Japan’s Takeda Pharmaceutical Company has settled patent infringement suits out of court with 11 generic drug companies, including Ranbaxy Laboratories, Torrent Pharmaceuticals, Dr Reddy’s Laboratories, Wockhardt and Aurobindo Pharma, over its flagship diabetes drug Actos and its variants.
The settlement will help Ranbaxy, along with Mylan and Watson, launch generic versions of the drug on August 17, 2012 or earlier under certain circumstances. These three companies are the first to challenge the patent of this drug with paragraph IV marketing applications in the US, which will help to gain 180-day marketing exclusivity during the launch.
Takeda has also granted Israeli drug company Teva a licence to market an authorised generic version of the drug in the US during the same period. Rest of the generic companies, including Dr Reddy’s, Torrent, Wockhardt and Aurobindo Pharma, can launch their versions after the 180-day exclusive period.
According to data of drug sales tracking agency IMS, Actos and its variants had sales of $4 billion last year. Takeda is the inventor and developer of Actos, which was launched commercially in the US in 1999 for the treatment of type 2 diabetes and has been prescribed for more than 10 million patients to date.
Takeda had filed the lawsuits against these companies to enforce several patents that expire in 2016 relating to Actos, Actoplus met, and Duetact. Actos (pioglitazone HCl), Actoplus met (pioglitazone HCl and metformin HCl), Actoplus met XR (pioglitazone HCl and extended-release metformin HCl), and Duetact (pioglitazone HCl and glimepiride) are prescription medications to improve blood sugar (glucose) control in adults with type 2 diabetes.