Mumbai, India, 3 November 2026: Lupin Limited, a prominent player in the global pharmaceutical industry, has announced the launch of its Raltegravir Tablets USP, 600 mg in the United States. This development follows the approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration (FDA). The tablets are bioequivalent to Merck Sharp & Dohme’s Isentress® HD Tablets and are intended for use in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
As the first company to file for this generic version, Lupin is entitled to a 180-day exclusivity period in the U.S. market. This exclusivity is a significant advantage, allowing Lupin to be the sole generic provider for this duration. The Raltegravir Tablets USP, 600 mg, have an estimated annual sale of USD 26 million in the United States, according to IQVIA data as of September 2026. This launch is expected to strengthen Lupin’s presence in the U.S. market, particularly in the antiretroviral segment.
Lupin Limited, headquartered in Mumbai, India, has a robust global footprint, with products distributed in over 100 markets. The company is known for its diversified portfolio, which includes generics, complex generics, specialty medicines, and biosimilars. It holds a strong market position in key therapeutic areas such as cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. Lupin’s operations are supported by 15 manufacturing facilities and six research centres, with a workforce exceeding 26,000 professionals.
The launch of Raltegravir Tablets in the U.S. aligns with Lupin’s strategy to expand its healthcare offerings and maintain its leadership in the pharmaceutical industry. Analysts view this development as a positive step for Lupin, potentially boosting its revenues and market share in the competitive U.S. pharmaceutical market. The company’s focus on sustainability and innovation continues to drive its growth and strengthen its position as a global healthcare leader.
