Approximating Future Generic Entry for New Drugs

S. Kaplan , “F.D.A. Approves Gen–eric EpiPen that May Be Cheaper,” New York Times, August 16, 2018, available at <https://www.nytimes.com/2018/08/16/health/epipen-generic-drug-prices.html> (last visited February 22, 2019); C.V. Dave, A.S. Kesselheim, E.R. Fox, P. Qiu, A. Hartzema, “High Generic Drug Prices and Market Competition: A Retrospective Cohort Study,” Annals of Internal Medicine 167, no. 3 (2017): 145-151; A.S. Kesselheim, J. Avorn, A. Sarpatwari, “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858-871.

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A.S. Kesselheim , J. Avorn , and A. Sarpatwari , “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858-871.

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K. Vokinger , A.S. Kesselheim , J. Avorn , and A. Sarpatwari , “Strategies that Delay Market Entry of Generic Drugs,” JAMA Internal Medicine 177, no. 11 (2017):1665-1669; A.S. Kesselheim, M.S. Sinha, and J. Avorn, “Determinants of Market Exclusivity for Prescription Drugs in the United States,” JAMA Internal Medicine 177, no. 11 (2017): 1658-1664.

See Kesselheim, Sinha, and Avorn, id.

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A.S. Kesselheim , J.J. Gagne , W. Eddings , et al., “Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey,” JAMA Internal Medicine 176, no. 6 (2016): 845-847.

R.F. Beall , J.J. Darrow , and A.S. Kesselheim , “A Method for Approximating Future Entry of Generic Drugs,” Value in Health 21, no. 12 (2018): 1382-1389.

21 U.S.C. s 156 (2018); see also M.K. Dunn , “Timing of Patent Filing and Market Exclusivity,” Nature Reviews Drug Discovery 10, no. 7 (2011): 487-488; G.J. Mossinghoff, “Overview of the Hatch-Waxman Act and its Impact on the Drug Development Process,” Food and Drug Law Journal 54, no. 2 (1999): 187-194; A.D. Lourie, “Patent Term Restoration: History, Summary, and Appraisal,” Food Drug Cosmetic Law Journal 40 (1985): 351-362.

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See Beall, supra note 10.

See supra note 5; R.F. Beall and A.S. Kesselheim , “Tertiary Patenting on Drug–Device Combination Products in the United States,” Nature Biotechnology 36, 2 (2018): 142-145.

United States Food and Drug Administration, Drugs@FDA: FDA Approved Drug Products (2018), available at <https://www.accessdata.fda.gov/scripts/cder/daf/> (last visited February 22, 2019).

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United States Food and Drug Administration, National Drug Code Directory (2018), available at <https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm> (last visited February 22, 2019).

See Beall, supra note 10.

United States Patent and Trademark Office, Patent Terms Extended Under 35 USC §156 (2018), available at <https://www.uspto.gov/patent/laws-and-regulations/patent-term-extension/patent-terms-extended-under-35-usc-156> (last visited February 22, 2019).

See Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, supra note 15.

See Beall, supra note 7.

See Beall, supra note 7; see Hemphill, supra note 8.

See Beall, supra note 10.

Patents and Exclusivity 2015, supra note 12.

Kesselheim, Sinha, and Avorn, supra note 5.

Beall, supra note 10.

Pediatric Exclusivity Granted, supra note 12.

Patents and Exclusivity, supra note 12.

A. Sarpatwari , R.F. Beall , A. Abdurrob , M. He , and A.S. Kesselheim , “Evaluating the Impact of the Orphan Drug Act's Seven-Year Market Exclusivity Period,” Health Affairs 37, no. 5 (2018): 732-737.

A.W. Mulcahy , Z. Predmore , and S. Mattke , “The Cost Savings Potential of Biosimilar Drugs in the United States,” RAND Corporation Perspective (2014), available at <https://pdfs.semantic-scholar.org/42d0/665cb73c416ad0124d3b477ab199a4f165b0.pdf> (last visited March 8, 2019).

Vokinger, Kesselheim, Avorn, and Sarpatwari, supra note 5; Beall and Kesselheim, supra note 14.

Vokinger, Kesselheim, Avorn, and Sarpatwari, supra note 5.

A.S. Kesselheim , L. Murtagh , M.M. Mello , “‘Pay for Delay’ Settlements of Disputes over Pharmaceutical Patents,” New England Journal of Medicine 365, no. 15 (2011): 1439-1445; A.S. Kesselheim and J.J. Darrow, “Hatch-Waxman Turns Thirty: Do We Need a Redesigned Approach for the Modern Era?” Yale Journal of Health Policy Law & Ethics 15, no. 2 (2015): 293-348.

J.J. Darrow , R.F. Beall , and A.S. Kesselheim , “The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents,” Applied Health Economics and Health Policy 17, no. 1 (2018): 47-54.

United States Food and Drug Administration, List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (2018), available at <https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM564441.pdf> (last visited February 22, 2019).