Lupin launches HIV drug in the US with marketing exclusivity

Company is the first applicant to file an ANDA for Trizivir tablets and as such is entitled to 180 days of marketing exclusivity

Drug major Lupin today said it has launched the generic version of ViiV Healthcare's (ViiV) Trizivir tablets in the US market with 180-days of marketing exclusivity.

The company said its US subsidiary Lupin Pharmaceuticals Inc has launched Abacavir Sulfate, Lamivudine, and Zidovudine tablets in the US market after the US District Court for the District of Delaware ruled that Lupin's generic version of Trizivir did not infringe on patents, Lupin said in a statement.

The Mumbai-headquartered firm had earlier received approval from the US Food and Drug Administration (USFDA) for the same.

"Lupin is the first applicant to file an abbreviated new drug application (ANDA) for Trizivir tablets and as such is entitled to 180 days of marketing exclusivity," it added.

The company's product is the generic equivalent of ViiV Healthcare's Trizivir tablets and is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.

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

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

During the current year, the company has so far received 18 approvals from USFDA. It has also launched 14 products in the US market in the current year so far.

Shares of Lupin were trading at Rs 895.25 a piece on the BSE in late afternoon trade, up 1.63% from its previous close.