Drug-maker Lupin is set to enter the US oral contraceptive market. The company has received final approval from the US Food and Drug Administration to market a generically similar version of Watson's oral contraceptive NOR-QD tablets.
Lupin will shortly commence the shipping of its version of norethindrone tablets, a progestin-only oral contraceptive indicated for the prevention of pregnancy.
Strong pipeline
Though the first of the OC products off the block is a small one, with an estimated sales of $52 million for the year ended June 2011, Lupin has a 26-product strong OC pipeline, said Mr Nilesh Gupta, Lupin's Group President and Executive Director.
“We are putting a big basket together,” he told Business Line, adding that another five more abbreviated new drug applications (ANDA) would be filed in the US. A couple of the OC filings would be patent challenges, he said.
Global portfolio
The opportunity of the OC segment is pegged at $5 billion, he added. Looking to create a global OC portfolio, product filings are also being made in Europe, Canada, and Latin America, he said.
The other large generic players in this therapeutic segment include Watson and Teva. But Lupin is the only one that is vertically integrated, he said.
Companies in the segment including Glenmark, Sandoz and Mylan, besides Teva and Watson, source the bulk ingredient or finished drug form from other companies, he clarified. Lupin's products will be made at its Indore facility, he added.
While the launch is according to schedule, he said, it is unlikely to make a “reasonable dent” in the first year. Lupin's US sales are at $500 million. Next on the agenda is the ophthalmic segment, with about eight product filings by the end of the next fiscal. Other therapeutic segments that Lupin would subsequently roll out products in include dermatology and asthma.
Lupin shares closed up over 2 per cent on the BSE at Rs 482 on Tuesday.