Delivery Device Patents on GLP-1 Receptor Agonists

Alhiary R, Gabriele SME, Kesselheim AS, Tu SS, Feldman WB - JAMA

  • Innovation Incentives and Competition

Summary:

Dozens of delivery device patents were listed in the FDA Orange Book for glucagon like peptide-1 (GLP-1) receptor agonists despite none of these patents mentioning the drugs’ active ingredients, chemical structures, or therapeutic classes. These patents contribute to large patent thickets that serve as a basis for litigation against potential generic GLP-1 manufacturers and their removal would substantially reduce barriers to generic entry.

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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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