- •Authorized generics (AGs) are exact copies of a brand-name drug sold under the generic name by the brand-name manufacturer or its licensee.
- •In the case of entacapone, introduction of 4 AGs delayed independent generic competition, leading to an estimated $137 to $449 million in excess Medicare spending from 2011 to 2020.
- •Introduction of AGs in place of independent generics can reduce expected savings from generic competition.
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- Market exclusivity length for drugs with new generic or biosimilar competition, 2012-2018.Clin Pharmacol Ther. 2021; 109: 367-371
- Assessment of variation in state regulation of generic drug and interchangeable biologic substitutions.JAMA Intern Med. 2021; 181: 16-22
- Factors associated with generic drug uptake in the United States, 2012 to 2017.Value Health. 2021; 24: 804-811
- Prices of generic drugs associated with numbers of manufacturers.N Engl J Med. 2017; 377: 2597-2598
- Generic competition and drug prices: new evidence linking greater generic competition and lower generic drug prices. US Food and Drug Administration.https://www.fda.gov/media/133509/downloadDate accessed: June 13, 2022
- Office of generic drugs 2020 annual report: ensuring access to safe, effective, high-quality, and more affordable generic drugs. US Food and Drug Administration.https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2020-annual-reportDate accessed: September 22, 2021
- Authorized generics and their evolving role in prescription drug pricing and access.JAMA Intern Med. 2021; 321: 1563-1564
- Authorized generic drugs: short-term effects and long-term impact: a report of the Federal Trade Commission.(Federal Trade Commission.)https://www.ftc.gov/reports/authorized-generic-drugs-short-term-effects-long-term-impact-report-federal-trade-commissionDate accessed: April 12, 2022
- First Databank.https://www.fdbhealth.com/solutions/medknowledge-drug-databaseDate accessed: July 14, 2021
- Drug products in the Medicaid drug rebate program. Centers for Medicare & Medicaid Services.https://data.medicaid.gov/dataset/0ad65fe5-3ad3-5d79-a3f9-7893ded7963aDate accessed: April 12, 2021
- National drug code directory. US Food and Drug Administration.https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directoryDate accessed: March 7, 2022
- Marketing of first generic drugs approved by U.S. FDA from January 2010 to June 2017. US Food and Drug Administration.https://www.fda.gov/media/154101/downloadDate accessed: January 24, 2021
- Sandoz to license Orion Parkinson’s drug. The Pharma Letter.https://www.thepharmaletter.com/article/sandoz-to-license-orion-parkinson-s-drugDate accessed: April 19, 2022
- Tablet combining three Parkinson’s disease drugs within one being developed by Orion Pharma. Marketing agreement with Novartis. GlobeNewswire News Room.https://www.globenewswire.com/news-release/2000/09/07/1843178/0/en/Tablet-combining-three-Parkinson-s-Disease-drugs-within-one-being-developed-by-Orion-Pharma-Marketing-agreement-with-Novartis.htmlDate accessed: April 19, 2022
- 180-day generic drug exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. US Food and Drug Administration, Center for Drug Evaluation and Research.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/180-day-generic-drug-exclusivity-under-hatch-waxman-amendments-federal-food-drug-and-cosmetic-actDate accessed: April 5, 2020
- Medicare Part D Spending by Drug. Centers for Medicare and Medicaid Services.https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drugDate accessed: May 11, 2021
- US brand Rx net pricing tool. SSR Health.http://www.ssrhealth.com/us-brand-rx-net-price-tool/Date accessed: April 13, 2021
- A method for approximating future entry of generic drugs.Value Health. 2018; 21: 1382-1389
- Strategies that delay market entry of generic drugs.JAMA Intern Med. 2017; 177: 1665-1669
- US spending associated with transition from daily to 3-times-weekly glatiramer acetate.JAMA Intern Med. 2020; 180: 1165-1172
- Authorized generic drugs, price competition, and consumers’ welfare.Health Aff (Millwood). 2007; 26: 790-799
- FDA list of authorized generic drugs.(FDA.)https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugsDate accessed: April 16, 2022
- Overview of FTC actions in pharmaceutical products and distribution. Federal Trade Commission.https://www.ftc.gov/system/files/attachments/competition-policy-guidance/overview_pharma_june_2019.pdfDate accessed: June 14, 2022
- Confidentiality orders and public interest in drug and medical device litigation.JAMA Intern Med. 2020; 180: 292-299