Tuesday 10 December 2013

Lupin receives FDA approval for Generic Trizivir Tablets

Pharma Major Lupin (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 U.S sales of approximately $ 111.6 million (IMS MAT Sep, 2013).

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