Lupin Limited has informed the Exchange regarding a press release dated May 08, 2025, titled "Lupin Receives Approval from U.S. FDA for Raltegravir Tablets USP, 600 mg".
LUPIN · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Lupin has received US FDA approval for its generic version of Raltegravir Tablets 600 mg, used in combination with other drugs to treat HIV-1 infection in adults and children weighing at least 40 kg. The product is bioequivalent to Merck Sharp & Dohme's branded Isentress HD. Lupin is the exclusive first-to-file applicant, making it eligible for 180 days of generic drug exclusivity in the US market. The tablet will be manufactured at Lupin's Nagpur facility in India. The reference brand had estimated annual US sales of about USD 34 million (IQVIA MAT March 2025).
Positive for shareholders — the first-to-file status with 180-day exclusivity means Lupin will likely capture a dominant share of the USD 34 million US market for this product, adding a new revenue stream to its US generics portfolio.