Indian drugmaker Dr Reddy's Laboratories hopes to launch two-to-three generic products in the United States this year in a bid to increase its share of a lucrative market, its chief executive said.
The company filed 14 applications with the US Food and Drugs Administration to market generic drugs in the year to March, taking total applications awaiting approvals to 23, Chief executive G V Prasad told an analysts' earnings call.
"We have now one of the most exciting generic pipelines in the US industry with the potential of introducing drugs whose branded sales last year topped $19 billion," Prasad said.
Ten of the applications pending with the FDA were patent challenges and in seven cases, Dr Reddy's was possibly the first to file the application, he said.
According to US drug rules, the first applicant successfully to challenge a patent gets six months' marketing exclusivity.
"In the United States, I think we will launch two to three products (this year) based on approvals," he said.
Prasad did not specify which drugs would be launched.
"It is three years since Dr Reddy's entered the US generics market and we are already closing in on the $100 million mark," Prasad said. "We believe it is only the beginning."
The firm's North American revenues now account for one third of total revenue.
The launch of 40 mg generic form of Roche's anti-acne drug Accutane depended on FDA approvals, he said.
He added Dr. Reddy's could launch a generic form of Bayer Corp's anti-infective
Dr. Reddy's reaped big gains from being the exclusive generic seller of a 40 mg capsule dose of Eli Lilly's anti-depressant Prozac for six months in the latter half of 2001-02 (April-March). Sales dwindled when the exclusivity ended and competition set in.
Dr. Reddy's said sales of the fluoxetine capsules, the generic form of Prozac, dropped to Rs 1.9 billion ($40.33 million) in the past year to March from Rs 3.7 billion a year earlier.
It has not had any major US launches since Prozac's exclusivity ended, though sales of a generic form of Elan Corporation's Zanflex from July 2002 partly offset the decline from fluoxetine.
The firm, which announced results on Friday, said consolidated net profit fell 28 per cent to Rs 3.53 billion from a year earlier, according to US accounting standards.
Investors are eagerly awaiting the launch of Dr Reddy's next blockbuster drug, amlodipine maleate, a generic version of Pfizer's hypertension drug Norvasc.
Dr Reddy's is among a handful of Indian drug makers tapping the US and European markets with copies of medicines going off patent.
Dr. Reddy's spent Rs 1.4 billion on research and development last year -- 7.6 per cent of its revenue -- and Prasad said he expected R&D spending to rise by 50 per cent in the current year.
In early Wall Street trade Dr Reddy's ADRs were trading down 2.6 per cent at $18.79 after its domestic shares ended the day at Rs 892.80, up 0.3 per cent.