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Cephalon sues Mylan and Teva over key US Amrix patent

 
• By Nancy Faigen

Cephalonand Eurandhave filed suit in a US district court in Delaware against Barr PharmaceuticalsandMylan Laboratories, alleging patent infringement related to their generic versions of the muscle relaxant Amrex (cyclobenzaprine HCl) extended-release capsules, thus triggering the 30-month stays of approval while the legal challenge is fought. The brand companies claim infringement of Eurand's US patent covering the extended-release product, No 7,387,793, which is the only Orange Book-listed patent for the product, expiring in February 2025. Barr and Mylan have filed paragraph IV challenges to the patent, claiming that the patent is invalid, unenforceable and/or will not be infringed by its manufacture, and Mylan claims it has first-filer status.

Cephalonand Eurandhave filed suit in a US district court in Delaware against Barr PharmaceuticalsandMylan Laboratories, alleging patent infringement related to their generic versions of the muscle relaxant Amrex (cyclobenzaprine HCl) extended-release capsules, thus triggering the 30-month stays of approval while the legal challenge is fought. The brand companies claim infringement of Eurand's US patent covering the extended-release product, No 7,387,793, which is the only Orange Book-listed patent for the product, expiring in February 2025. Barr and Mylan have filed paragraph IV challenges to the patent, claiming that the patent is invalid, unenforceable and/or will not be infringed by its manufacture, and Mylan claims it has first-filer status.

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