Trio Face 11 Year Wait On Eliquis As US Patents Upheld
Key Formulation Patent Stands Strong Against Attack From Three Firms
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.
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Mylan and Micro Labs have received the first FDA approvals for generic rivals to BMS’ Eliquis oral anticoagulant. However, as a result of the firms’ settlements with the originator, BMS does not expect the generics to hit the US market until 2026.
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