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ANDA Sponsors Fail To Knock Out Trintellix Active Ingredient Patent

IP Expiring In June 2026 Upheld As Valid By US District Court

 
• By Dean Rudge

Danish originator Lundbeck says it is “unthinkable” that proposed generic versions of its Trintellix treatment for major depressive disorder will find a way to the US market before 2027 following a US district court decision.

Gavel
Trintellix was the first treatment for acute major depressive disorder approved by the FDA • Source: Shutterstock

Abbreviated new drug application sponsors including Lupin Limited and Sandoz Inc. have received a setback in their efforts to launch ahead of patent expiry their generic versions of Takeda and Lundbeck’s Trintellix (vortioxetine) landmark treatment for acute major depressive disorder, with a mixed US district court decision.

In total, six ANDA sponsors – Alembic, Lupin, Macleods, Sandoz, Sigmapharm, and Zydus Cadila – were involved in patent litigation...

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