The largest drug firm of Japan, Takeda Pharmaceuticals has filed a suit against Ahmedabad headquartered Cadila Healthcare at a US district court alleging that the latter would be infringing the former?s patent coverage by attempting to manufacture and market diabetes drug Actos (pioglitazone hydrochloride) in the US market.
Actos, which is used to improve glycemic control in type-II diabetes patients, is a blockbuster drug that clocked revenues worth $3.4 billion only in the US market for the year ending December 31, 2009, according to data of market research firm IMS. The product is among the largest selling diabetic drugs globally and the eighth largest selling prescription drug in any therapeutic segment in the US market.
Takeda has already resolved patent litigation with eleven generic companies chasing the diabetes drug opportunity in the US market early this year. These included settlements with at least five Indian players such as Gurgaon-based Ranbaxy Labs which is owned by Takeda?s rival at home Daiichi Sankyo, Torrent Pharmaceuticals, Dr Reddy’s Lab, Wockhardt and Aurobindo Pharma.
The other companies which entered into the agreement with Takeda to resolve the patent litigation over Actos, Actoplus met (pioglitazone HCl and metformin HCl), and duetact (pioglitazone HCl and glimepiride) are Mylan Pharmaceuticals, Watson Pharmaceuticals, Alphapharm, Sandoz, Teva Pharma among others.
According to the terms of agreement, Takeda has allowed Ranbaxy along with generic firms Mylan and Watson to market a low-cost generic version of Actos in the US starting August 17, 2012 ? almost 19 months after the basic patent over Actos expires in the US on January 17, 2011. Ranbaxy, Mylan and Watson were the first-filers of Abbreviated New Drug Applications at the US Food and Drug Administration. In its out of court settlement with other generic firms, the Japanese firm has consented to allow marketing of the generic version 180 days after August 17, 2012. The global anti-diabetic market has crossed $25 billion.