India Exchange Filings

Lupin Raltegravir U.S. Launch

Lupin Ltd launches U.S. generic raltegravir 600 mg tablets after FDA approval; it is the exclusive first-to-file applicant

  • Bioequivalent to Isentress HD; indicated for certain adult and pediatric patients with HIV-1, in combination with other antiretroviral agents.
  • Eligible for 180-day generic drug exclusivity.
  • U.S. annual sales were estimated at US$26 million for the 12 months ended September 2026, per IQVIA.

Original Filing

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