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Takeda Completes Settlements With All Defendants in U.S. Patent Litigation Involving ACTOS® (pioglitazone HCI), ACTOplus met® (pioglitazone HCl and metformin HCl) and duetact® (pioglitazone HCl and glimepiride)
Date:12/21/2010

million patients to date.

Summary of Settlements

Takeda has granted Mylan, Watson, and Ranbaxy licenses to enter the U.S. market with generic ACTOS on August 17, 2012, subject to regulatory approval, or earlier under certain circumstances.

Mylan, Watson, and Ranbaxy are first-filers of ANDAs with paragraph IV certifications for ACTOS, and it is anticipated that the U.S. Food and Drug Administration will grant these companies 180-day marketing exclusivity. Takeda has granted Alphapharm, Sandoz, Aurobindo, Dr. Reddy, Wockhardt, the Synthon defendants, Teva, and Torrent licenses to enter the U.S. market with generic ACTOS beginning 180 days after the first-filers, subject to regulatory approval. Takeda has granted Teva a license to market an authorized generic version of ACTOS in the U.S. beginning on August 17, 2012, or earlier under certain circumstances.

Takeda also has granted Mylan a license to market generic ACTOplus met in the U.S. on December 14, 2012, or earlier under certain circumstances, subject to regulatory approval. As a first-filer of a patent certification for this product, it is anticipated that Mylan will receive 180 days of marketing exclusivity. Sandoz, Ranbaxy, Torrent, Watson, Aurobindo, Wockhardt, and Teva have been granted licenses to enter the U.S. market with generic ACTOplus met beginning 180 days after the first-filer, or earlier under certain circumstances, subject to regulatory approval. Takeda has granted Teva a license to market an authorized generic version of ACTOplus met in the U.S. beginning on December 14, 2012, or earlier under certain circumstances.

Lastly, Takeda has granted Sandoz a license to enter the U.S. market with generic duetact on December 14, 2012, or earlier under certain circumstances.

About ACTOS® (pioglitazone HCl) Family of Products Indications and Usage

ACTOS® (pioglitazone HCl), ACTOplus met® (p
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SOURCE Takeda Pharmaceuticals North America, Inc.
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