Takeda Completes Settlements With All Defendants in U.S. Patent Litigation Involving ACTOS® (pioglitazone HCI), ACTOplus met® (pioglitazone HCl and metformin HCl) and duetac...

Tue, 12/21/2010 - 5:35pm

DEERFIELD, Ill. and OSAKA, Japan, Dec. 21, 2010 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), 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). Takeda filed the lawsuits to enforce several patents that expire in 2016 relating to ACTOS, ACTOplus met, and duetact.

Agreements have been reached with the following generic companies and their respective affiliates: Mylan, Inc. ("Mylan"), Alphapharm Pty. Ltd. ("Alphapharm"), Watson Pharmaceuticals, Inc. ("Watson"), Ranbaxy Laboratories Limited ("Ranbaxy"), Sandoz, Inc. ("Sandoz"), Teva Pharmaceutical Industries, Ltd. ("Teva"), Torrent Pharmaceuticals Limited ("Torrent"), Dr. Reddy's Laboratories, Limited ("Dr. Reddy"), Wockhardt Limited ("Wockhardt"), Synthon Pharmaceuticals, Inc. ("Synthon") and Breckenridge Pharmaceutical, Inc. ("Breckenridge") (collectively, "the Synthon defendants"), and Aurobindo Pharma Limited ("Aurobindo").

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 August 17, 2012, and that market entry of generic ACTOplus met and generic duetact will occur on December 14, 2012. With these settlements, the forecasts of Takeda's consolidated results for the full year of fiscal 2010 announced on October 29, 2010 will not be changed.

Takeda is the inventor and developer of ACTOS, which was launched commercially in the United States (U.S.) in 1999 for the treatment of type 2 diabetes and has been prescribed for more than 10





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