Mylan Launches Generic Focalin XR Capsules, 30 Mg - Quick Facts

(RTTNews) - Generic drugmaker Mylan Inc. (MYL) Monday said its subsidiary Mylan Pharmaceuticals Inc. has launched Dexmethylphenidate Hydrochloride Extended-release ER capsules, 30 mg, the first generic version of Novartis' Focalin XR.

This product is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder in patients age 6 years and older.

Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV patent certification for Dexmethylphenidate Hydrochloride ER Capsules, 30 mg.

The company received final approval from the U.S. Food and Drug Administration for its ANDA for this product and was awarded 180 days of marketing exclusivity.

According to IMS Health, Dexmethylphenidate Hydrochloride ER Capsules, 30 mg, had U.S. sales of $67.34 million for the 12 months ended September 30.

Currently, Mylan has 179 ANDAs pending FDA approval representing $90.5 billion in annual sales, according to IMS Health.

Forty of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ended June 30, according to IMS Health.