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PITTSBURGH — Mylan Inc. has launched dexmethylphenidate hydrochloride extended-release capsules (30 mg), a medication for attention deficit hyperactivity disorder (ADHD).
The company said Monday that the product, launched by its Mylan Pharmaceuticals Inc. subsidiary, is the first generic version of Novartis’ Focalin XR.
Mylan reported that it’s the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for dexmethylphenidate hydrochloride ER capsules (30 mg). The company said it has received final approval from the Food and Drug Administration for its ANDA for the product and was awarded 180 days of marketing exclusivity.
Dexmethylphenidate hydrochloride ER capsules (30 mg) had U.S. sales of approximately $67.34 million for the 12 months ended Sept. 30.
The medication is a central nervous system stimulant indicated for the treatment of ADHD in patients age 6 years and older.
