ANDA Filers Lose Again On Eliquis Patents With Monopoly Set For 2028
HEC’s Sunshine Lake Pharma, Sigmapharm and Unichem Fail On Appeal
ANDA filers that went to trial over Bristol Myers Squibb and Pfizer’s Eliquis blockbuster face a seven-year wait to launch their generic products after the US Court of Appeals for the Federal Circuit upheld a lower court decision.
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Japanese player Towa Pharmaceutical joined Sawai in capitalizing on Nichi-Iko’s misery by taking market share from its rival, as it ran factories at full capacity and plotted for further expansion.
Accord Healthcare is looking to breaking into the crowded market for biosimilar trastuzumab in the EU, after partner Henlius’ application was backed by the EMA’s CHMP. Meanwhile, a recommendation for a generic to the Eliquis anticoagulant was also forthcoming from the committee.
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.