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DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.
Takeda and Takeda Pharmaceuticals North America granted Mylan, Watson and Ranbaxy licenses to enter the U.S. market with generic Actos on Aug. 17, 2012, subject to regulatory approval, or earlier under certain circumstances. Mylan, Watson and Ranbaxy are first-filers of abbreviated new drug applications with paragraph IV certifications for Actos, and it is anticipated that the Food and Drug Administration will grant these companies 180-day marketing exclusivity, Takeda said.
Takeda also granted Alphapharm, Sandoz, Aurobindo, Dr. Reddy, Wockhardt, the Synthon defendants, Teva and Torrent licenses to enter the U.S. market with generic Actos beginning 180 days after the first-filers, subject to regulatory approval. Takeda has granted Teva a license to market an authorized generic version of Actos in the United States beginning on Aug. 17, 2012, or earlier under certain circumstances.
Takeda is the inventor and developer of Actos, which was commercially launched in the United States in 1999 for the treatment of Type 2 diabetes and has been prescribed for more than 10 million patients to date.