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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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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.

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