News ArticleLupin launches Raltegravir 600 mg tablets in the US as first-to-file generic with 180-day exclusivity
Raltegravir Tablets USP 600 mg approved by US FDA and bioequivalent to Merck’s Isentress HD with estimated USD 26 million annual sales
Lupin Limited announced the launch of Raltegravir Tablets USP 600 mg in the United States following FDA approval. As the first-to-file, Lupin gains 180-day generic drug exclusivity for this HIV-1 treatment option, with the reference drug's U.S. annual sales at USD 26 million.
Lupin Limited
New Ventures
Lupin Limited announced the launch of Raltegravir Tablets USP 600 mg in the United States after receiving US FDA approval, qualifying for a 180-day generic exclusivity as the first-to-file for this HIV-1 treatment.
The approved Raltegravir Tablets are bioequivalent to Merck Sharp & Dohme LLC’s Isentress HD Tablets 600 mg and indicated for combination therapy to treat HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
Lupin’s Raltegravir product is eligible for 180-day generic drug exclusivity, granting it a period of market exclusivity in the US against other generics.
The reference listed drug, Isentress HD, had estimated annual US sales of approximately USD 26 million as of September 2026, according to IQVIA MAT data.
Lupin is a global pharmaceutical company headquartered in Mumbai with a presence in over 100 markets, offering generics, specialty medicines, and biosimilars, supported by 15 manufacturing facilities and 6 research centers.
Highlights
- US FDA approval secured for Raltegravir Tablets USP 600 mg
- Lupin is the first-to-file and eligible for 180-day generic exclusivity
- Raltegravir used for HIV-1 treatment in adults and pediatric patients (≥40 kg)
- Bioequivalent to Merck’s Isentress HD with USD 26 million estimated annual US sales
- Launch expands Lupin’s footprint in US antiretroviral market
Key Data Snapshot
What happened
- Lupin Limited launched Raltegravir Tablets USP 600 mg in the US following FDA approval.
- The product is bioequivalent to Merck’s Isentress HD Tablets 600 mg.
- Lupin secured 180-day generic exclusivity as the first-to-file for this drug.
Key details
- Raltegravir is used in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
- The launch expands Lupin’s product portfolio in the competitive US pharmaceutical market.
- The reference drug Isentress HD had an estimated annual US sales value of USD 26 million as of September 2026.
Background and context
- Lupin is a global pharmaceutical company with operations in over 100 markets.
- The company has diversified offerings including generics, specialty medicines, and biosimilars, supported by 15 manufacturing facilities and 6 research centers.
Highlights
- US FDA approval secured for Raltegravir Tablets USP 600 mg
- Lupin is the first-to-file and eligible for 180-day generic exclusivity
- Raltegravir used for HIV-1 treatment in adults and pediatric patients (≥40 kg)
- Bioequivalent to Merck’s Isentress HD with USD 26 million estimated annual US sales
- Launch expands Lupin’s footprint in US antiretroviral market
Disclosures
- Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015
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