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news.Takeda and its wholly-owned subsidiary Takeda Pharmaceuticals North America have completed settlements with all defendants in patent litigation brought against the companies in response to their abbreviated new drug applications (ANDAs) for generic ACTOS (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl) and duetact (pioglitazone HCl and glimepiride).
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Takeda filed the lawsuits to enforce several patents that expire in 2016 relating to ACTOS, ACTOplus met, and duetact.
Agreements have been reached with: Mylan, Alphapharm, Watson Pharmaceuticals, Ranbaxy, Sandoz, Teva Pharmaceutical Industries, Torrent Pharmaceuticals, Dr Reddy’s, Wockhardt, Synthon Pharmaceuticals, Breckenridge Pharmaceutical (collectively, the Synthon defendants), and Aurobindo Pharma.
Based on these settlements, Takeda continues to operate in accordance with its Mid-Range Plan, announced in May 2010, which assumes that market entry of generic ACTOS will occur on 17 August 2012 and that market entry of generic ACTOplus met and generic duetact will occur on 14 December 2012.
Takeda is the inventor and developer of ACTOS, which was launched commercially in the US in 1999 for the treatment of type 2 diabetes.