Delisted Patents on Pharmaceuticals, 1998-2024

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.

Biologics account for more than half of US drug spending, yet US biosimilar uptake is about half that of the European Union. Three bipartisan bills could improve competition: the Biosimilar Red Tape Elimination Act would make all biosimilars interchangeable, the ETHIC Act would limit patent thickets and serial litigation, and the MAPI Act would require patent applicants to share relevant FDA information with the USPTO.