Takeda has executed agreements with Mylan Pharmaceuticals, Inc. ("Mylan"), Watson Pharmaceuticals, Inc. ("Watson"), Ranbaxy Pharmaceuticals, Inc. ("Ranbaxy"), Alphapharm Pty. Ltd. ("Alphapharm"), Torrent Pharmaceuticals Limited ("Torrent"), and Sandoz, Inc. ("Sandoz") and their respective affiliates, to settle patent infringement litigation brought against them relating to their ANDAs for generic ACTOS. Takeda has granted Mylan, Watson and Ranbaxy licenses to enter the United States (U.S.) market with generic pioglitazone on August 17, 2012. The license date could be earlier than August 17, 2012 under certain circumstances. Mylan, Watson and Ranbaxy are first-filers of ANDAs with paragraph IV certifications for generic ACTOS, and it is anticipated that the U.S. Food and Drug Administration (FDA) will grant them 180-day marketing exclusivity. Takeda has granted Alphapharm, Sandoz and Torrent licenses to enter the U.S. market with generic ACTOS 180 days after Mylan, Watson and Ranbaxy.

In addition, Takeda has granted Mylan a license to enter the U.S. market with generic ACTOplus met on December 14, 2012. The license date could be earlier than December 14, 2012 under certain circumstances. Mylan is the first-filer of an ANDA with a paragraph IV certification for generic ACTOplus met, and it is anticipated that the FDA will grant it 180-day marketing exclusivity for this product. Takeda has granted Ranbaxy, Sandoz, Watson and Torrent licenses to enter the U.S. market with generic ACTOplus met beginning 180 days after Mylan.

The litigation mentioned above for ACTOS and ACTOplus met is pending in the U.S. District Court for the Southern District of New York.

SOURCE Takeda Pharmaceutical Company Limited