Lundbeck Pursues Brintellix Infringement Charges In India
Lundbeck seeks to ward off Alembic and Hetero over alleged patent infringing activity pertaining to its depression therapy vortioxetine in India. The product is seen as one of the key drivers of growth in 2021 for the Danish company, which has settled infringement proceedings with over half a dozen generic opponents so far in the US.
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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).
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A COVID-19 second wave is wreaking havoc in India but pharma appears to be holding things together for now, stretching resources amid a dip in personnel attendance and supply chain strains. Limited vaccine supplies, a spurt in API prices and an inevitable third wave could mean further turbulence ahead.