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Cephalon wins injunction against Mylan

Cephalon has won a court restraining order in its efforts to keep Mylan Pharmaceuticals from selling a low-cost generic version of the extended-release muscle relaxant Amrix

Cephalon has won a court restraining order in its efforts to keep Mylan Pharmaceuticals from selling a low-cost generic version of the extended-release muscle relaxant Amrix (cyclobenzaprine hydrochloride).

The United States District Court for the District of Delaware has granted a temporary restraining order (TRO) requiring Mylan to resist from "manufacturing, using, offering to sell or selling its cyclobenzaprine hydrochloride extended-release capsules," according to Cephalon. 

The TRO follows a decision made in Mylan's favour by the same court earlier this month, and remains in effect pending Cephalon's planned appeal of that ruling.

"We are very pleased with the Court's decision to grant our request for a TRO," said Jerry Pappert, executive vice president and general counsel for Cephalon. "We remain confident in the strength of the patents protecting Amrix, and believe we have a strong case on appeal."

Cephalon and its partner Eurand filed their patent infringement lawsuit against Mylan, as well as a similar suit against Barr, in 2008 after both generic companies submitted abbreviated new drug applications (ANDAs) to the US Food and Drug Administration (FDA) for approval to sell generic equivalents of two strengths of Amrix. Mylan claimed that the patent would not be infringed, and Barr said the patent concerning Amrix is invalid.

Mylan announced earlier this month that it had launched its generic version of Amrix in the US following the court's decision in its favour, and said that it had been awarded 180 days of generic marketing exclusivity by the FDA for being the first company to submit a substantially complete ANDA for the product containing a challenge to Cephalon patent.

Amrix was developed by Eurand and is marketed in North America by Cephalon. In February 2007, the FDA approved two dosage strengths of the branded drug for short-term use, accompanied by rest and physical therapy, to treat muscle spasms associated with acute musculoskeletal conditions. Amrix had US sales of approximately $125m for the 12 months ending March 31, 2011, according to IMS Health.

23rd May 2011

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