Journal articles: 'Market exclusivity'

1

Luchetti, Cynthia. "Market Exclusivity Strategies for Pharmaceuticals." Pharmaceutical Medicine 23, no. 2 (April 2009): 77–84. http://dx.doi.org/10.1007/bf03256753.

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Downing, Nicholas S. "Market Exclusivity for Top-Selling Pharmaceuticals." JAMA Internal Medicine 175, no. 4 (April 1, 2015): 637. http://dx.doi.org/10.1001/jamainternmed.2014.7972.

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Grootendorst, Paul, Minsup Shim, Adam Falconi, Tyler Robinson, and Joel Lexchin. "Intellectual Property Protection and Drug Plan Coverage: Evidence From Ontario." International Journal of Health Services 48, no. 4 (July 24, 2018): 702–15. http://dx.doi.org/10.1177/0020731418789610.

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Canada has strengthened intellectual property (IP) protections for pharmaceutical drugs several times over the last 3 decades. This study investigates whether the IP changes had an effect on the market exclusivity time of brand products on the Ontario Drug Benefit (ODB) formulary. We constructed a database that included the first brand approval date for drugs launched between 1974 and 2012, the first ODB listing date of the brand drug, and the first ODB listing date of the generic form of the drug. We then calculated the time of formulary exclusivity to detect any changes in market exclusivity times associated with changes to Canada’s IP regimen. There were 595 drugs launched between 1974 and 2012 that were available for analysis. Exclusivity gradually declined from the late 1970s to 1990. Drugs approved in 2004 received 7.6 years of exclusivity, and drugs approved in 2005 received 5 years of exclusivity. Over the time period we analyzed, market exclusivity time of brand drugs experienced marked changes, but we did not detect any systematic effects of Canada’s stronger pharmaceutical IP laws on the market exclusivity.

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Dunn, Michael K. "Timing of patent filing and market exclusivity." Nature Reviews Drug Discovery 10, no. 7 (July 2011): 487–88. http://dx.doi.org/10.1038/nrd3494.

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Goldman, Dana P., Darius N. Lakdawalla, and Tomas J. Philipson. "Market Exclusivity For Drugs: The Authors Reply." Health Affairs 30, no. 4 (April 2011): 799. http://dx.doi.org/10.1377/hlthaff.2011.0308.

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Argenton, Cédric, and Bert Willems. "Exclusivity Contracts, Insurance and Financial Market Foreclosure." Journal of Industrial Economics 60, no. 4 (December 2012): 609–30. http://dx.doi.org/10.1111/joie.12000.

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Kesselheim, Aaron S. "Adalimumab Pricing and Market Exclusivity for Biologics." New England Journal of Medicine 363, no. 24 (December 9, 2010): 2374. http://dx.doi.org/10.1056/nejmc1012150.

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Chirieac Roxana Maria. "Considerations on exclusivity clauses." Technium Social Sciences Journal 14 (December 10, 2020): 286–92. http://dx.doi.org/10.47577/tssj.v14i1.2229.

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In the context of internet sales can we still speak about a traditional exclusivity clause inserted in commercial contracts? As a market development, we can see that even without the COVID 19 pandemic, Internet sales were boosted all over the world. With international actors such as Amazon, JD.com Inc., E-bay or Apple as well as many others, we have seen ecommerce sale rise up to 3.46 trillion US dollars in 2019 alone. Even if these sales only amount to 16.4% of global sales, according to digital commerce specialists, the numbers will be much higher during and post pandemic. This being said, is there any place left for traditional exclusivity clauses inserted in many commercial contracts such as franchise, distribution or agency contracts? What will happen with specific clauses that grant one of the parties the right to an exclusive use of a territory or the right to address a certain population? During the years, doctrine as well as jurisprudence has shown that exclusivity clauses must be drafted with balance; the risk is huge in the sense that it might restrict the free access to the market, offer clients products that are of lesser quality or lead to a stranglehold of the market. On the other hand, the use of contracts that contain exclusivity clauses might become irrelevant for the beneficiary as they will no longer offer the protection and specific interest. The study aims to analyse exclusivity clauses as defined in the national and international regulations as well as study the current framework and the jurisprudence’s position on exclusivity clauses, especially the ones related to e-commerce.

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Ashoori, Minoo, Eric Schmidbauer, and Axel Stock. "Exclusivity as a Signal of Quality in a Market with Word-of-Mouth Communication." Review of Marketing Science 18, no. 1 (August 19, 2020): 99–115. http://dx.doi.org/10.1515/roms-2020-0022.

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AbstractIn some markets consumers seek exclusive consumption experiences, yet in these markets businesses sometimes market their goods widely and at low prices during an introduction period. We use a two-period game-theoretic model to provide a signaling explanation for this phenomenon. In our model, exclusivity-seeking consumers must infer product quality from its price and level of exclusivity in the initial stage. After purchase consumers communicate the true learned quality through word-of-mouth (WOM) so that the entire market becomes informed, including a group of new consumers whose size depends on the number of introductory purchasers and the strength of WOM. We show that a high-quality seller signals by marketing widely when the desire for exclusivity is intermediate and WOM is strong.

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Kesselheim, Aaron S. "Using Market-Exclusivity Incentives to Promote Pharmaceutical Innovation." New England Journal of Medicine 363, no. 19 (November 4, 2010): 1855–62. http://dx.doi.org/10.1056/nejmhle1002961.

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Ragavan, Srividhya. "Data exclusivity: a tool to sustain market monopoly." Jindal Global Law Review 8, no. 2 (October 2017): 241–60. http://dx.doi.org/10.1007/s41020-017-0050-2.

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12

Sheridan, Cormac. "EU to review rare disease drugs market exclusivity." Nature Biotechnology 22, no. 9 (August 27, 2004): 1061. http://dx.doi.org/10.1038/nbt0904-1061.

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Grabowski, Henry G., and Margaret Kyle. "Generic competition and market exclusivity periods in pharmaceuticals." Managerial and Decision Economics 28, no. 4-5 (2007): 491–502. http://dx.doi.org/10.1002/mde.1356.

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14

Son, Kyung-Bok, SeungJin Bae, and Tae-Jin Lee. "Does the Patent Linkage System Prolong Effective Market Exclusivity? Recent Evidence From the Korea-U.S. Free Trade Agreement in Korea." International Journal of Health Services 49, no. 2 (January 9, 2019): 306–21. http://dx.doi.org/10.1177/0020731418822237.

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This study evaluated the effect of the patent linkage system, fully introduced by the Korea-U.S. Free Trade Agreement in 2015, on patent challenges and the effective market exclusivity of new medicines in Korea. We used pharmaceutical approval data and pharmaceutical litigation data to detect new medicines and their counterparts, to collect patent challenges against new medicines, and to calculate effective market exclusivity for new medicines. Then, a nonparametric event history model was applied to statistically explain the duration of the market exclusivity of new medicines. Between 2007 and 2011, a total of 94 new medicines, consisting of 82 new chemical entities and 12 new biologics, were approved. The patent linkage system encouraged patent litigations to occur sooner, with a race to challenge the patents by various generic applicants. However, it was difficult to conclude that patent challenges had a significant impact on the prolongation of effective market exclusivity. The patent linkage system had a neutral effect on the effective market exclusivity of new medicines and encouraged patent challenges without abbreviating effective market exclusivity. In addition, this study highlights an important issue regarding biologics that has not been the subject of market competition, even for patent challenges.

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Morag-Sela, Tamar, Ilan Cohn, Thomas J. Kowalski, Judy Jarecki-Black, and Zoe Clyde-Watson. "Intellectual property law in Israel, and US and European objections: Market exclusivity vs. data exclusivity." Nature Biotechnology 22, no. 12 (December 2004): 1591–92. http://dx.doi.org/10.1038/nbt1204-1591.

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16

Li, Xiaolu. "Analysis of the Exclusivity of Hermès Handbags." BCP Business & Management 21 (July 20, 2022): 294–99. http://dx.doi.org/10.54691/bcpbm.v21i.1253.

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During the Covid-19 pandemic, the consumption and essentiality of luxury products have been affected by the economic recession. Hermès Handbags, being the main source of its revenue, did not decline, and even increased. The aim of this paper is to analysis the exclusivity of Hermès handbags as a key factor of its success. Through this analysis, the paper will also explain how Herne’s handbags endured the economic shocks. The main determinant market power of demand and supply on its pricing strategy in the luxury industry, and the impact of luxury goods on people’s lives will also be analyzed in by this paper. The involvement of luxury goods’ status representation, function, and aesthetic has profoundly influenced people’s consumption attitude in regard to luxury goods as a financial product for investment. This article will help in establishing what is important in increasing brand position and brand image in the market. Lastly this article will help hemes handbags become more competitive in the developing market economy.

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17

Rome, Benjamin N., and Aaron S. Kesselheim. "Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis." Clinical Infectious Diseases 71, no. 7 (October 20, 2019): 1671–75. http://dx.doi.org/10.1093/cid/ciz1039.

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Abstract Background To address the growing threat of multidrug-resistant organisms, policymakers are seeking ideas to promote development of novel antibiotics. In 2018, the REVAMP Act was proposed in Congress to reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers. Methods We estimated the economic impact of this proposal by identifying antimicrobial drugs approved by the FDA from 2007–2016 that would likely have qualified for an exclusivity voucher and matching each drug to the highest-revenue fast-track drug facing generic entry within 4 years after the antibiotic was approved. Assuming a spending decrease of 75% after generic entry, we calculated the per-drug and total societal costs of these transferrable market exclusivity extensions over a decade. Results We identified 10 antimicrobials that would have qualified for an exclusivity voucher, each of which was matched with 1 of 17 fast-track drugs facing generic entry through July 2019. These 10 drugs had a median annual revenue before generic entry of $249 million (range, $26 million–$2.7 billion). Accounting for a 75% spending reduction after generic entry, the median excess spending associated with 12 months of extended exclusivity was $187 million, for a total of $4.5 billion over 10 years. Conclusions While market exclusivity extensions are a politically appealing mechanism to encourage novel antibiotic development, this approach would cost public and private payers billions of dollars over the next decade.

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18

&NA;. "New legislation could see orphan drug market exclusivity reduced." Inpharma Weekly &NA;, no. 932 (April 1994): 22. http://dx.doi.org/10.2165/00128413-199409320-00059.

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19

Engelberg, Alfred B., Aaron S. Kesselheim, and Jerry Avorn. "Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics." New England Journal of Medicine 361, no. 20 (November 12, 2009): 1917–19. http://dx.doi.org/10.1056/nejmp0908496.

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20

Musselwhite, Laura, and Bryan Collingsworth. "Societal Impact Of Extending Market Exclusivity For Conventional Drugs." Health Affairs 30, no. 4 (April 2011): 798. http://dx.doi.org/10.1377/hlthaff.2011.0310.

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21

Socal, Mariana P., Sonal Parasrampuria, and Gerard F. Anderson. "Modifying the Criteria for Granting Orphan Drug Market Exclusivity." Value in Health 23, no. 11 (November 2020): 1470–76. http://dx.doi.org/10.1016/j.jval.2020.08.004.

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22

Sinha, Michael S., Gregory D. Curfman, and Michael A. Carrier. "Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry." JAMA 319, no. 22 (June 12, 2018): 2271. http://dx.doi.org/10.1001/jama.2018.3478.

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23

Apel, Brian. "An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the "Failure to Market" Provision of the Hatch-Waxman Act." Michigan Law Review, no. 114 (2015): 107. http://dx.doi.org/10.36644/mlr.114.1.administrative.

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Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created several statutory forfeiture provisions that proved only marginally effective at curbing the practice of exclusivity parking. More recently, Congress created new quasi-judicial administrative proceedings that effectively replace certain kinds of district court patent litigation. This Note describes the complex statutory scheme that gave rise to exclusivity parking, explains why previous and current attempts to curtail exclusivity parking were and remain ineffective, and suggests amending the “failure to market” provision to include these new administrative proceedings as a way to help curb exclusivity parking.

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24

Choi, Yong-Jae. "Exclusivity of Zero-rating Contracts in Competitive Internet Service Market." Information Society & Media 20, no. 2 (August 31, 2019): 101–22. http://dx.doi.org/10.52558/ism.2019.08.20.2.101.

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25

’t Hoen, Ellen. "Protect against market exclusivity in the fight against COVID-19." Nature Medicine 26, no. 6 (May 7, 2020): 813. http://dx.doi.org/10.1038/s41591-020-0876-6.

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26

Storz, Ulrich. "Extending the market exclusivity of therapeutic antibodies through dosage patents." mAbs 8, no. 5 (April 26, 2016): 841–47. http://dx.doi.org/10.1080/19420862.2016.1180491.

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27

Fisher, Dennis. "Do the Right Thing (or Do the Market Exclusivity Thing?)." Anesthesiology 105, no. 6 (December 1, 2006): 1074–75. http://dx.doi.org/10.1097/00000542-200612000-00003.

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28

Baker, Brook K. "Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage." American Journal of Law & Medicine 34, no. 2-3 (June 2008): 303–44. http://dx.doi.org/10.1177/009885880803400209.

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The pharmaceutical industry's dependence on intellectual property rights (IPRs), especially patents, to exclude competitors and thereby recoup past expenditures, incentivize future investments in research and development (R&D), and maximize profits is well known. Although initially content to solidify patent rights in the rich-country markets of North America, Europe, and Japan, in the last quarter of the 20th century the industry has increasingly turned its attention to emerging markets in Latin America, Asia, and even Africa as sites of future market expansion. Big middle-income countries like Brazil, India, China, and Indonesia have growing middle classes that increasingly favor allopathic medicine over the more traditional medicines of their elders. Obtaining monopoly rights in these growing markets could help the pharmaceutical industry weather the storm of increased consumer, business, and government blow-back against supra-competitive drug prices charged in rich country markets.

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29

Liang, Zhiwen. "Regulatory exclusivity protection for undisclosed test data in China: an innovative approach to implementing the TRIPS Agreement." Queen Mary Journal of Intellectual Property 10, no. 1 (February 19, 2020): 115–27. http://dx.doi.org/10.4337/qmjip.2020.01.05.

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Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.

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30

Gilchrist, Duncan S. "Patents as a Spur to Subsequent Innovation? Evidence from Pharmaceuticals." American Economic Journal: Applied Economics 8, no. 4 (October 1, 2016): 189–221. http://dx.doi.org/10.1257/app.20150373.

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This paper examines how an incumbent's patent protection acts as an implicit subsidy toward non-infringing substitutes. I analyze whether classes of pharmaceuticals whose first entrant has a longer period of market exclusivity (time between approval and generic entry) see more subsequent entry. Instrumenting for exclusivity using plausibly exogenous delays in the development process, I find that a one-year increase in the first entrant's market exclusivity increases subsequent entry by 0.2 drugs. The effect is stronger for subsequent entrants that are lesser clinical advances, suggesting it is driven primarily by imitation. (JEL K11, L65, O31, O34)

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Hugenholtz, P. Bernt, and Joost Poort. "Film Financing in the Digital Single Market: Challenges to Territoriality." IIC - International Review of Intellectual Property and Competition Law 51, no. 2 (December 17, 2019): 167–86. http://dx.doi.org/10.1007/s40319-019-00900-2.

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AbstractThis article discusses the role of territorial licences for feature films against the background of judicial and market developments in the EU. Currently, territorial licences are deemed a cornerstone of the exploitation and financing of films in Europe. However, current models of film financing are under increasing pressure both from market developments such as the turbulent growth of global online video platforms, and from developments in EU law aimed at removing national territorial barriers to the Single Market. Examples are the rule of Union-wide exhaustion of the distribution right, the EU Portability Regulation and the country of origin rules for satellite broadcasting and online simulcasting. EU competition law sets additional limits to grants of territorial exclusivity, and prohibits clauses in broadcasting and pay television licences that prevent or restrict “passive” sales to consumers/viewers in non-licensed territories. The freedom of right holders to preserve territorial exclusivity by way of contract is likely to become increasingly vulnerable to EU competition law, as underlying territorial rights no longer support territorial grants. For the film sector where territorial exclusivity remains indispensable, the European Commission could create specific competition law rules in the form of “block exemptions”. Language exclusivity – i.e. exclusive grants of rights for distinct language versions of a film – could provide a practical and legally more robust alternative to territorial licensing.

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32

Gersten, Judge David M. "The quest for market exclusivity in biotechnology: Navigating the patent minefield." NeuroRX 2, no. 4 (October 2005): 572–78. http://dx.doi.org/10.1602/neurorx.2.4.572.

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33

Glover, Gregory J. "The influence of market exclusivity on drug availability and medical innovations." AAPS Journal 9, no. 3 (September 2007): E312—E316. http://dx.doi.org/10.1208/aapsj0903034.

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34

Fernandez, Dennis S., and James T. Huie. "Balancing US patent and FDA approval processes: strategically optimizing market exclusivity." Drug Discovery Today 9, no. 12 (June 2004): 509–12. http://dx.doi.org/10.1016/s1359-6446(04)03067-3.

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35

Kesselheim, Aaron S., Michael S. Sinha, and Jerry Avorn. "Determinants of Market Exclusivity for Prescription Drugs in the United States." JAMA Internal Medicine 177, no. 11 (November 1, 2017): 1658. http://dx.doi.org/10.1001/jamainternmed.2017.4329.

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36

Park, H., and T. Lee. "Market Exclusivity Periods And Patent Challenges In Pharmaceuticals In South Korea." Value in Health 19, no. 7 (November 2016): A444. http://dx.doi.org/10.1016/j.jval.2016.09.565.

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37

Feldman, William B., Doni Bloomfield, Reed F. Beall, and Aaron S. Kesselheim. "Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD." Nature Biotechnology 40, no. 9 (September 2022): 1319–25. http://dx.doi.org/10.1038/s41587-022-01451-7.

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38

Maxwell, Claire. "Distinction, exclusivity and whiteness. Elite Nigerian parents and the international education market." British Journal of Sociology of Education 41, no. 2 (January 23, 2020): 269–71. http://dx.doi.org/10.1080/01425692.2020.1715550.

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39

Miller, Chris P. "Increasing Market Exclusivity for New Drugs, the Cure for What Ails Us?" ACS Medicinal Chemistry Letters 3, no. 6 (May 16, 2012): 437–39. http://dx.doi.org/10.1021/ml300111p.

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40

Wu, Wenxi, and Garth Stahl. "Distinction, exclusivity and whiteness: elite Nigerian parents and the international education market." Discourse: Studies in the Cultural Politics of Education 41, no. 3 (June 26, 2019): 497–500. http://dx.doi.org/10.1080/01596306.2019.1627756.

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Hermalin, Benjamin E., and Michael L. Katz. "Product Differentiation through Exclusivity: Is there a One-Market-Power-Rent Theorem?" Journal of Economics & Management Strategy 22, no. 1 (January 9, 2013): 1–27. http://dx.doi.org/10.1111/jems.12008.

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42

Kandel, M., A. Degrassat-Théas, O. Parent de Curzon, M. Sinègre, and P. Paubel. "Economic Impact of The End of The Market Exclusivity for Orphan Drugs." Value in Health 18, no. 7 (November 2015): A678. http://dx.doi.org/10.1016/j.jval.2015.09.2012.

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43

MAKSYMCHUK, Maksym. "INSTITUTIONAL BASIS OF EXCLUSIVITY OF REGIONAL DEVELOPMENT REGULATION." Ukrainian Journal of Applied Economics 5, no. 1 (March 1, 2020): 280–87. http://dx.doi.org/10.36887/2415-8453-2020-1-33.

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Introduction. Reforming the political-administrative system on the basis of decentralization significantly expands the range of subjects of policy making and decision-making, as the regional and local levels of the political process are strengthened. This makes it possible to involve citizens more widely in political decision-making. However, in this context there is a threat of forming separate regional and local "clusters". They will arbitrarily interpret the rules set by the central government. The institutional basis for the exclusivity of regional development regulation should be understood as a set of institutions, formal and informal rules of administrative and economic behavior of management and economic entities in the regions of the state, which impede access of all actors to economic development. The Purpose of this article is identifying the institutional factors of exclusive development of the regions of the state and substantiating the recommendations for improving the efficiency of regulatory processes on the basis of an inclusive model of regional development. Results. In the article the development peculiarities of the formation processes of the exclusion of the regional development regulation are analyzed. Problems related to the functioning of the institution of the administrative market are outlined. Recommendations for improving the efficiency of the regional governance system are substantiated and the prospects for its development in the context of the introduction of an inclusive model are identified. Conclusion. It is noted that the efficiency and reliability of the regional development regulation system depends on a number of institutional factors that should act in the direction of overcoming political and economic exclusion and the formation of inclusive governance institutions in the regions of Ukraine. This process requires the development of an overall strategy, the formation of which is greatly complicated by the transfer of some political processes to the regional and local levels. Keywords: institutional development, system with open and limited access, regional development regulation, exclusive and inclusive development, administrative market, administrative reform, decentralization, region, Ukraine.

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44

Son, Kyung-Bok. "Establishing healthy pharmaceutical regulations on statutory exclusivity: Lessons from the experience in the European Union, Canada, South Korea, Australia, and the United States." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 14, no. 4 (September 6, 2018): 167–74. http://dx.doi.org/10.1177/1741134318799385.

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Abstracts Objectives Recent international trade agreements require member countries a prolonged statutory exclusivity for biologics, and domestic legislation guarantees various forms of exclusivity for specific drugs, indications, or studies. This study notes prolonged exclusivity provisions for biologics in the United States and international trade agreements. We aim to review various exclusivity systems, including chemical entities, in selected high-income countries and to suggest implications for establishing the system specifically relevant for biologics in low- and middle-income countries. Methods We conducted a review of a comprehensive range of literature to develop the framework. Then, a comparative legal analysis was conducted to analyze the deviations among the systems in the European Union, Canada, South Korea, Australia, and the United States. Results There is constructive ambiguity in international trade agreements, specifically for provisions regarding biologics. Furthermore, the selected countries operate different statutory exclusivity systems in terms of eligibility for statutory exclusivity, specific measures for exclusivity, and other elements of exclusivity. In addition, market exclusivity, which is distinguished from data exclusivity, is not available in Korea and Australia. There are also various forms of statutory exclusivity for specific drugs, indications, or studies requested by the marketing authority. Conclusions Given constructive ambiguities in international agreements and variations in the manner of implementations of the systems in selected countries, statutory exclusivity for biologics could be established with cautions to mediate the harms. In this study, we suggest several solutions and alternatives for low- and middle-income countries.

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45

Lee, Robin S. "Vertical Integration and Exclusivity in Platform and Two-Sided Markets." American Economic Review 103, no. 7 (December 1, 2013): 2960–3000. http://dx.doi.org/10.1257/aer.103.7.2960.

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This paper measures the impact of vertically integrated and exclusive software on industry structure and welfare in the sixth-generation of the US video game industry (2000–2005). I specify and estimate a dynamic model of both consumer demand for hardware and software products, and software demand for hardware platforms. I use estimates to simulate market outcomes had platforms been unable to own or contract exclusively with software. Driven by increased software compatibility, hardware and software sales would have increased by 7 percent and 58 percent and consumer welfare by $1.5 billion. Gains would be realized only by the incumbent, suggesting exclusivity favored the entrant platforms. (JEL D12, L13, L22, L63, L86)

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Nagar, Sarosh, and Aaron S. Kesselheim. "Promoting Competition in Drug Pricing: A Review of Recent Congressional Legislation." Journal of Law, Medicine & Ethics 49, no. 4 (2021): 683–87. http://dx.doi.org/10.1017/jme.2021.93.

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AbstractBrand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

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47

Sarpatwari, Ameet, Reed F. Beall, Abdurrahman Abdurrob, Mengdong He, and Aaron S. Kesselheim. "Evaluating The Impact Of The Orphan Drug Act’s Seven-Year Market Exclusivity Period." Health Affairs 37, no. 5 (May 2018): 732–37. http://dx.doi.org/10.1377/hlthaff.2017.1179.

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48

Kerr, Kirk W., and Lukas J. Glos. "Effective Market Exclusivity of New Molecular Entities for Rare and Non-rare Diseases." Pharmaceutical Medicine 34, no. 1 (December 20, 2019): 19–29. http://dx.doi.org/10.1007/s40290-019-00317-9.

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49

Stoate, Nigel. "EU enlargement, the Bolar exemption and parallel imports: The consequences for market exclusivity." Journal of Medical Marketing 3, no. 3 (June 1, 2003): 239–44. http://dx.doi.org/10.1057/palgrave.jmm.5040126.

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50

Lexchin, Joel. "Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study." Value in Health 20, no. 8 (September 2017): 1139–42. http://dx.doi.org/10.1016/j.jval.2017.05.004.

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Journal articles on the topic 'Market exclusivity'

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