The company reports this to be the first 30 mg generic version of Novartis’ Focalin XR (dexmethylphenidate hydrochloride ER). Mylan was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for the 30 mg dose of dexmethylphenidate hydrochloride ER capsules. The company received final approval from the US Food and Drug Administration (FDA) for its ANDA and was awarded 180-days marketing exclusivity as the ‘first-to-file’ for the 30 mg dose.

Dexmethylphenidate hydrochloride is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older. According to IMS Health, the 30 mg dose of dexmethylphenidate hydrochloride ER capsules had US sales of approximately US$67.34 million for the 12 months ending 30 September 2013.

Generics rival Teva Pharmaceutical Industries (Teva) already has FDA approval for lower doses of its generic dexmethylphenidate hydrochloride ER capsules (5, 10 and 20 mg) and on 19 November 2013 received approval for a 40 mg dose of the drug. Teva has also received tentative FDA approval for 15, 25 and 35 mg versions of the drug.

Currently, Mylan has 179 ANDAs pending FDA approval representing US$90.5 billion in annual sales; 40 of these pending ANDAs are potential first-to-file opportunities, representing US$24.1 billion in annual brand-name sales, for the 12 months ending 30 June 2013, according to IMS Health.

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