The US Food and Drug Administration (FDA) has granted tentative approval to Dr. Reddy's Laboratories for a generic version of injectable lenacapavir, Gilead's twice-yearly HIV prevention shot. Unitaid and the Clinton Health Access Initiative (CHAI) call it the first generic injectable lenacapavir. It targets 120 low- and middle-income countries at USD 40 per person per year.
The news was announced on 2 November 2026. Tentative approval does not allow the generic to be sold in the United States while Gilead's patents remain in force. It does mean the FDA has reviewed the product, and it opens the way for purchase by US government programmes and for supply abroad. In Ireland, the HSE's free PrEP programme still relies on daily or event-based tablets.
- Decision: FDA tentative approval for Dr. Reddy's generic lenacapavir injection, announced 2 November 2026.
- Price: USD 40 per person per year in the 120 countries covered by Gilead's voluntary licence, according to Unitaid and CHAI.
- Timing: First supplies expected in countries before the end of 2026, with broader availability in 2027.
- Speed: The decision came 16 months after the FDA approved Gilead's own product in June 2025.
- EU brand: Gilead's lenacapavir for PrEP is authorised in the EU as Yeytuo since 25 August 2025.
- Ireland: No NCPE assessment of Yeytuo was listed at the time of writing.
What did the FDA decide?
Dr. Reddy's received tentative approval for its generic lenacapavir, a long-acting injection given twice a year to reduce the risk of sexually acquired HIV-1. Business Standard reported that the approval was granted under the FDA's President's Emergency Plan for AIDS Relief (PEPFAR) programme. According to the same report, the product is intended for adults and adolescents weighing at least 35 kg.
Unitaid and CHAI describe tentative approval as "the FDA's standard designation for generics while the originator remains under patent". They say it also enables procurement by the US government.
According to Unitaid, Dr. Reddy's combined the prevention and treatment uses of lenacapavir in one application. It was filed through the FDA's 505(b)(2) pathway and received priority review, which targets a decision within six months.
Is this the first generic lenacapavir?
Unitaid and CHAI say Dr. Reddy's "secured FDA tentative approval for the first generic injectable lenacapavir". We did not find a public record of tentative approval for any other generic maker at the time of writing. Gilead signed royalty-free, non-exclusive licences with six manufacturers on 2 October 2024. These were Dr. Reddy's, Emcure, Eva Pharma, Ferozsons, Hetero and Mylan, a Viatris subsidiary. The regulatory status of the other five licensees' products has not been disclosed in the sources we reviewed.
| Date | Event |
|---|---|
| 2 October 2024 | Gilead signs voluntary licences with six generic makers for 120 countries |
| 18 June 2025 | FDA approves Gilead's Yeztugo for HIV prevention in the US |
| 14 July 2025 | WHO recommends injectable lenacapavir as an additional PrEP option |
| 25 August 2025 | European Commission authorises Gilead's Yeytuo in the EU |
| September 2025 | USD 40 per year pricing agreement announced by Unitaid, Wits RHI, CHAI and Dr. Reddy's |
| 2 November 2026 | FDA tentative approval for Dr. Reddy's generic lenacapavir |
What will the generic cost and who will get it?
Under an agreement announced in September 2025, the generic will cost USD 40 per person per year in the 120 low- and middle-income countries covered by Gilead's voluntary licence. Unitaid, Wits RHI (the Wits Reproductive Health and HIV Institute) and CHAI provided financial, technical and regulatory support to Dr. Reddy's.
Unitaid says more than 125,000 people in 10 early-adopter African countries have already started Gilead's lenacapavir. Business Standard noted that wider supply also depends on further steps, including WHO prequalification and approval by national regulators in each country.
Deepak Sapra, Chief Executive Officer, API and Services, at Dr. Reddy's, said: "The U.S. FDA approval validates that work."
How does lenacapavir work as PrEP?
Pre-exposure prophylaxis (PrEP) is medicine taken by people who do not have HIV to lower their risk of getting it. According to the European Medicines Agency (EMA), Yeytuo injections are given at the start of treatment and every six months after that, together with tablets on days 1 and 2. A doctor or nurse gives the injection under the skin of the abdomen or thigh. Gilead reported that 99.9% or more of participants who received the drug in its PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
What does this mean for Ireland?
The generic is not intended for Ireland. Gilead's licence covers 120 mostly low- and lower-middle-income countries. Gilead's branded product, Yeytuo, holds an EU marketing authorisation. The authorisation holder named by the EMA is Gilead Sciences Ireland Unlimited Company in Carrigtohill, Co Cork.
Ireland began its national HIV PrEP programme in November 2019. Free PrEP is available through HSE-approved services to people who meet clinical criteria. The HSE's public guidance describes PrEP tablets taken daily or around the time of sex, and does not mention injectable PrEP. According to the HSE Sexual Health Programme's 2024 report, 6,138 people received PrEP at least once in 2024, and 8,633 new users had accessed PrEP through the HSE since 2019.
The National Centre for Pharmacoeconomics (NCPE) had no assessment of Yeytuo listed at the time of writing. It did review Sunlenca, the lenacapavir brand for treating multidrug-resistant HIV. On 8 August 2025 the NCPE recommended that Sunlenca not be considered for reimbursement at the submitted price.
The Health Protection Surveillance Centre (HPSC) recorded 989 total HIV diagnoses in Ireland in 2024, of which 239 were first-time diagnoses.
Frequently asked questions
What is tentative approval?
It means the FDA has reviewed a generic medicine, but it cannot be sold in the US while the original brand is still protected by patents or exclusivity. Unitaid and CHAI say it allows procurement by the US government.
Can I get the USD 40 generic in Ireland?
No. The generic is licensed for 120 mostly low- and lower-middle-income countries under Gilead's voluntary licence. It is not intended for the Irish market.
Is injectable PrEP available on the HSE?
The HSE's PrEP pages describe tablet PrEP only. No NCPE assessment of Yeytuo was listed at the time of writing, and reimbursement has not been announced.
Should I change my HIV prevention?
This article is not medical advice. Talk to your GP or sexual health clinic about which HIV prevention option suits you.
Outlook
The next steps are WHO prequalification of the generic and national approvals in buying countries. For Ireland, the question is whether Gilead submits Yeytuo for an NCPE assessment and whether the HSE decides to fund it. We will report any update from the NCPE or HSE.
Sources
- Unitaid, U.S. FDA approves first generic injectable lenacapavir for HIV prevention, 2 November 2026
- Clinton Health Access Initiative, U.S. FDA approves first generic injectable lenacapavir for HIV prevention, 2 November 2026
- Business Standard, US FDA grants tentative nod to Dr Reddy's twice-yearly HIV prevention drug, 2 November 2026
- Gilead Sciences, Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers, 2 October 2024
- Gilead Sciences, Yeztugo (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection, 18 June 2025
- World Health Organization, WHO recommends injectable lenacapavir for HIV prevention, 14 July 2025
- European Medicines Agency, Yeytuo: EPAR, accessed 3 November 2026
- National Centre for Pharmacoeconomics, Lenacapavir (Sunlenca). HTA ID: 25047, 8 August 2025
- HSE, About PrEP and who can take it, accessed 3 November 2026
- HSE Sexual Health Programme, HIV Pre-Exposure Prophylaxis (PrEP) in Ireland: 2024 Report, May 2026
- Health Protection Surveillance Centre, HIV in Ireland, 2024, November 2025
Cover image: AI-generated illustration.
