Lupin gets preliminary nod for generic HIV drug Lexiva in US
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Hyderabad: m Lupin Ltd, India’s third largest drug maker on Wednesday said its US unit Lupin Pharmaceuticals Inc. has received preliminary approval from the US drug regulator to market a generic equivalent of GlaxoSmithKline Plc’s ViiV Healthcare’s (ViiV) antiretroviral (ARV) Lexiva tablets in 700 milligram dosage form.
Lexiva generically called fosamprenavir calcium tablets is used with other antiretroviral agents for the treatment of HIV-1 infection.
Lupin said Lexiva had US sales of $71.6 million in the year ended March, citing US-based healthcare information provider IMS Health.
Lupin is locked in a patent litigation with ViiV Healthcare, the main patent Lexiva will expire in December, 2017 with a paediatric exclusivity that runs until June 2018.
“This product was filed from Lupin’s Goa formulations manufacturing facility,” Lupin said.
Shares of Lupin rose 1.12% to close at Rs.1718.90 on BSE, the benchmark Sensex gained 0.17% to 28,024.33 points.