FDA tentatively approves Dr. Reddy's generic lenacapavir, a $40-a-year HIV prevention shot for poorer countries
- The FDA gave tentative approval to Dr. Reddy's Laboratories to make a generic version of lenacapavir, an injectable for HIV prevention.
- The company plans to begin shipping next month, with global health organizations helping speed delivery to lower-income countries.
- The annual cost is put at $40 per person.
- One dose every six months gives near-complete protection; Gilead's branded version won FDA approval in June 2025, so the generic's tentative approval came about 16 months later, unusually fast.
💡 Points Based on public reports
About $40 a year against a branded US price in the tens of thousands is the point. But this is tentative approval, not full, so supply depends on Gilead's voluntary-license territories. Watch real procurement volumes and whether twice-yearly dosing reaches clinics, since delivery, not price, may become the bottleneck.
FDA OKs generic HIV prevention shot, widening access for lower-income countries ↗