New Delhi: Ranbaxy Laboratories Ltd on Monday said that it has entered into an agreement with the Japanese drug maker Takeda Pharmaceuticals for ending the patent litigation regarding diabetic drug Actos.
Under the terms of the agreement, Takeda has granted a non-exclusive royalty free license to its patent covering Actos, Ranbaxy said in a statement.
As per the terms of the agreement Ranbaxy would be able to launch the generic version of the drug Actos in the US market on 17 August, 2012. However, the drug could be launched earlier also depending upon the circumstances.
“This agreement will allow Ranbaxy Pharmaceuticals Inc (RPI) to bring to patients with diabetes a generic alternative in this important therapeutic area,” RPI vice president of sales and distribution Jim Meehan said.
Ranbaxy entered into the agreement along with its US-based wholly-owned subsidiary Ranbaxy Pharmaceuticals Inc, while Takeda also signed the pact with its fully-owned subsidiary Takeda Pharmaceuticals North America.
Takeda has simultaneously signed agreements with other players to end the patent infringement litigations pending in US courts regarding Actos which is also known by its chemical name Pioglitazone Hydrochloride and is available in 15 mg, 30 mg and 45 mg strengths.
According to market research firm IMS, Actos had reported a sale of approximately $3.4 billion in US for the twelve months ending 31 December, 2009.
As per the information available, Takeda has filed patent infringement litigations against Mylan Pharmaceuticals, Ranbaxy Laboratories and Watson in 2003 in a US court.
This was filed on the basis of response to the filing of Abbreviated New Drug Applications (ANDA) with the Food and Drug Administration under provisions of the Hatch-Waxman Act challenging certain of Takeda’s patent.
According to Hatch-Waxman Act any generic firm which successfully challenges the patented drugs would get an exclusive marketing rights for 180 days before the expiry of patents.