Lupin gains on USFDA nod for generic Trizivir tabs

The company has received approval from the USFDA to market generic Trizivir tablets in the US

Shares of Lupin were up nearly 2% at Rs 867 after the company announced that it has received approval from the USFDA to market generic Trizivir tablets in the US.

Lupin has received final approval for its Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base) / 150 mg / 300 mg from the United States Food and Drugs Administration (FDA) to market a generic version of ViiV Healthcare’s (ViiV)Trizivir® Tablets, 300 mg (base) / 150 mg / 300mg, the pharma major said in a release today on the Bombay Stock Exchange.

Lupin’s Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base) / 150 mg/ 300 mg is indicated in combination with other antiretrovirals or alone for the treatment of HIV?1 infection. Lupin was the first applicant to file an ANDA for Trizivir® Tablets and as such will be entitled to 180 days of marketing exclusivity, the release said.

Trizivir® Tablets, 300 mg (base) / 150 mg / 300mg had annual U.S sales of approximately US$ 111.6 million (IMS MAT Sep, 2013).