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Approximating Future Generic Entry for New Drugs

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Columns: Health Policy Portal
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Kaplan, S., “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.+(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.>Google Scholar
Bender, B.G. and Rand, C., “Medication Non-Adherence and Asthma Treatment Cost,” Current Opinion in Allergy and Clinical Immunology 4, no. 3 (2004): 191-195; B.A. Briesacher, J.H. Gurwitz, and S.B. Soumerai, “Patients At-Risk for Cost-Related Medication Nonadherence: A Review of the Literature,” Journal of General Internal Medicine 22, no. 6 (2007): 864-871; M.T. Brown and J.K. Bussell, “Medication Adherence: WHO Cares?” Mayo Clinic Proceedings 86, no. 4 (2011): 304-314; N.K. Choudhry, J. Avorn, R.J. Glynn, E.M. Antman, S. Schneeweiss, M. Toscano, et al., “Full Coverage for Preventive Medications after Myocardial Infarction,” New England Journal of Medicine 365, no. 22 (2011): 2088-2097; N.K. Choudhry, T.D. Denberg, and A. Qaseem, “Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities from the Greater use of Generic Medications: Best Practice Advice from the Clinical Guidelines Committee of the American College of Physicians,” Annals of Internal Medicine 164, no. 1 (2016): 41-49.CrossRefGoogle Scholar
Kesselheim, A.S., Avorn, J., and Sarpatwari, A., “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858-871.Google Scholar
Hering, S., Loretz, B., Friedli, T., Lehr, C-M., and Stieneker, F., “Can Lifecycle Management Safeguard Innovation in the Pharmaceutical Industry?” Drug Discovery Today 23, no. 12 (2018): 1962-1973.CrossRefGoogle Scholar
Vokinger, K., Kesselheim, A.S., Avorn, J., and Sarpatwari, A., “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.CrossRefGoogle Scholar
See Kesselheim, Sinha, and Avorn, id.Google Scholar
Beall, R.F., Darrow, J.J., and Kesselheim, A.S., “Patent Term Restoration for Top-Selling Drugs in the United States,” Drug Discovery Today 24, no. 1 (2018): 20-25.CrossRefGoogle Scholar
Hemphill, C.S. and Sampat, B.N., “Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals,” Journal of Health Economics 31, no. 2 (2012): 327-339.CrossRefGoogle Scholar
Kesselheim, A.S., Gagne, J.J., Eddings, W., 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.CrossRefGoogle Scholar
Beall, R.F., Darrow, J.J., and Kesselheim, A.S., “A Method for Approximating Future Entry of Generic Drugs,” Value in Health 21, no. 12 (2018): 1382-1389.CrossRefGoogle Scholar
21 U.S.C. s 156 (2018); see also Dunn, M.K., “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.CrossRefGoogle Scholar
United States Food and Drug Administration, Pediatric Exclusivity Granted (2018), available at <https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm> (last visited February 22, 2019); United States Food and Drug Administration, Patents and Exclusivity (2015), available at <https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf> (last visited February 22, 2019).+(last+visited+February+22,+2019);+United+States+Food+and+Drug+Administration,+Patents+and+Exclusivity+(2015),+available+at++(last+visited+February+22,+2019).>Google Scholar
See Beall, supra note 10.Google Scholar
See supra note 5; Beall, R.F. and Kesselheim, A.S., “Tertiary Patenting on Drug–Device Combination Products in the United States,” Nature Biotechnology 36, 2 (2018): 142-145.CrossRefGoogle Scholar
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).+(last+visited+February+22,+2019).>Google Scholar
United States Food and Drug Administration, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (2018), available at <https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm> (last visited February 22, 2019).+(last+visited+February+22,+2019).>Google Scholar
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).+(last+visited+February+22,+2019).>Google Scholar
See Beall, supra note 10.Google Scholar
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).+(last+visited+February+22,+2019).>Google Scholar
See Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, supra note 15.Google Scholar
See Beall, supra note 7.Google Scholar
See Beall, supra note 7; see Hemphill, supra note 8.Google Scholar
See Beall, supra note 10.Google Scholar
Patents and Exclusivity 2015, supra note 12.CrossRefGoogle Scholar
Kesselheim, Sinha, and Avorn, supra note 5.Google Scholar
Beall, supra note 10.Google Scholar
Pediatric Exclusivity Granted, supra note 12.Google Scholar
Patents and Exclusivity, supra note 12.Google Scholar
Sarpatwari, A., Beall, R.F., Abdurrob, A., He, M., and Kesselheim, A.S., “Evaluating the Impact of the Orphan Drug Act's Seven-Year Market Exclusivity Period,” Health Affairs 37, no. 5 (2018): 732-737.CrossRefGoogle Scholar
Mulcahy, A.W., Predmore, Z., and Mattke, S., “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).Google Scholar
Vokinger, Kesselheim, Avorn, and Sarpatwari, supra note 5; Beall and Kesselheim, supra note 14.Google Scholar
Vokinger, Kesselheim, Avorn, and Sarpatwari, supra note 5.Google Scholar
Kesselheim, A.S., Murtagh, L., Mello, M.M., “‘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.CrossRefGoogle Scholar
Darrow, J.J., Beall, R.F., and Kesselheim, A.S., “The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents,” Applied Health Economics and Health Policy 17, no. 1 (2018): 47-54.Google Scholar
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).+(last+visited+February+22,+2019).>Google Scholar