Mexican Court Revives Denosumab Patent, Extends Amgen Exclusivity to 2027

Industry groups say the ruling jeopardizes biosimilar availability, injecting uncertainty into the 2027–2028 public purchase cycle.

Overview

On January 22, a collegiate administrative court granted Amgen an amparo that extends market exclusivity for Denosumab to 2027 despite the drug’s patent expiring in 2022.
COFEPRIS had already issued registrations for Denosumab biosimilars, and IMPI opposed reactivating the expired patent, positions industry groups say the court did not weigh sufficiently.
ANAFAM warns the decision undermines legal certainty, investment and the right to health, and it has sought meetings with the health minister, the IMPI chief and a presidential economic adviser.
A 24 Horas column reports ANAFAM, with IMPI support, will take the case to a judicial discipline tribunal to outline its effects on companies preparing to supply the public sector.
Biosimilar makers including Sandoz and Abbott say they are ready for the 2027–2028 consolidated purchase, while Amgen holds a 2025–2026 public contract worth 1.9 billion pesos and the ruling’s full text is not yet public, with reversibility described as limited.