First generic versions of Astellas’ Myrbetriq launched “at risk” in the US

2024-04-22

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The first generic versions of Astellas’ Myrbetriq (mirabegron) hit the market in the US, with 25mg doses of the overactive bladder treatment launched by Lupin and Zydus Lifesciences. The Japanese drugmaker said Monday it is reviewing the impact that the “at risk launch” will have on its financial forecasts.

The launches come after the US District Court for the District of Delaware recommended denying Astellas’ motion for a preliminary injunction against the generics from Lupin and Zydus pending patent litigation. In July last year, the Japanese firm filed a lawsuit claiming that the two generic versions of Myrbetriq infringe Patent No. 11,707,451.

Astellas indicated that it plans to file objections to the court’s recommendation, while it also has separate litigation against Lupin and Zydus in the US related to Patent No. 10,842,780; that case is currently pending at the Court of Appeals for the Federal Circuit.

Zydus said Monday that it is also prepared to launch its 50mg generic version of Myrbetriq “imminently.” Annual sales of Myrbetriq in the US stand at $2.4 billion, with around $1 billion of this generated by the 25mg dose.

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