Sandoz Defeat On Amgen’s Otezla Pushes US Generic Opportunity Back To 2028
Zydus Cadila Also On Receiving End Of Unfavorable Ruling
Amgen is set to enjoy its monopoly on the Otezla oral treatment for plaque psoriasis until late into the decade, after ANDA sponsors Sandoz and Zydus Cadila failed to find a way around the originator’s intellectual property, including a key patent expiring early in 2028.
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In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.
Amgen sees opportunity to grow Otezla sales through new indications and additional ex-US launches. The deal depends on Bristol closing its Celgene acquisition, pending FTC clearance.
In a blow to potential US generic competition, Zydus Cadila has withdrawn its appeal to an unfavorable federal ruling involving a US Farxiga (dapagliflozin) patent.