Drug maker Lupin Ltd is expected to soon launch its generic version of the anti-HIV drug, Combivir, in the United States. The move was likely to lend a significant upside to the Mumbai-based company’s bottom line in the forthcoming quarters, a source said.
Lupin’s drug, a combination of lamividine and zidovudine tablets, is a generic version of Viiv Healthcare’s Combivir that is prescribed in combination with other antiretroviral agents for the treatment of HIV-1 infection. “Lupin is likely to launch generic Combivir in the US as early as this month,” the source said. The 1968-founded company is waiting for the final approval from the US Food and Drug Administration (FDA).
The drug maker received a tentative approval last year from the US FDA for the generic drug in two strengths — of 150 mg and 300 mg. Now, it will have to wait for the final approval from the drug regulator before it launches the medicine in the world’s largest drug market. Another pharmaceutical company, Israel’s Teva, had also received approval last year to exclusively sell the generic drug in the US for 180 days. “Teva’s 180-day exclusivity on the generic product is now over,” the source said. “Lupin has a cut-off date in May to launch the product.”
When contacted, Lupin refused to divulge details. “As a policy, we don’t give future guidance and comment on product approval or launches,” a spokesperson of the company said in an e-mail response.
Analysts see the proposed launch as a major positive for a company, given the significant size of the market coupled with limited competition in the segment. Shares of Lupin Ltd closed session at Rs 515 on Friday — down 1.4 per cent on the National Stock Exchange.
According to analysts, the Combivir in the US has a total market size of around $315 million annually. Initially, Lupin may aim at capturing around 15-17 per cent of the drug market and may expand further with scope, the source said.
“Other than the innovator and Teva, there are no other companies with approval for the drug,” according to an analyst from a Mumbai based brokerage. “So, if Lupin launches the drug in the US now, it may make major contributions to its revenues as the company can grab a remarkable size of the total market. It will be the only second company to launch the generic.”