Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceuticals North America, Inc.Dec 22 2010

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 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.