Last Updated on May 24, 2025 by The Health Master
USFDA approval
Lupin gets a coveted U.S. Food and Drug Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg.
This critical USFDA approval empowers Lupin to commercialize a lower-cost option to Isentress HD Tablets, 600 mg, by Merck Sharp & Dohme.
The exclusive first-to-file
Yet this is more than a standard generic USFDA approval.
Lupin is the exclusive first-to-file of Raltegravir Tablets with the USFDA.
This designation allows Lupin to enjoy an honorable 180-day exclusivity for the generic product.
For 180 days, Lupin will be the only company allowed to market Raltegravir of this strength in the United States.
Thus, existing a competitive edge before others can jump on board to capture market share.
This approval is another example of Lupin’s dedication to quality, ensuring affordable alternatives from its innovative endeavors and successful efforts within regulatory challenges.
Lupin Nagpur Facility
Lupin’s Raltegravir Tablets USP 600 mg are used for the treatment of Human Immunodeficiency Virus (HIV-1) infection.
Raltegravir is used in conjunction with other antiretroviral agents as part of a comprehensive treatment regimen for adult and pediatric (patients who weigh at least 40 kg) populations with HIV-1 infection.
Such USFDA approval demonstrates Lupin’s ability to meet quality standards and the therapeutic requirement in this niche area of HIV-1 treatment.
This generic formulation helps patients gain access where necessary.
Raltegravir tablets will be manufactured at Lupin’s state-of-the-art facility in Nagpur, India.
This showcases India’s growing role as a global hub for pharmaceutical manufacturing and Lupin’s emphasis on quality and regulatory compliance in the manufacturing process
Manufacturing drugs in India operates on a cheaper cost profile, meaning potential savings for the patient in drug pricing options.
Q. What is Raltegravir Tablet used for?
A. Raltegravir tablet is an antiretroviral HIV-1 integrase strand transfer inhibitor used to treat HIV-1 infection when combined with other antiretroviral therapies in adult populations and the pediatric population greater than or equal to 40 kg
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