From Cabozantinib to Zanzalintinib: Obvious Chemical Modifications as a New Frontier in Product Hopping

Strohbehn GW, Tu SS, Wang X, Ratain MJ - Nature Biotechnology

  • Innovation Incentives and Competition

Summary:

Exelixis’ development of zanzalintinib, a chemically modified successor to its blockbuster drug cabozantinib (Cabometyx, Cometriq), illustrates how obvious covalent changes to an active ingredient can secure a new composition-of-matter patent and extend market exclusivity ahead of a patent cliff. Lead compound analysis indicates zanzalintinib was legally obvious over cabozantinib, pointing to a need for stronger USPTO-FDA coordination in patent examination to better capture this novel form of product hopping.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

The Impact of Semantics in Medicines Regulation

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

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

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
Talk bubble graphics representing commentary and opinion.

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.
View Source