Amneal Suffers Setback On US Cinacalcet
Non-Infringement Of Amgen Sensipar Formulation Patent Overturned
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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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.
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.