Lupin gets USFDA nod to market HIV drug in US market

Lupin shares gains more than 1% on US health regulator’s nod for generic Trizivir tablets

New Delhi December 11, 2013:  

Drug major Lupin Ltd on Tuesday said it has received US health regulator’s approval to market generic version of ViiV Healthcare Ltd’s Trizivir tablets, used in the treatment of HIV-1 infection, in the American market.

The company has received final approval from the US Food and Drug Administration (USFDA) for its Abacavir Sulfate Lamivudine, and Zidovudine tablets, Lupin said in a statement.

The company’s product is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection, it added.

“Lupin was the first applicant to file an abbreviated new drug application (ANDA) for Trizivir tablets and as such will be entitled to 180 days of marketing exclusivity,” the company said.

According to IMS MAT September 2013 sales data, Trizivir tablets has US sales of around $111.6 million.

Lupin’s cumulative ANDA filings with the USFDA as of 30 October stands at 183 and the Mumbai-headquartered firm has received 93 approvals to date.

During the current year, the company has so far received 17 approvals from USFDA. It has also launched 13 products in the US market in the current year so far.

“Lupin is the market leader in 26 products in the US generic market and is amongst the top three by market share in 40 products out of the overall 57 products in the market,” it the company said.

Shares of Lupin were trading at Rs.863.70 a piece on the BSE in afternoon trade, up 1.28% from its previous close.