Orange Book Blog

In Re: Cyclobenzaprine Hyldrochloride Extended-Release Capsule Patent Litigation, No. 09-md-2118-SLR

Last Thursday, the U.S. District Court for the District of Delaware invalidated the asserted claims of two patents protecting Amrix (cyclobenzaprine), clearing the way for Mylan to launch its generic version (albeit at-risk).  On Friday, Mylan announced that it did just that, with 180-day exclusivity.

Today, Cephalon filed a Motion for a Temporary Restraining Order in the district court, aiming to enjoin Mylan's sales of generic Amrix.  Unfortunately, Cephalon's brief and supporting declarations were filed under seal, and are therefore not publicly available.  Cephalon presumably is asking the district court to halt Mylan's sales while it seeks an emergency stay of the district court decision in the Federal Circuit.

A TRO, however, is an extraordinary remedy.  And given that the district court did not seem to have any doubt of the invalidity of the asserted claims, it would be surprising if the TRO were granted.

UPDATE:  On May 16, Watson Pharmaceuticals announced that it launched an authorized generic version of Amrix, supplied by Cephalon's Anesta AG subsidiary.