Watson seeks approval for generic ADHD treatment
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is seeking Food and Drug Administration approval for a generic treatment for attention deficit hyperactivity disorder, the company said.
Watson announced that it filed a regulatory approval application with the FDA for methylphenidate transdermal system, a patch designed to deliver the central nervous system stimulant methylphenidate over a nine-hour period. The drug is a generic version of Noven Pharmaceuticals' Daytrana.
Noven filed a patent infringement suit against Watson last week in the U.S. District Court for the District of New Jersey in response to the filing. Under the Hatch-Waxman Act, the suit puts a stay of FDA approval on Watson's drug for 30 months, or until the Noven and Watson settle the matter. Watson is likely the first company to file for approval of a generic version of Daytrana and as such, will have 180 days in which to compete directly with Noven once it wins final FDA approval.
Daytrana had sales of more than $87 million during the 12-month period ended in July, according to IMS Health.