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Research Letter
Health Care Policy and Law
March 29, 2021

Frequency of First Generic Drug Approvals With “Skinny Labels” in the United States

Author Affiliations
  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2021;181(7):995-997. doi:10.1001/jamainternmed.2021.0484

Brand-name drug manufacturers in the US use several strategies to delay generic competition,1 including obtaining a thicket of patents to protect beyond a drug’s active ingredient and original use.2 Such patents can cover use of the drug for supplemental indications that the US Food and Drug Administration (FDA) approves after a medication is already on the market.

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    1 Comment for this article
    FDA approved indication
    Linda Plizga, DO | Ascension St John Detroit
    Yes but if "skinny labels" don't include the indications then will they still be covered under insurance because then they won't be considered "FDA approved" for that indication?