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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

Executive Summary

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.

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Vortioxetine reaches the end of NCE term

Takeda’s Trintellix (vortioxetine hydrobromide) 5mg, 10mg and 20mg tablets lose their US new chemical entity (NCE) data exclusivity at the end of September 2018. Trintellix, first approved in September 2013 as Brintellix for treating acute major depressive disorder (MDD) in the US, is the first treatment for MDD approved by the US Food and Drug Administration (FDA). The brand-name change to Trintellix came into effect in May 2016 to decrease the risk of prescribing and dispensing errors due to name confusion with AstraZeneca’s antiplatelet drug Brilinta (ticagrelor).

Teva Leapfrogs Taro With Authorized Generic Epiduo Forte Launch

Teva has added another major dermatology brand to its armory, with the launch of an authorized generic version of Galderma’s Epiduo Forte Gel.

Amgen: We Expect To Double Biosimilar Sales By 2030

Amgen management paid close attention to the company’s biosimilar portfolio and pipeline during several recent calls with investors, including what differentiates the firm from its rivals in the biosimilars space.


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