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news.Takeda Pharmaceutical (Takeda) and its wholly owned subsidiary Takeda Pharmaceuticals North America (TPNA), have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their abbreviated new drug applications (ANDAs) for generic Actos (pioglitazone HCl) and Actoplus met (pioglitazone HCl and metformin HCl).
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Takeda has executed agreements with Mylan Pharmaceuticals (Mylan), Watson Pharmaceuticals (Watson), Ranbaxy Pharmaceuticals (Ranbaxy), Alphapharm (Alphapharm), Torrent Pharmaceuticals (Torrent) and Sandoz and their respective affiliates, to settle patent infringement litigation brought against them relating to their ANDAs for generic Actos.
Takeda Pharmaceutical has pending patent infringement lawsuits against two companies Teva Pharmaceutical (Teva) and Aurobindo Pharma (Aurobindo). The companies seek to market generic versions of Actos and Actoplus met before the expiration of several Takeda patents in mid-2016.
The patents at issue claim the combinations of pioglitazone with metformin, insulin secretion enhancers, or insulin. Until these lawsuits are resolved or concluded, the dates of entry of generic Actos and Actoplus met are uncertain. Additional companies may also file ANDAs for generic Actos products, and Takeda is aware of two other companies that have already done so.
Takeda has granted Mylan, Watson and Ranbaxy licenses to enter the US market with generic pioglitazone on August 17, 2012. Takeda has also granted Alphapharm, Sandoz and Torrent licenses to enter the US market with generic Actos 180 days after Mylan, Watson and Ranbaxy.
Additionally, Takeda has granted Mylan a license to enter the US market with generic Actoplus met on December 14, 2012.