Lenacapavir: Dr. Reddy’s Wins FDA Tentative Approval for a $40-a-Year HIV Prevention Shot

Dr. Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for generic lenacapavir, an injection that protects against HIV (human immunodeficiency virus) with just two doses a year. In two Phase 3 trials, at least 99.9% of people who received the original drug stayed HIV-negative. The partners announced the approval on 2 November 2026. Under an agreement with global health partners, Dr. Reddy’s will supply the generic at US$40 per person per year in 120 low- and middle-income countries, and the partners expect the first supplies before the end of 2026.

In fact, the speed matters as much as the price. Generic versions of breakthrough medicines usually take many years to reach poorer countries. This one received FDA tentative approval 16 months after the FDA approved the original drug in the US.

Note: This article is for information only and is not medical advice. Generic lenacapavir has tentative FDA approval only: it cannot be sold in the US, and each country must approve it before use. PrEP should be started only under a clinician’s care, after a negative HIV test.

Generic Lenacapavir: The News in Brief

• What: First FDA tentative approval for a generic lenacapavir injection for HIV prevention.
• Who: Dr. Reddy’s Laboratories, supported by Unitaid (a global health partnership hosted by the WHO), the Clinton Health Access Initiative (CHAI) and Wits RHI of the University of the Witwatersrand, South Africa.
• Price: US$40 per person per year (the agreed supply price) in the 120 countries covered by Gilead’s voluntary licence. The brand-name drug lists at about US$28,000 a year in the US.
• When: First supplies before the end of 2026; wider availability in 2027.

What Is Lenacapavir and How Does It Work?

Gilead Sciences invented and developed lenacapavir, and sells it in the US under the brand name Yeztugo. Dr. Reddy’s has developed and will make a generic version under a licence from Gilead. Lenacapavir is a capsid inhibitor, a newer class of HIV drug.

The capsid is the protein shell that holds the virus’s genetic material. HIV needs it at several stages of its life cycle, including reaching the cell’s nucleus and building new virus particles. Lenacapavir binds to the capsid and disrupts these steps, so the virus cannot multiply.

Read also: New Human Genes Controlling HIV Infection Identified By Gladstone Scientists

The drug also stays in the body for a long time. That is why a single injection under the skin can protect for about six months. PrEP, short for pre-exposure prophylaxis, means using medicine before exposure to stop infection. A person must test HIV-negative before starting, because using it during an undiagnosed infection can lead to drug resistance.

How Well Does Lenacapavir Work?

The FDA approved Gilead’s original product in June 2025 on the strength of two large Phase 3 trials:

• PURPOSE 1: Among 2,134 women in South Africa and Uganda who received lenacapavir, not a single HIV infection occurred. It also outperformed the daily oral PrEP pill Truvada.
• PURPOSE 2: Among 2,179 men and gender-diverse people who received lenacapavir, there were two infections, so 99.9% stayed HIV-negative.

Why a “Tentative” Approval for Generic Lenacapavir Still Matters

The FDA gives a generic tentative approval when the drug meets all its quality, safety and efficacy standards but cannot yet be sold in the US, because the original drug is still protected by patents or exclusivity. The FDA granted Dr. Reddy’s approval under PEPFAR, the US government’s global HIV programme. It allows the US government to buy the generic for supply abroad, and Unitaid, CHAI and Wits RHI are working with national governments and the Global Fund to bring it into countries, and many national regulators can rely on the FDA’s review to speed up their own approvals.

How the Wait Shrank to 16 Months

Three moves made the speed possible:

• Early licensing: Starting in late 2024, Gilead gave voluntary licences to six generic manufacturers, including Dr. Reddy’s.
• An early price deal: In September 2025, Unitaid, CHAI and Wits RHI agreed the US$40 price with Dr. Reddy’s and supported its development with funding, technical help and regulatory guidance.
• A smart filing strategy: Doctors use lenacapavir both to prevent and to treat HIV. Dr. Reddy’s combined both uses in one application through the FDA’s 505(b)(2) pathway, and the FDA granted it priority review, which aims for a decision within six months.

In addition, Unitaid’s Executive Director, Dr. Philippe Duneton, says early risk-taking by global health partners is closing the gap between scientific breakthroughs and access in poorer countries. For lenacapavir, that gap is now just over a year. Dr. Shah calls the 16-month timeline a model for global health.

What $40 a Year for Generic Lenacapavir Changes

Daily PrEP pills already exist, but taking a pill every day is hard for many people, and missed doses reduce protection. Two injections a year remove the need for a daily pill. CHAI’s chief executive, Dr. Neil Buddy Shah, notes that twice-yearly injections are far easier for people at risk than a daily pill.

However, price decides whether that convenience reaches people. Unitaid says the US$40 price is in line with daily oral PrEP, which it describes as a key condition for wide use in low- and middle-income countries. For comparison, the brand-name drug Yeztugo lists at about US$28,000 a year in the US. Meanwhile, demand is already strong: according to Unitaid, more than 125,000 people in 10 African countries have started Gilead’s lenacapavir, even before the generic is available.

A Milestone for Indian Pharma

Long-acting injectables are among the most difficult medicines to make. Producing one at such a low price demands advanced formulation science, strict quality control and large-scale manufacturing. Deepak Sapra, CEO of API and Services at Dr. Reddy’s, said that making such a complex injectable affordable took scientific capability, manufacturing expertise and scale, and called the approval a moment of pride for the company.

For life-science students, the approval highlights the skills that complex generic medicines depend on: formulation development, regulatory affairs, quality assurance and manufacturing science. Students interested in these areas can follow openings at Indian companies working on complex generics, for example on the Dr. Reddy’s careers page, and browse current roles.

What Happens Next for Generic Lenacapavir

The FDA decision gives countries a strong base for their own national approvals and faster rollout. The first doses should arrive before the end of 2026, with broader supply in 2027. Prof. Saiqa Mullick, Director of Implementation Science at Wits RHI, cautions that an affordable drug alone is not enough: health systems need to be ready, providers need to be confident, and communities need to be involved.

The Bigger Picture

For years, the biggest obstacle in HIV prevention has not been the science. It has been getting proven tools to people quickly and at a price health systems can pay. The PURPOSE 1 and 2 trials proved that lenacapavir works, and Gilead’s invention now has a licensed generic, made by an Indian company, with a US$40 price. That gap is closing in months instead of years. Still, the harder task now is the rollout.

Generic Lenacapavir: Quick Facts

FAQs

Is generic lenacapavir available in India or the US?

Not yet. It cannot be sold in the US because the original drug is still protected there, and every country, including India, needs its own regulatory approval before use.

How often is lenacapavir given?

Once every six months, as an injection under the skin, after a negative HIV test.

Why is the approval called “tentative”?

The generic meets the FDA’s quality, safety and efficacy standards, but patents or exclusivity on the original drug block US sales. However, governments can still buy it for supply in other countries.

How much will generic lenacapavir cost?

US$40 per person per year in the 120 low- and middle-income countries covered by Gilead’s licence, under an agreement with Unitaid, CHAI and Wits RHI.