Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Cephalon sues Mylan and Teva over key US Amrix patent

This article was originally published in Scrip

Executive Summary

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.



Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts