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Takeda Provides Update on Patent Litigation for ACTOS(R) (pioglitazone HCl) and ACTOplus met(R) (pioglitazone HCl and metformin HCl) in the U.S.
Date:4/28/2010

OSAKA, Japan and DEERFIELD, Ill., April 28 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") 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
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SOURCE Takeda Pharmaceutical Company Limited
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