Indian pharma major Ranbaxy Laboratories Ltd, which has sole marketing rights of acne treatment drug Absorica in US, has received a notice from Watson Laboratories Inc challenging the drug’s patent.
Ranbaxy Laboratories Inc (RLI), which has licensed marketing of the drug from Cipher Pharmaceuticals Inc based out of Mississauga, Ontario, has announced that it plans to defend its intellectual rights through all available legal and regulatory ways.
The company claims that Absorica drug was approved by US FDA in May 2012 and has been granted a three-year market exclusivity period which will expire in May 2015.
The drug itself is protected by two issued patents listed in FDA’s Approved Drug Products List which will expire in September 2021.
According to regulatory norms in US, a generic firm can file an abbreviated new drug application (ANDA) challenging patent of drug under Paragraph IV certification. If successful, the application can give the challenger 180 days of marketing exclusivity to market the generic drug. After Para IV notice, the branded company has 45 days to file a patent infringement action against the generic company.
Once the suit has been filed, the FDA cannot approve the application until the generic company successfully defends the suit or until 30 months, whichever comes first.
Ranbaxy Laboratories Ltd, promoted by Japanese pharma major Daiichi Sankyo, has been facing quite a few challenges since the company pleaded guilty of making fraudulent statements to the US FDA for gaining approvals for its products. For this the company agreed to pay a penalty of $500 million to US Department of Justice (DoJ).
Recently, Ranbaxy got an import alert for its facility in Mohali. This bans any products manufactured at the facility to be exported in the US. This is third facility of the company which has been banned by the drug regulator after those in Dewas, Madhya Pradesh and Paonta Sahib, Himachal Pradesh.
(Edited by Joby Puthuparampil Johnson)