"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 USD 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 Pfizer's 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.
Commenting on the overall growth strategy, he said: "We have identified key areas and key therapeutic segments in which we will grow our business both organically and or inorganically."
When asked which are the markets where it would look for acquisitions, Sawhney said: "US, India, Eastern Europe, Africa, Malaysia, these are the areas in the world where we would be willing to make investments for our future growth."
On the funds that the company has earmarked for possible acquisitions, he said: "If we have good opportunity money would not be a constraining factor. We would be more keen to look at opportunity rather than earmark some money to be spent."
The Gurgaon-based firm's last major overseas acquisition was that of Romanian firm Terapia in 2006 for $324 million. Commenting on the Indian business, Sawhney said the company would continue to focus on both the prescription as well as the OTC market.
"Like elsewhere in the world, we have ambitious growth plans in India as well. We will be putting a lot of resources behind strengthening our existing strong brands," Sawhney said. Ranbaxy will continue its efforts to remain dominant in segments like antibiotics and acute therapy, he added.
"At the same time, we would like to grow on the chronic side also, so there could be concerted effort to grow the business in the chronic sector even in India," he said.
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