Watson Pharma sues FDA over generic Actos
PARSIPPANY, N.J. (AP) — Watson Pharmaceuticals Inc. said Wednesday that it is suing the Food and Drug Administration to gain approval of a generic version of the type 2 diabetes treatment Actos.
Watson wants the FDA to grant it shared marketing exclusivity for its generic version of Actos. That would keep most other versions off the market for 180 days, but Watson said the FDA won't grant it marketing exclusivity, which could keep Watson from selling its version of the drug until another company's generic has been on sale for 180 days. Watson wants to start selling its generic on Friday.
The company said it has followed the FDA's instructions and worked with the agency to resolve these issues. It said the FDA is creating an unnecessary delay in the approval. Watson said U.S. sales of Actos, or pioglitazone, totaled $2.7 billion over the 12 months ended May 31.
Actos is marketed by Takeda Pharmaceuticals of Japan. Under terms of a 2010 legal settlement between Watson and Takeda, Takeda licensed the U.S. patents to Watson and allowed it to start marketing a generic on Aug. 17, 2012. The patents supporting Actos expire in 2016.
Watson said that even if its generic Actos is not approved soon, it can still reach its full-year forecasts because of a positive FDA update related to another product and better market conditions for some other generic drugs in the U.S.
Shares of Watson Pharmaceuticals fell 45 cents to $79.73 in morning trading.
