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
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