Delayed Generic Market Saturation After Patent Expiration—A Billion-Dollar Problem

Luo J, Kesselheim AS - JAMA Internal Medicine

  • Innovation Incentives and Competition

Summary:

In this invited commentary, the authors describe how brand-name manufacturers use strategies like authorized generics, formulary rebate contracts, and copay coupons to delay uptake of independent generics even after patent expiration. To address these practices, they propose various policy reforms, including FDA pre-approval of multiple generic manufacturers before patent expiry, temporary importation, and federal restrictions on coupon use when generics are available.

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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
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Delisted Patents on Pharmaceuticals, 1998-2024

Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
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Delays in Access to Generic Semaglutide Point to Key Missing Pieces in Canada’s Drug Approval System

Eisenkraft Klein D, Kesselheim AS - Health Policy

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Canada approved its first generic semaglutide nearly four months after market exclusivity expired, with delays arising from the absence of clear standards for demonstrating equivalence between fully synthetic generics and the brand-name product. Regulators should publish equivalence standards so manufacturers can build the required evidence into their initial submissions, helping lower-cost alternatives reach patients sooner.
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