FDA accepts Mylan's ANDA filing for generic Copaxone 40 mg/mL

Aug 28 2014

Mylan Inc. (Nasdaq: MYL) today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). This product is the generic version of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.

Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to IMS Health.

Currently, Mylan has 294 ANDAs pending FDA approval representing $105.7 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.