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.
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).
EP News Bureau – Mumbai