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US court ends early generic Actos hope for Alphapharm
  07 April 2008
A US Court has put a lid on Australian firm Alphapharm's hopes of getting a generic form of the multibillion-dollar diabetes drug Actos (pioglitazone) onto the world's largest pharmaceutical market, after ruling in favour of the medicine's manufacturer Takeda.
The decision supports an earlier appeals court decision and means that Alphapharm - which last year became part of US company Mylan - will now be unable to launch its copycat offering until the patent officially runs out in 2011, giving Japan's Takeda four more years of lucrative business.
Actos could prove to be an even greater revenue earner for Takeda after data from the PERISCOPE study - presented at the American College of Cardiology meeting in Chicago last month - showed its potential in preventing plaque from being laid down in the arteries of patients with diabetes. This is the first study to demonstrate that a diabetes treatment is capable of preventing the progression of atherosclerosis.
The drug, despite receiving stronger label warnings recently, brought in around $2.86 billion in the last fiscal year, more than 25% of the firm's total revenues. In January it submitted its Actos follow up - alogliptin - to the US Food and Drug Administration in a bid to get it established on the market ahead of Actos' 2011 patent expiry.
Takeda Wins Definitive Decision in Patent Infringement Litigation on Appeal against an ANDA Filer for Generic ACTOS
Osaka, Japan and Deerfield , Ill. (April 4, 2008) - Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA") announced today that, on March 31, 2008, the U.S. Supreme Court denied the Petition for a Writ of Certiorari by Alphapharm Pty Ltd[ * ].
The Supreme Court decision finally affirms the Appeals Court decision upholding the validity of Takeda's U.S. Patent No. 4,687,777 ("777") covering pioglitazone hydrochloride, the active ingredient in ACTOS. The decision arises from a lawsuit brought by Takeda and TPNA in March 2004 in order to oppose an Abbreviated New Drug Application (ANDA) filed by Alphapharm Pty Ltd.
Based on this final decision, the FDA will not approve and Alpharpharm Pty Ltd. may not launch a generic version of pioglitazone until the "777" patent expires in 2011.
Takeda owns other U.S. patents covering certain methods of treatment using pioglitazone hydrochloride and certain compositions that include pioglitazone hydrochloride.
"We are very pleased that the fair and appropriate ruling regarding this litigation was confirmed by the Supreme Court," said Mr. Yoichi Okumura, General Manager of Intellectual Property Dept. of Takeda. "We have profound respect for the protection of intellectual property rights because innovation is critical to us as an R&D-oriented pharmaceutical company."
[ * ] Alphapharm Pty. Ltd., and Genpharm, Inc.
About Takeda
Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan, and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, About Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, lll., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets diabetes, insomnia, wakefulness and gastroenterology, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. To learn more about the company and its products, visit
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