Piramal’s Sensipar Generic Blocked In US, For Now
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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Amgen is unlikely to succeed on the merits of its breach of contract claim, court says, concluding that Teva’s December launch of its noninfringing generic precludes the Sensipar marketer from seeking recovery for Cipla’s at-risk launch under the Amgen-Cipla settlement agreement.
Q1 revenue was roughly in line with expectations, but product sales were lower than consensus as multiple blockbusters faced generic competitors and biosimilars – a scenario the company prepared investors for earlier this year.
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.