• (PLX AI) – Lundbeck says U.S. District Court for the District of Delaware issued its decision upholding the validity of Lundbeck’s patent covering the active ingredient in Trintellix, vortioxetine, in patent litigation proceedings against six generic manufacturers.
  • • Lundbeck and its partner, Takeda, filed the infringement actions against the six generic manufacturers Alembic, Lupin, Macleods, Sandoz, Sigmapharm, and Zydus in response to their filing of Abbreviated New Drug Applications with the FDA seeking to obtain marketing approval for generic versions of vortioxetine in the U.S.
  • • The Court found that the ’884 Patent is valid, Lundbeck said
  • • The ’884 Patent expires on 17 June 2026, with an expected six-month pediatric exclusivity period extending to 17 December 2026
  • • Assuming the ruling is affirmed on potential appeal, final approval will not be granted to the relevant ANDAs until after expiration of the ’884 Patent, including any extensions or additional periods of exclusivity

Quelle: PLX AI