Intercept sues Apotex over Ocaliva generic
Intercept Pharmaceuticals is suing Canadian generics manufacturer Apotex over a proposed version of autoimmune drug Ocaliva (obeticholic acid).
In a lawsuit filed at the US District Court for the District of Delaware last Friday, August 21, Intercept said Apotex’s abbreviated new drug application (ANDA) infringes four Ocaliva patents, the most recent of which was filed in 2017.
Ocaliva is used to treat primary biliary cholangitis, an autoimmune disease of the liver. It is used in combination with ursodeoxycholic acid (UDCA), or on its own for patients unable to tolerate UDCA.
Last month, Apotex notified Intercept that it had submitted an ANDA to the US Food and Drug Administration (FDA) for a generic version of Ocaliva.
Intercept claims the ANDA infringes US patents 9,238,673; 10,047,117; 10,052,337; and 10,174,073.
The company is seeking a permanent injunction, declaratory judgment that Apotex has infringed its patents, as well as damages and attorneys’ fees.
Apotex is Canada’s largest generics manufacturer, with annual sales of CAN$ 3 billion (US$ 2.281 billion).
Earlier this month, Apotex settled another patent dispute with Bayer over the Canadian company’s proposed generic of a cancer drug.
Apotex had informed the FDA of its desire to launch a generic version of Stivarga (regorafenib), prompting Bayer to sue.
And in January, the Canadian company suffered a defeat at the hands of Eli Lilly, who sued Apotex for infringing patents covering an injectable form of cancer drug Alimta (pemetrexed disodium).
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