Actavis launches generic equivalent of long-acting ADHD drug, with 180-day exclusivity

FDA recently approved methylphenidate hydrochloride extended-release capsules (LA) CII, USP, the generic equivalent of Ritalin LA. Actavis Group, an international generic pharmaceuticals company, received first-to-file exclusivity on the 20-mg, 30-mg, and 40-mg strengths.

Distribution of the product has begun in the United States.
  
Methylphenidate hydrochloride extended-release capsules (20 mg, 30 mg, and 40 mg) had U.S. sales of approximately $80.7 million for the 12 months ending September 30, 2011, according to IMS Health.   
 
Doug Boothe, CEO of Actavis in the United States, said in a press release: “The approval and launch of methylphenidate hydrochloride extended-release capsules (LA) offers a significant value to our customers and patients. This approval, along with the first-to-file exclusivity, also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.”

Prescribing information is available at the Actavis website.