Lupin receives US FDA approval for generic Trizivir

Lupin Limited has received final approval for its abacavir sulfate, lamivudine, and zidovudine tablets, 300 mg (base) / 150 mg / 300 mg from the US Food and Drugs Administration (FDA) to market a generic version of ViiV Healthcare’s Trizivir tablets, 300 mg (base) / 150 mg / 300mg. 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.

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