Takeda Pharmaceutical Company Limited announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("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). Takeda recently concluded litigation with the sixth settling defendant.
While preparing the fiscal 2010 financial outlook and Mid-Range Plan, Takeda is operating on the assumption that the entry of generic versions of ACTOS and ACTOplus met will be August 17, 2012 and December 14, 2012, respectively. FY 2010 financial outlook, as a part of FY 2009 Earnings Release, and the Mid-Range Plan will be announced on May 12, 2010 at 3 p.m., Japan Time.
Takeda has pending patent infringement lawsuits against two companies - Teva Pharmaceutical Industries, Ltd. ("Teva") and Aurobindo Pharma Limited ("Aurobindo"). These 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 is confident in and intends to continue to enforce its patents.
Summary of Settlements To Date
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.