Lupin Secures USFDA Approval for Raltegravir Tablets, Gains 180-Day Generic Exclusivity

Lupin Ltd. has received approval from the United States Food and Drug Administration for its Raltegravir Tablets USP, 600 mg, marking a significant milestone in its pharmaceutical portfolio. The approval allows Lupin to market a generic equivalent of Isentress HD, a widely used antiretroviral medication for the treatment of HIV-1 infection.

 

Raltegravir is an integrase inhibitor that prevents the virus from replicating by blocking its ability to integrate into human DNA. The drug is prescribed in combination with other antiretroviral agents for adult and pediatric patients weighing at least 40 kg. Lupin’s approval strengthens its presence in the HIV treatment segment, offering a cost-effective alternative to the branded version.

 

As the first-to-file applicant for this generic drug, Lupin is eligible for 180 days of market exclusivity in the United States. This exclusivity period provides the company with a competitive advantage, limiting the number of generic competitors during the initial phase of commercialization.

 

The approval comes at a time when Lupin is expanding its footprint in the US pharmaceutical market, focusing on complex generics and specialty drugs. The company’s Nagpur facility will manufacture the Raltegravir tablets, ensuring quality and compliance with regulatory standards.

 

Pharmaceutical Approval Highlights:

Sources: Lupin Ltd., Economic Times, Business Standard, Moneycontrol, Pharma Economic Times.