Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding

Barenie RE, Darrow JJ, Avorn J, Kesselheim AS - Neurology

  • Innovation Incentives and Competition

Summary:

Pregabalin (Lyrica) was discovered primarily through publicly funded research at Northwestern University before being licensed to Parke-Davis in 1990 for further development through its 2004 FDA approval. The study identified $13.8 million in related NIH funding across 37 awards during the drug’s preapproval period, underscoring the significant public-sector contribution to the development of this blockbuster medication.

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Recent Work from PORTAL

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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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