Ranbaxy Laboratories today said it plans to launch more generic products in the US market with possible marketing exclusivity,while keeping options open for overseas acquisitions to grow its business in various global markets.
We continue to make regular submissions in the US … and will continue to make first-to-file (FTF) filings there. Our target is to do somewhere between three to four FTFs every year, Ranbaxy CEO and Managing Director Arun Sawhney told PTI in an interview.
The USFDA grants FTF status to a company for a product if it is the first to successfully apply and get approval to launch a generic copy of a patented drug,and it gets 180-day marketing exclusivity.
Looking to move on after the issues in the US,where it has pleaded guilty to felony charges for manufacturing norms violation and is to pay $500 million to the authorities,
Sawhney said Ranbaxy would also be focusing on its branded business there.
We have a very strong pipeline of products for the US … Absorica (acne medicine) is doing very well for us and this will continue. The differentiated product strategy will continue in the US, he said.
Ranbaxy was the first firm to launch generic Lipitor in the US market after Pfizers patent expired in 2011 and enjoyed marketing exclusivity for the first six months. It is estimated to have generated sales of $600 million during its exclusive marketing period.