Watson Pharmaceuticals’ newly approved generic version of the type 2 diabetes drug Actos (pioglitazone) is now available in the United States, making Watson the second company to launch a generic version of Actos in the U.S. The other generic is made by Ranbaxy Laboratories and Teva Pharmaceuticals.
Actos is made by Japanese drug maker Takeda Pharmaceuticals. The patent for Actos expires in 2016; however, under the terms of a 2010 legal settlement, generic versions can be marketed as early as August 17, 2012.
Watson had originally made a bid to launch its generic drug in August but the Food and Drug Administration (FDA) failed to grant final approval. Watson sued the FDA for dragging its feet, and also hoped to gain marketing exclusivity, which would have granted it the right to be the only generic Actos on the market for 180 days.
After Watson sued, the drug company said Mylan Pharmaceuticals intervened as a defendant. On Monday, the U.S. District Court for the District of Columbia ruled in favor of Watson and ordered the FDA to approve Watson’s request. Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit, but the court denied Mylan’s motion to halt the judgment pending the appeal.
Actos is in a class of type 2 diabetes drugs known as thiazolidinediones, or TZDs, which also includes Avandia (rosiglitazone). In 2010, the FDA severely restricted the use of Avandia after it was linked to fatal heart attacks.
In 2011, the FDA issued a warning that studies showed Actos increased the risk for bladder cancer. Generic versions of Actos carry the same bladder cancer risk as the brand-name drug.
Source: CBS News