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As Bristol-Myers, Pfizer battle copycat challengers in court, FDA approves generics for blockbuster

Eliquis, the blockbuster blood thinner that has been a leading fixture in Bristol-Myers’ top line for years, now has FDA approved copycats.

Sold by an alliance between Bristol and Pfizer, the drug has generated at least a billion dollars in annual sales since 2014 and has kept growing: In the first nine months of 2019, it raked in nearly $5.9 billion in sales, surpassing the $5.4 generated by Bristol’s pioneering checkpoint inhibitor Opdivo.

The partners, akin to rivals J&J and Bayer and their anticoagulant Xarelto, have been working on expanding Eliquis’ reach. At ASH, data from a real-world study showed Eliquis was associated with lower rates of major bleeding, clinically-relevant non-major bleeding and recurrent venous thromboembolism (VTE) in patients with active cancer (cancer patients carry a high risk for developing blood clots).

The copycat approvals were granted to Micro Labs and Mylan Pharmaceuticals — but when they will hit the market is unclear.

The manufacturers of the branded version are currently battling patent challenges by a plethora of generic drugmakers in court. Eliquis is protected by three patents. One ran out on December 22 of this year — the other two are years away: November 21, 2026, and February 24, 2031. Last year, Aurobindo Pharma was granted tentative approval for its Eliquis generic.

Eliquis, known chemically as apixaban, is currently approved to dimish the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, as well as prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery; in addition, to treat DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

Written by: Natalie Grover

Published on: December 24, 2019, 06:07 AM EST

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