First US Eliquis Generics Face Six-Year Wait

Mylan And Micro Labs Have Settled With BMS Over Apixaban

 
• By Akriti Seth
  
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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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BMS expects its Eliquis exclusivity to fall in 2026 • Source: Shutterstock

Mylan and Micro Labs have received the first approvals from the US Food and Drug Administration for generic rivals to Bristol-Myers Squibb’s Eliquis (apixaban) 2.5mg and 5mg tablets. Janet Woodcock, director of the FDA’s center for drug evaluation and research, noted that the abbreviated new drug application approvals “mark the first generic approvals of a direct oral anticoagulant.”

However, patent-litigation settlement deals struck with the originator mean that BMS expects to maintain market exclusivity for the brand until...

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