FDAnews Drug Daily Bulletin

BMS, Pfizer Challenge Zydus’ Eliquis Generic in Patent Suit

April 18, 2017

Pfizer and Bristol-Myers Squibb filed a patent infringement lawsuit against Zydus Pharmaceuticals over its proposed generic version of the blood thinner Eliquis.

In its ANDA, Zydus is seeking approval for 2.5 mg and 5 mg tablets of Eliquis (apixaban). Pfizer and BMS say the generic infringes on two patents covering the compounds and formulations of apixaban, granted in 2010 and 2016.

In its letter notifying the two companies of the ANDA filing, Zydus said the companies’ patents are invalid and unenforceable. The suit was filed in the U.S. District Court for the District of Delaware.

Eliquis, sponsored by BMS, is approved to reduce the risks of stroke and deep vein thrombosis. The blood thinner brought in over $3.3 billion in worldwide revenue last year — an 80 percent increase over 2015 — representing 17.2 percent of the company’s total.

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