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Amneal Suffers Setback On US Cinacalcet

Non-Infringement Of Amgen Sensipar Formulation Patent Overturned

Executive Summary

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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Amgen Fails To Block Cipla’s Generic Cinacalcet In US, And It May Change How Patent Settlements Are Drafted

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.

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.

Launch Abbreviated: Teva Halts US Generic Sensipar Sales After Patent Deal With Amgen

In the course of a week, Teva received final ANDA approval for cinacalcet, launched its generic and reached a deal with Amgen to come off the market until mid-2021. The fast but short launch allowed Teva to take some sales away from Amgen without triggering entry of other ANDA sponsors who previously settled, Bernstein Senior Analyst Ronny Gal says.

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