Lundbeck says the U.S. District Court for Delaware issued its decision upholding the validity of the Danish company’s patent covering the active ingredient in Trintellix, vortioxetine, in litigation proceedings against six generic manufacturers.
- The court found that the ’884 Patent is valid; that patent expires on June 17, 2026, with an expected six-month pediatric exclusivity period extending to Dec. 17, 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,” Lundbeck says
- Court’s decision may be ...
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