RANBAXYLaboratories has reached an out-ofcourt settlement with Japanese company Astellas and Boehringer Ingelheim to sell Flomax, a drug used in the treatment of benign enlargement of prostate, in the US.
Boehringer Ingelheim has the exclusive marketing rights for the drug in the US. The settlement allows Ranbaxy Laboratories to launch the drug in the US market on March, 2010 - eight weeks prior to the expiry of the six-month additional exclusivity which the patent holder hopes to get.
During the two month period, Ranbaxy Laboratories will be the only generic manufacturer to sell the product in the US.
The company is expected to get an upside of around $250 million during two-month exclusivity.
“We are delighted on the settlement which brings certainty for the launch of the product on an exclusive period before the patent expires,” Ranbaxy Laboratories CEO and MD Malvinder Singh said. The annual sales of Flomax is estimated to be $1.2 billion as per IMS and growing at 15%. Ranbaxy Laboratories received tentative approval from the US Foods and Drugs Administration for Tamsulosin in June. “Ranbaxy Laboratories has reached an agreement with Astellas and Boehringer Ingelheim to stipulate a remand of the pending Federal Circuit appeal and subsequent vacatur of the District Court decision in regards to Flomax. The case between Ranbaxy and Astellas has been dismissed without prejudice,” a Ranbaxy Laboratories release said.
The lawsuit in the US was related to Astellas’ US Patent No. 4,703,063 (‘063 patent), covering Tamsulosin and its use in the treatment for functional symptoms of benign prostatic hyperplasia, it added.
Ranbaxy has resolved a US patent dispute over tamsulosin capsules
Tamsulosin is used to treat benign prostatic hyperplasia
Total annual sales of Flomax is over $1.2 b
During exclusivity period, Ranbaxy will be the only generic co to commercialise the product in US market