Piramal’s Sensipar Generic Is Blocked In The US
Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.
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Generics players circled around Amgen’s $1.4bn Sensipar brand, filing ANDA products they believed did not meet the claim limitations of the originator’s formulation patent expiring in 2026. A US Court of Appeals handed out a mixed judgment in January this year, leading Amgen and ANDA filer Amneal to petition their respective decisions for rehearings, which have now received a response.
The US Court Of Appeals has told a Delaware district court to think again on whether Amneal’s generic cinacalcet formulation infringes Amgen’s Sensipar formulation patent. The court also said Zydus Cadila infringed, but Piramal did not.
Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.