Medically Reviewed: 6 October 2026 • Last Updated: 6 October 2026 • 9 minute read
The twice-yearly HIV prevention injection is not yet approved for sale in India. Here is what is known about its cost and timeline.
A medicine that prevents HIV with two injections a year sounds almost too convenient, which is why so many people in India are searching for its price. Lenacapavir is approved in the United States and the European Union, and the World Health Organization recommends it as an additional PrEP option.
What has not happened is approval in India. That single fact shapes everything below. There is no official price here yet, only announced figures and a regulatory file still in motion. This page keeps those two things apart.
Quick Answer
- As of 8 October 2026 there is no official lenacapavir price in India, because the medicine is not yet approved for marketing here.
- Generic supply has been announced at about 40 US dollars per person per year for eligible low and middle income countries from 2027. That is not a confirmed Indian retail price.
- An expert committee recommended waiving local trials in August 2026. Final approval from the DCGI is still pending.
- Lenacapavir prevents HIV. It is given twice a year, it is not a vaccine, and it does not cure HIV.
Lenacapavir Price in India: What Is Expected
There is no official Indian price yet. Anyone quoting a confirmed MRP today is guessing, and marketplace listings are not an approved supply route for a prescription HIV medicine.
What we do know comes from the licensing arrangements. Gilead, which developed lenacapavir, signed royalty-free voluntary licences with six generic manufacturers, including Dr Reddy’s Laboratories, Emcure and Hetero, covering 120 mostly low and middle income countries.
In September 2025, Dr Reddy’s and Hetero announced supply at about 40 US dollars per person per year for eligible low and middle income countries from 2027, with financial and technical support from Unitaid, the Clinton Health Access Initiative, Wits RHI and the Gates Foundation. That is an announced supply price, not an Indian pharmacy price. For comparison, see how a new once-weekly insulin was priced at launch.
| Market | Reported cost per year |
|---|---|
| United States, branded | About 28,000 US dollarsReported US annual price for the branded product |
| Generic supply, low and middle income countries | About 40 US dollars, roughly 3,500 rupeesAnnounced supply price from 2027. Not an Indian MRP or a confirmed patient price. |
| India, retail pharmacy | Not announcedDepends on approval, manufacturer pricing and government procurement |
Four different numbers get confused here. An announced supply price, an Indian MRP, a pharmacy selling price and a government procurement price are not the same thing. Only the first exists today. If supply runs through the national HIV programme rather than pharmacies, individual cost may not follow a pharmacy price at all. Our medical test prices in India section tracks verified figures for other tests and treatments.
When Will the HIV Injection Be Available in India?
India’s approval process moved forward in 2026, but it has not finished. At a Subject Expert Committee meeting on 11 August 2026, the panel reviewed proposals from Dr Reddy’s and Emcure to market lenacapavir injection in India and recommended waiving local Phase 3 trials and bioequivalence studies. That removes some of the local study requirements that would otherwise form part of the approval process.
A recommendation is not permission to sell, and the difference matters. The Drugs Controller General of India still has to grant marketing authorisation. The committee also specified that a person must test negative for HIV-1 before starting, and that both companies must submit Phase 4 study protocols within three months of authorisation.
One limit is easy to miss. The recommendation covers HIV prevention only. The committee did not extend the same waiver to lenacapavir used as treatment for heavily treatment-experienced people with multidrug-resistant HIV, saying the evidence on how the drug behaves in the body and across ethnic groups was not adequate. Any Indian marketing authorisation would be assessed separately for each proposed indication. This is the same stage another closely watched drug awaiting DCGI approval is sitting at.
Approval Progress, Stage by Stage
| Stage | Status |
|---|---|
| US FDA approval for prevention | Approval granted, June 2025 |
| European Union marketing authorisation | Authorisation granted, 25 August 2025Brand name Yeytuo, per the EMA record |
| WHO recommends it as a PrEP option | Recommendation issued, July 2025 |
| Indian expert committee recommends trial waiver | Recommendation issued, August 2026 |
| DCGI marketing authorisation | Pending |
| Indian launch and price announcement | Not announcedGeneric supply indicated for 2027 |
Marketing authorisation and a launch by the manufacturer are both needed before anyone can get this medicine through an approved Indian route. Authorisation on its own does not mean immediate nationwide availability or a settled patient price. Approval is also not a countdown, so no one can put a reliable date on it. This page is updated when the position changes, so check the review date at the top.
What Is Lenacapavir?
Lenacapavir is an antiretroviral medicine from a newer group called capsid inhibitors. HIV has a protein shell called the capsid, which surrounds its genetic material and helps the virus complete its life cycle. Lenacapavir interferes with that shell at several stages, so the virus cannot multiply.
It is used in two very different ways, and mixing them up causes most of the confusion online. The first is prevention, called pre-exposure prophylaxis or PrEP, sold as Yeztugo in the United States and Yeytuo in Europe. The second is treatment for people already living with drug-resistant HIV, sold as Sunlenca. This article is about lenacapavir for HIV prevention.
A Common Misconception: Is Lenacapavir an HIV Vaccine?
No, and this is worth saying plainly, because many people search for it as an HIV vaccine or an HIV injection.
A vaccine trains your immune system to recognise an infection, and that protection can last years. Lenacapavir does nothing of the kind. It sits in your body at a protective level for about six months and blocks the virus directly. When the drug level falls, protection falls with it. No HIV vaccine is licensed anywhere. Think of it as a long-acting preventive medicine, not immunisation.
Patient Tip
If a seller calls this an HIV vaccine, or offers to supply it in India today, treat that as a warning about the seller. There is no approved retail supply route in India yet.
How Well Does Lenacapavir Work?
This is high-certainty evidence from two published Phase 3 trials, not manufacturer marketing.
- PURPOSE 1, in adolescent girls and young women in South Africa and Uganda, reported no HIV infections among 2,134 participants given lenacapavir.
- PURPOSE 2, in men and gender-diverse participants, reported two infections in the lenacapavir group. HIV incidence was 96 percent lower than the background rate and 89 percent lower than in the daily tablet group.
Both trials were published in the New England Journal of Medicine and both compared lenacapavir against a daily oral PrEP tablet. On this evidence, the World Health Organization recommended twice-yearly lenacapavir as an additional PrEP option in July 2025.
One limit is worth knowing. Studies in other groups, including people who inject drugs, are still running, so the strongest evidence applies to the populations in those two trials.
Who It Is For, and Who It Is Not For
Lenacapavir for prevention is for adults and adolescents who do not have HIV but face a real chance of exposure. Abroad the approved indication covers adolescents weighing at least 35 kilograms.
It is not appropriate for someone who already has HIV. Starting a prevention medicine while unknowingly living with undiagnosed HIV is the main safety concern with any PrEP product, which is why a confirmed negative test before starting, and repeat testing before each dose, is part of the protocol. A routine complete blood count does not replace a dedicated HIV test. It also does not protect against other sexually transmitted infections or pregnancy.
How the Injection Is Given
The starting course begins on day 1 with two injections under the skin plus oral tablets, followed by oral tablets on day 2. This brings drug levels up quickly. After that, each maintenance dose is two injections under the skin of the abdomen at a single visit, every six months. It is not self-administered. A trained healthcare professional must give the injections, and incorrect technique has been linked to serious injection site reactions. Whether this medicine is suitable for you is your doctor’s decision.
Side Effects and Safety
Injection site reactions are common rather than rare. In PURPOSE 1 they affected about 69 percent of the lenacapavir group against about 35 percent of those given placebo injections. They include pain, swelling, redness and small firm lumps under the skin called nodules. Most were manageable, and very few people stopped treatment because of them. Nausea and headache were also reported.
The more serious concern is improper administration. Injecting into the skin rather than under it has been linked to severe reactions, including skin breakdown. Because lenacapavir stays in the body for months, levels fall slowly after stopping. If someone acquires HIV while those levels are falling, there is a risk of the virus becoming resistant to the medicine. Stopping should therefore be planned with a doctor, not handled by simply missing the next appointment.
Medicines That Interfere With It
The European product information lists medicines that must not be taken with lenacapavir because they lower its level in the body, including rifampicin, carbamazepine, phenytoin and the herbal product St John’s wort. Rifampicin matters particularly in India, where it is a standard part of TB treatment. Tell your doctor every medicine and supplement you take before starting.
When to See a Doctor
Speak to a doctor if you have had a possible exposure, if a partner is living with HIV, or if you want to know whether PrEP suits you.
Keep in Mind: Act Urgently
- Possible HIV exposure in the last 72 hours. Go to a hospital or HIV clinic today. Post-exposure prophylaxis is a different, time-sensitive treatment and should be started as soon as possible after exposure.
- Fever, rash, sore throat and swollen glands a few weeks after a possible exposure. Get tested, do not wait it out. The same symptoms appear in many other viral illnesses, which is exactly why a test settles it and guesswork does not.
- An injection site that turns increasingly painful, hot or hard, or develops an open sore. Have it seen the same day.
Illustrative Scenario
A 31-year-old reads about a twice-yearly HIV injection and asks whether to wait for it. His doctor explains it is not approved here, tests him, finds him negative, and starts an available PrEP option with a review date. If lenacapavir becomes available later, his doctor can review whether changing PrEP is appropriate. Waiting without another prevention plan could have left him without PrEP protection.
Composite example, not a specific patient.
What to Do Next
- If you need HIV prevention now, book a doctor’s appointment and ask about PrEP options available today. Do not wait for lenacapavir.
- Get an HIV test before starting any PrEP, and keep testing on schedule afterwards.
- Be very cautious about anyone offering lenacapavir for sale in India. There is no approved supply route here until marketing authorisation is granted.
- Treat the announced 40 US dollar a year figure as a 2027 supply price, not an Indian pharmacy price. More in our infectious diseases section.
Frequently Asked Questions
What is the lenacapavir price in India right now?
There is no official Indian price yet. Generic supply has been announced at about 40 US dollars per person per year for eligible low and middle income countries from 2027. That is not a confirmed Indian retail price.
Is lenacapavir available in India?
Not for sale. An expert committee recommended waiving local trials in August 2026, but marketing authorisation from the Drugs Controller General of India is still pending.
Does lenacapavir cure HIV?
No. Nothing cures HIV. Lenacapavir either helps prevent infection in people who do not have HIV, or forms part of treatment for drug-resistant HIV. Those are two different products and two different situations.
Will I need an HIV test before every injection?
Yes. Testing negative before starting and before each repeat dose is part of the protocol, and the Indian expert committee specifically required a negative HIV-1 test before starting.
How often is lenacapavir given for HIV prevention?
Every six months, after a short starting course that includes tablets. Each maintenance dose consists of two injections given under the skin of the abdomen by a healthcare professional.
What are the common side effects of lenacapavir?
Injection site reactions are common, affecting about 69 percent of participants in one trial. They include pain, swelling, redness and small nodules. Nausea and headache were also reported.
Why will lenacapavir cost so much less in India than in the United States?
Gilead granted royalty-free voluntary licences to several generic manufacturers, including Indian companies, for supply to 120 low and middle income countries. That licensing arrangement, backed by global health funders, is what allows a planned price far below the branded US product.
What if someone is late for the six-month injection?
Keep the appointment on schedule where possible. Anyone expecting to be more than about two weeks late should contact their doctor promptly rather than wait. A temporary oral option exists in some situations, but the right plan depends on the circumstances and is a decision for the treating doctor.
References
- Guidelines on Lenacapavir for HIV Prevention. World Health Organization (2025). who.int
- Bekker LG, et al. Twice-Yearly Lenacapavir in Cisgender Women. NEJM (2024). nejm.org
- Twice-Yearly Lenacapavir in Men and Gender-Diverse Persons. NEJM (2025). nejm.org
- Lenacapavir Drug Record. Clinicalinfo, US Department of Health and Human Services (2026). clinicalinfo.hiv.gov
- Yeytuo (lenacapavir) Public Assessment Report. European Medicines Agency (2025). ema.europa.eu
- SEC (Antimicrobial and Antiparasitic) recommendations, 11 August 2026. Central Drugs Standard Control Organisation (2026).
- Lenacapavir at 40 US dollars per person per year. Unitaid, CHAI and Dr Reddy’s (2025). clintonhealthaccess.org
- CDSCO Panel Nod for Lenacapavir PrEP Waivers. Medical Dialogues (2026). medicaldialogues.in
Written By
Iraphan Khan, BSN, RN, D.Pharm, Public Health Researcher. Iraphan writes RealMedVision’s medicine and diagnostics coverage.
Medically Reviewed By
Dr Praveen Verma, MBBS, MD (Pathology) and Dr Himanshu Morya, MBBS, Medical Educator. Reviewed 8 October 2026.
Disclaimer
This article is general education, not medical advice, a diagnosis or a prescription. Lenacapavir is not approved for marketing in India at the time of writing. Prices are reported figures from the listed sources and are not an offer of sale. Always consult a qualified doctor about HIV prevention, testing and treatment.