Mylan introduces Cyclobenzaprine HCl ER Capsules, a muscle relaxant

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Cyclobenzaprine HCl ER Capsules and was awarded 180 days of marketing exclusivity.  

Cyclobenzaprine HCl ER Capsules are the generic version of Cephalon's Amrix® Capsules, a muscle relaxant. This product had U.S. sales of approximately $125 million for the 12 months ending March 31, 2011, according to IMS Health.

Currently, Mylan has 169 ANDAs pending FDA approval representing $100.7 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.