Ranbaxy Laboratories Limited, along with its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc. (collectively, “Ranbaxy”), announced today that they have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Ranbaxy’s generic equivalent version of Actos (Pioglitazone Hydrochloride) 15 mg, 30 mg and 45 mg tablets. Under terms of the agreement, Takeda granted Ranbaxy a non-exclusive royalty free license to its U.S. patents covering Actos. Under the terms of the agreement, Ranbaxy has certainty in the launch of its generic equivalent formulation of Actos on August 17, 2012, or earlier under certain circumstances.
Actos had approximately $3.4 billion in brand sales for the twelve months ending December 31, 2009, according to IMS Health. Actos is a once-daily oral prescription medication that, with diet and exercise, has been shown to be effective for the treatment of type 2 diabetes.
“This agreement will allow RPI to bring to patients with diabetes a generic alternative in this important therapeutic area,” according to Jim Meehan, Vice President of Sales and Distribution for RPI.