." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/76757079427716653146.

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碩士<br>國立交通大學<br>科技法律研究所<br>103<br>"Authorized Generics" and "Product Hopping" are two new strategies that the patented pharmaceutical companies used in recent years. People still argue whether these two new strategies are violations of competition law or not. To research these issues, the author introduced the relevant norms, the actual case, the other relevant opinion, and interviewed several attorneys, representatives of local Pharmaceutical companies and Big Pharma to find what they think about these issues. Hope to find the right way to analyze these two issues. The results showed if authorized generics entering the market competition in 180 days exclusive period could drive down the drugs' price. Only while authorized generics came along with reversely settlements will delay generic drugs to enter the market, this non-compete agreement shall use “rule of reason” to regulate. On the other hand, the results showed that in order to avoid a chilling effect, product hopping should not be totally prohibited by competition law. After the author compared different judgment standards, finally found product hopping should use “rule of reason” to balance the positive benefits and the competitive harms brought from the behavior. Hope this paper has some contributions in "authorized generics" and "product hopping" these two issues.
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Books on the topic "Authorized generics"

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Günther Rall: A memoir : Luftwaffe ace and NATO general : the authorized biography. Tangmere Productions, 2002.

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Tillotson, Michael. Dwin Bramall: The authorised biography of Field Marshal The Lord Bramall KG, GCB, OBE, MC. Sutton, 2005.

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Shapiro, Robert Jason. From inventors to predators: Have brand firms crossed the line by marketing authorized generics? 2007.

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Nelson, Edward R., and Jerry G. Wright. Authorized Generic Drugs: Short and Long-Term Competitive Effects. Nova Science Publishers, Incorporated, 2012.

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William A, Schabas. Part 1 Establishment of the Court: Institution de la Cour, Art.4 Legal status and powers of the Court/Régime et pouvoirs juridiques de la Cour. Oxford University Press, 2016. http://dx.doi.org/10.1093/law/9780198739777.003.0006.

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This chapter comments on Article 4 of the Rome Statute of the International Criminal Court. Article 4 is described as ‘an umbrella provision upon which agreement had been reached, establishing in generic terms the international legal personality of the Court and such functional legal capacity as might be necessary’. Consisting of two paragraphs, the article declares that the Court has ‘international legal personality’, and that the Court may exercise its functions and powers on the territory of any State Party, but only of course to the extent that these are authorized by the Statute itself.
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Lett, Brian. SOE's Mastermind: The Authorised Biography of Major General Sir Colin Gubbins KCMG, DSO, MC. Pen & Sword Books Limited, 2016.

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Sayle, Timothy, Jeffrey A. Engel, Hal Brands, and William Inboden, eds. The Last Card. Cornell University Press, 2019. http://dx.doi.org/10.7591/cornell/9781501715181.001.0001.

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This book is the real story of how George W. Bush came to double-down on Iraq in the highest stakes gamble of his entire presidency. It offers an unprecedented look into the process by which Bush overruled much of the military leadership and many of his trusted advisors to authorize the deployment of roughly 30,000 additional troops to the warzone in a bid to save Iraq from collapse in 2007. The adoption of a new counterinsurgency strategy and surge of new troops into Iraq altered the American posture in the Middle East for a decade to come. The book provides access to the deliberations among the decision-makers on Bush's national security team as they embarked on that course. In their own words, George W. Bush, Dick Cheney, Stephen Hadley, Condoleezza Rice, Joshua Bolten, Robert Gates, and others, recount the debates and disputes that informed the process as Bush weighed the historical lessons of Vietnam against the perceived strategic imperatives in the Middle East. For a president who had earlier vowed never to dictate military strategy to generals, the deliberations in the Oval Office and Situation Room in 2006 constituted a trying and fateful moment. Bush risked losing public esteem and courted political ruin by refusing to disengage from the costly war in Iraq. The book is a portrait of leadership in the Bush White House. The personal perspectives are complemented by critical assessments. Taken together, they are a first draft of the history of the surge and new chapter in the history of the American presidency.
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Book chapters on the topic "Authorized generics"

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Schildkraut, Marc G. "Actavis, Authorized Generics, and the Future of Antitrust Law." In Healthcare Antitrust, Settlements, and the Federal Trade Commission. Emerald Publishing Limited, 2018. http://dx.doi.org/10.1108/s0193-589520180000028002.

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Conference papers on the topic "Authorized generics"

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Angulo, Karem, and Alexander A. Ramirez M. "Generic Authorizer: Authorizer Generic Banking Operations." In 2012 International Conference on Information Science and Applications (ICISA). IEEE, 2012. http://dx.doi.org/10.1109/icisa.2012.6220975.

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Simplício Jr., Marcos Antonio, Vlad Coroama, Yeda R. Venturini, Tereza Carvalho, Mats Naslund, and Makan Pourzandi. "PHD A Generic and Flexible Architecture for IPTV in Authorized Domains." In 2009 International Conference on Advanced Information Networking and Applications. IEEE, 2009. http://dx.doi.org/10.1109/aina.2009.18.

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Bedi, Gurjendra S. "Overview of NRC NUREG-1482, Revision 2, Guidelines for Inservice Testing at Nuclear Power Plants: Inservice Testing of Pumps and Valves, and Inservice Examination and Testing of Dynamic Restrains (Snubbers) at Nuclear Power Plants." In ASME/NRC 2014 12th Valves, Pumps, and Inservice Testing Symposium. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/nrc2014-5030.

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The U.S. Nuclear Regulatory Commission (NRC) staff issued Revision 2 to NUREG-1482, “Guidelines for Inservice Testing at Nuclear Power Plant,” to assist the nuclear power plant licensees in establishing a basic understanding of the regulatory basis for pump and valve inservice testing (IST) programs and dynamic restraints (snubbers) inservice examination and testing programs. Since the Revision 1 issuance of NUREG-1482, certain tests and measurements required by earlier editions and addenda of the American Society of Mechanical Engineers (ASME) Code for Operation and Maintenance of Nuclear Power Plants (OM Code) have been clarified, updated, revised or eliminated. The revision to NUREG-1482 incorporates and addresses those changes, and includes the IST programs guidelines related to new reactors. The revised guidance incorporates lessons learned and experience gained since the last issue. This paper provides an overview of the contents of the NUREG-1482 and those changes and discusses how they affect NRC guidance on implementing pump and valve inservice testing (IST) programs. For the first time, this revision added dynamic restraint (snubber) inservice examination and testing program guidelines along with pump and valve IST programs. This paper highlights important changes to NUREG-1482, but is not intended to provide a complete record of all changes to the document. The NRC intends to continue to develop and improve its guidance on IST methods through active participation in the ASME OM Code consensus process, interactions with various technical organizations, user groups, and through periodic updates of NRC-published guidance and issuance of generic communications as the need arises. Revision 2 to NUREG-1482 incorporates regulatory guidance applicable to the 2004 Edition including 2005 and 2006 Addenda to the ASME OM Code. Revision 0 and Revision 1 to NUREG-1482 are still valid and may continue to be used by those licensees who have not been required to update their IST program to the 2004 Edition including the 2005 and 2006 Addenda (or later Edition) of the ASME OM Code. The guidance provided in many sections herein may be used for requesting relief from or alternatives to ASME OM Code requirements. However, licensees may also request relief or authorization of an alternative that is not in conformance with the guidance. In evaluating such requested relief or alternatives, the NRC uses the guidelines/recommendations of the NUREG, where applicable. The guidelines and recommendations provided in this NUREG and its Appendix A do not supersede the regulatory requirements specified in Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 50.55a, “Codes and standards”. Further, this NUREG does not authorize the use of alternatives to, grant relief from, the ASME OM Code requirements for inservice testing of pumps and valves, or inservice examination and testing of dynamic restraints (snubbers), incorporated by reference in 10 CFR 50.55a. Paper published with permission.
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