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Piramal’s Sensipar Generic Is Blocked In The US

Executive Summary

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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Amneal And Amgen Dealt Same Sensipar Fate

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.

Amneal Suffers Setback On US Cinacalcet

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. 

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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.

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