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News|Articles|November 3, 2026

FDA Tentatively Approves First Generic Lenacapavir PrEP for 120 LMICs

Dr. Reddy’s generic twice-yearly lenacapavir received FDA tentative approval for HIV PrEP. It is expected to cost $40 a year in 120 llow- and middle-income countries (LMICs), with first supplies due by the end of 2026.

The FDA has granted tentative approval to the first generic version of twice-yearly injectable lenacapavir for HIV preexposure prophylaxis (PrEP), according to a new announcement from Unitaid.1 The generic is made by Dr. Reddy’s Laboratories. It is intended for the 120 low- and middle-income countries (LMICs) covered by Gilead Sciences’ voluntary licensing program, at an expected cost of $40 per person per year.1,2

Tentative approval is the FDA’s standard designation for a generic while the originator product remains under patent. It does not permit US sales, but it makes the product eligible for purchase by the US government.2 The originator, lenacapavir (Yeztugo; Gilead Sciences), carries a US list price of $28,218 per year.2

The tentative approval arrives 16 months after the FDA approved Gilead’s originator product for HIV prevention in June 2025.² Dr. Reddy’s combined the prevention and treatment indications in one application under the FDA 505(b)(2) pathway, which allowed a priority review.²

The path began in October 2024, when Gilead granted royalty-free voluntary licenses to six generic manufacturers: Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero, and Mylan.2 In September 2025, Dr. Reddy’s reached a $40 pricing agreement with three partners: Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI, a research institute of the University of the Witwatersrand.2 Initial generic supplies are expected to reach countries by the end of 2026.2

What You Need to Know

The FDA granted tentative approval to Dr. Reddy’s generic twice-yearly lenacapavir for HIV PrEP, the first generic version of the drug, for 120 low- and middle-income countries at about $40 per person per year.

The tentative approval came 16 months after Gilead’s originator was approved, and first generic supplies are expected to reach countries by the end of 2026.

Compared with daily oral FTC/TDF, lenacapavir reduced the risk of HIV by 100% in PURPOSE 1 and by 89% in PURPOSE 2, but experts caution that low prices alone won’t be enough without health systems ready to deliver it.

The partners are coordinating rollout with national governments, the Global Fund, the US Bureau of Global Health Security and Diplomacy, the Gates Foundation, and community groups.2 According to CHAI CEO Neil Buddy Shah, MD, more than 125,000 people in Africa have already started on lenacapavir.2

“This should be the new standard for global health,” Shah said in a statement, citing the 16-month gap between originator and generic approval.2

What PURPOSE 1 and PURPOSE 2 Showed for Twice-Yearly Lenacapavir PrEP

As Contagion has reported, twice-yearly lenacapavir outperformed daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). It reduced the risk of incident HIV by 100% in PURPOSE 1 and by 89% in PURPOSE 2.3 Injection site reactions were the most common adverse effect, occurring in 83.2% and 68.8% of lenacapavir recipients in the two trials, and most were mild.3

Adherence data are especially relevant where daily oral PrEP uptake has lagged. In PURPOSE 1 (NCT05568355), more than 90% of women received their lenacapavir injections on time. Only 4% of daily oral PrEP users achieved high and sustained adherence, Jared Baeten, MD, PhD, senior vice president of clinical development at Gilead, told Contagion.4

Baeten also emphasized oral daily PrEP remains appropriate for many patients, with the clinical goal being expanded choice.5 Gilead has since submitted a once-weekly oral lenacapavir formulation for PrEP to the FDA.4

Delivery remains a hurdle. Saiqa Mullick, PhD, director of implementation science at Wits RHI, cautioned “an affordable drug alone is not enough.” She added countries need health systems ready to deliver new prevention options.2

The approval comes as global prevention programs absorb funding cuts. According to UNAIDS data, people receiving PrEP at least once across 62 countries fell from 3.3 million in 2024 to 2.1 million in 2025.2 New HIV infections declined to approximately 1.2 million in 2025.2

REFERENCES
  1. US FDA approves first generic injectable lenacapavir for HIV prevention. News release. Unitaid. November 2, 2026. Accessed November 3, 2026. https://unitaid.org/news-blog/u-s-fda-approves-first-generic-injectable-lenacapavir-for-hiv-prevention/
  2. Lutton L. FDA tentatively approves first generic lenacapavir for HIV prevention in lower-income countries. Managed Healthcare Executive. November 2, 2026. Accessed November 3, 2026. https://www.managedhealthcareexecutive.com/view/fda-tentatively-approves-first-generic-lenacapavir-for-hiv-prevention-in-lower-income-countries
  3. Lai J, Pandit NS. Prospective game changer: lenacapavir for HIV preexposure prophylaxis. Contagion. January 12, 2026. https://www.contagionlive.com/view/prospective-game-changer-lenacapavir-for-hiv-preexposure-prophylaxis
  4. Baeten J, Hoffman M. Lenacapavir and the future of HIV prevention: PURPOSE trials, long-acting PrEP, and what comes next. Contagion. June 29, 2026. https://www.contagionlive.com/view/lenacapavir-hiv-prevention-purpose-trials-long-acting-prep
  5. Hoffman M. HIV in 2026: four experts on aging, testing, equity, and prevention’s next era. Contagion. July 2, 2026. https://www.contagionlive.com/view/hiv-2026-four-experts-aging-testing-equity-prevention

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