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news.Cephalon, an international biopharmaceutical company, and Eurand, a specialty pharmaceutical company, have filed a lawsuit in US District Court of Delaware against Mylan Pharmaceuticals, Inc and its subsidiary, Mylan, Inc, and Barr Pharmaceuticals, Inc and its subsidiary, Barr Laboratories, Inc, for infringement of Eurand's US patent.
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This patent claims extended-release formulations containing the muscle relaxant cyclobenzaprine, including Amrix and expires February 26, 2025. The lawsuit is based upon abbreviated new drug applications (ANDA) filed by Mylan and Barr, each seeking the FDA approval for a generic equivalent of the 15mg and 30mg strengths of Amrix to be sold in the US.
The Mylan ANDA alleges that the Amrix patent will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or enforceability of the Amrix patent. The Barr ANDA alleges that the Amrix patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.
Amrix was previously approved by the FDA for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Eurand has developed Amrix based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of Amrix in the US. Concurrent with the patent protection, Cephalon has a three-year period of marketing exclusivity preventing the FDA approval of a generic version of Amrix until February 2010.