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Trio Face 11 Year Wait On Eliquis As US Patents Upheld

Key Formulation Patent Stands Strong Against Attack From Three Firms

 
• By Dean Rudge

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

Gavel
Sunshine Lake, Sigmapharm and Unichem went against the groove in taking their cases to trial • Source: Shutterstock

HEC’s Sunshine Lake Pharma, Sigmapharm and Unichem may have to wait until 2031 to launch generic versions of Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban) blockbuster in the US, after failing to obtain from a US district court either a finding of invalidity or non-infringement against the two Orange Book-listed patents shielding the blood thinner.

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