Actavis commences distribution of Methylphenidate Hydrochloride Extended-Release Capsules

Actavis Group, an international generic pharmaceuticals company, today announced that it recently received approval from the US Food & Drug Administration to market Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII, USP, 20mg, 30mg, and 40mg.  Actavis has first-to-file exclusivity on the 20mg, 30mg, and 40mg strengths. Distribution of the product has commenced. 

Methylphenidate Hydrochloride Extended-Release Capsules 20mg, 30mg and 40mg, the generic equivalent of Ritalin LA® 20mg, 30mg, and 40mg, had US sales of approximately $80.7 million for the 12 months ending September 30, 2011, according to IMS Health.   

Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:

"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."