The largest Japanese drug firm, Takeda Pharma, has sued Hyderabad-based Dr Reddy?s Labs for allegedly infringing the former?s patent coverage on anti-diabetic drug Actos (pioglitazone hydrochloride) by trying to manufacture and market the same in the US. 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.
The drug clocked revenues worth $3.4 billion in 2009 in the US alone, according to the National Prescription Audit conducted by the IMS. The case has been filed by Takeda in the US District Court, Southern District of New York.
Takeda has already arrived at a settlement with atleast six generic drug firms on the same product. Those firms sought to launch the drug earlier than the expiry date of the patent .
Apart from two Indian players ?? the US subsidiary of Ranbaxy Labs Ltd and Torrent Pharmaceuticals, the other drugmakers with whom Takeda has executed the patent litigation agreement out of court include Mylan Pharma, Watson Pharma, Alphapharm Pty and Sandoz. The other players in the race to cash in on the blockbuster generic opportunity include Indian drugmaker Aurobindo Pharma and Israeli player Teva Pharma.
Takeda has granted Mylan, Watson and Ranbaxy licenses to enter the US market with generic pioglitazone on August 17, 2012, which is almost 19 months after the basic patent over Actos expires in the US on January 17, 2011.
Most other patents related to the drug are scheduled to expire in 2016. The licence date in the agreement between Takeda and the three generic players could be earlier than August 17, 2012 under certain special circumstances–which were not disclosed.
Pioglitazone Hydrochroride is a prescription medication used to control type 2 diabetes in adults.