Breckenridge Pharmaceutical has announced that it and Synthon Pharmaceuticals have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving patent litigation related to Pioglitazone Hydrochloride 15 mg, 30 mg and 45 mg tablets, a generic equivalent version of Actos. Under the terms of the agreement, Takeda granted Breckenridge and Synthon a non-exclusive, royalty-free license to its U.S. patents covering Actos, permitting launch of their generic-equivalent formulation of Actos after first-filers of ANDAs with paragraph IV certifications exhaust their 180-day marketing exclusivity on February 13, 2013, or earlier under certain circumstances, subject to regulatory approval.
Breckenridge and Synthon signed a distribution and supply agreement on the product in late 2009 and have been working together on this product, including the settlement of the paragraph IV litigation.
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.