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Pharmaceutical Products with Device-Only Patents: A Cross-Sectional Analysis

Feldman WB, Teng TW, Kotrannavar S, Tu SS - Nature Biotechnology

  • Research Publications
| September 2026
  • Innovation Incentives and Competition

Summary:

Despite recent FTC enforcement, manufacturers continued to list “device-only” patents, which claim a product’s delivery device without mentioning its active ingredient, with the FDA for 55 products in 2026, including inhalers, intrauterine devices, and autoinjectors. The last-to-expire patents on 27 products (49%) were device-only, and these patents extended nominal protection by a median of 3.9 years beyond other patents. These findings highlight the potential impact of device patents on market competition for prescription drugs.

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The Impact of Semantics in Medicines Regulation

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

  • Commentary & Opinion
| October 2026
  • 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

  • Research Publications
| October 2026
  • 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

  • Commentary & Opinion
| September 2026
  • 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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