Company will have 180 days of marketing exclusivity
PITTSBURGH, May 13, 2011 /PRNewswire/ -- 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
SOURCE Mylan Inc.