Rachel V Thomas

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US FDA Approves Dr Reddy's Generic HIV Prevention Shot: What Cheaper Lenacapavir Means For India, Other Countries

The US Food and Drug Administration (<span>FDA</span>) has granted tentative approval to Dr. Reddy's Laboratories for the first generic version of <span>lenacapavir</span>, a long-acting injectable for <span>HIV</span> prevention. The development raises hopes of making HIV prevention more affordable in 120 low- and middle-income countries, including India.

The approval is considered “tentative”, the FDA’s standard designation for generics while the originator remains under patent.

The development comes just 16 months after <span>Gilead Sciences</span> received approval for its original product, marking one of the fastest timelines for a major <a href="https://www.healthandme.com/health/hiv-human-immunodeficiency-disease" data-type="tilCustomLink">HIV </a> innovation.

Lenacapavir is the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option for HIV prevention. Dr. Reddy's generic injection is expected to cost US$40 per person annually across the 120 eligible countries, with initial supplies expected by the end of 2026.

Calling it “a moment of immense pride”, Deepak Sapra, Chief Executive Officer, API and Services, at Dr. Reddy's, said the FDA approval validates the company's efforts to expand access to twice-yearly HIV prevention across low- and middle-income countries.

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/south-africa-receives-1st-batch-of-hiv-prevention-medicine-lenacapavir-article-154024529" data-type="tilCustomLink">South Africa Receives 1st Batch Of HIV Prevention Medicine Lenacapavir</a>

<h2>Dr Reddy's First Of 6 Generic Drugmakers To Get FDA Nod</h2>

In October 2024, Gilead Sciences signed voluntary licensing agreements with six generic manufacturers to produce and supply low-cost versions of lenacapavir in 120 low- and middle-income countries.

<ul><li>Dr. Reddy's Laboratories (India)</li><li>Emcure Pharmaceuticals (India)</li><li>Hetero Labs (India)</li><li>Eva Pharma (Egypt)</li><li>Ferozsons Laboratories (Pakistan)</li><li>Mylan (a subsidiary of Viatris)</li></ul>

Dr. Reddy's is the first among the six licensees to receive tentative US FDA approval. The other five companies are at various stages of product development, bioequivalence testing and regulatory filing.

<h2>What Will Cheaper Lenacapavir Mean For India?</h2>

At its August 11, 2026, meeting, the Indian drug regulator's Subject Expert Committee recommended waiving local Phase III clinical trials and bioequivalence studies for generic injectable lenacapavir applications submitted by Dr. Reddy's and Emcure Pharmaceuticals for PrEP.

The proposed price of approximately US$40 per person annually could make twice-yearly HIV prevention more accessible.

However, this is an indicative price for generic supplies, not a confirmed retail price in India. The eventual Indian price will depend on regulatory approval, manufacturing costs, supply capacity, competition and distribution.

<strong>Read More</strong>: <a href="https://www.healthandme.com/health-wellness/exclusive-with-leading-hiv-expert-whats-driving-rising-hiv-cases-among-young-people-and-how-to-prevent-it-article-156121437" data-type="tilCustomLink">Exclusive With Leading HIV Expert: What's Driving Rising HIV Cases Among India's Youth And How To Prevent It</a>

<h2>What Does The Approval Mean For HIV Prevention?</h2>

Generic lenacapavir could offer people at risk of HIV an alternative to daily oral PrEP pills. Its twice-yearly dosing may help those who struggle with daily medication adherence or face stigma and barriers to healthcare access.

“For someone at risk of HIV, taking a pill every day to prevent a disease they do not have is a hard thing to ask. Two injections a year of a product that is almost 100% effective at preventing HIV changes that entirely.”

“Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough,” said Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand, which partnered with Dr. Reddy's.

#shorts Once-Weekly HIV Pill Shows Promise

Lenacapavir is a long-acting antiretroviral drug developed by Gilead. For HIV prevention, it is administered as two injections in the abdomen, providing protection for six months.

People must test negative for HIV before receiving it. The drug does not treat existing HIV infections or prevent other sexually transmitted infections. 

Two major clinical trials demonstrated its high efficacy. In one study involving adolescent girls and young women in South Africa and Uganda, there were zero new HIV infections among participants who received lenacapavir. A second trial involving gay men and gender-diverse individuals also demonstrated high efficacy with twice-yearly injections.

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The US Food and Drug Administration (FDA) has granted tentative approval to Dr. Reddy's Laboratories for the first generic version of lenacapavir, a long-acting injectable for HIV prevention. The development raises hopes of making HIV prevention more affordable in 120 low- and middle-income countries, including India.The approval is considered “tentative”, the FDA’s standard designation for generics while the originator remains under patent.The development comes just 16 months after Gilead Sciences received approval for its original product, marking one of the fastest timelines for a major HIV  innovation.Lenacapavir is the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option for HIV prevention. Dr. Reddy's generic injection is expected to cost US$40 per person annually across the 120 eligible countries, with initial supplies expected by the end of 2026.Calling it “a moment of immense pride”, Deepak Sapra, Chief Executive Officer, API and Services, at Dr. Reddy's, said the FDA approval validates the company's efforts to expand access to twice-yearly HIV prevention across low- and middle-income countries.Also read: South Africa Receives 1st Batch Of HIV Prevention Medicine LenacapavirDr Reddy's First Of 6 Generic Drugmakers To Get FDA NodIn October 2024, Gilead Sciences signed voluntary licensing agreements with six generic manufacturers to produce and supply low-cost versions of lenacapavir in 120 low- and middle-income countries.The six manufacturers are:Dr. Reddy's Laboratories (India)Emcure Pharmaceuticals (India)Hetero Labs (India)Eva Pharma (Egypt)Ferozsons Laboratories (Pakistan)Mylan (a subsidiary of Viatris)Dr. Reddy's is the first among the six licensees to receive tentative US FDA approval. The other five companies are at various stages of product development, bioequivalence testing and regulatory filing.What Will Cheaper Lenacapavir Mean For India?At its August 11, 2026, meeting, the Indian drug regulator's Subject Expert Committee recommended waiving local Phase III clinical trials and bioequivalence studies for generic injectable lenacapavir applications submitted by Dr. Reddy's and Emcure Pharmaceuticals for PrEP.The proposed price of approximately US$40 per person annually could make twice-yearly HIV prevention more accessible.However, this is an indicative price for generic supplies, not a confirmed retail price in India. The eventual Indian price will depend on regulatory approval, manufacturing costs, supply capacity, competition and distribution.Read More: Exclusive With Leading HIV Expert: What's Driving Rising HIV Cases Among India's Youth And How To Prevent ItWhat Does The Approval Mean For HIV Prevention?Generic lenacapavir could offer people at risk of HIV an alternative to daily oral PrEP pills. Its twice-yearly dosing may help those who struggle with daily medication adherence or face stigma and barriers to healthcare access.“For someone at risk of HIV, taking a pill every day to prevent a disease they do not have is a hard thing to ask. Two injections a year of a product that is almost 100% effective at preventing HIV changes that entirely.”“Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough,” said Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand, which partnered with Dr. Reddy's.Lenacapavir: How Does It Work?   Lenacapavir is a long-acting antiretroviral drug developed by Gilead. For HIV prevention, it is administered as two injections in the abdomen, providing protection for six months.People must test negative for HIV before receiving it. The drug does not treat existing HIV infections or prevent other sexually transmitted infections. Two major clinical trials demonstrated its high efficacy. In one study involving adolescent girls and young women in South Africa and Uganda, there were zero new HIV infections among participants who received lenacapavir. A second trial involving gay men and gender-diverse individuals also demonstrated high efficacy with twice-yearly injections.

us fda approves dr reddy's generic hiv prevention shot: what cheaper lenacapavir means for india, other countries

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US FDA Approves Dr Reddy's Generic HIV Prevention Shot: What Cheaper Lenacapavir Means For India, Other Countries

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US FDA Approves Dr Reddy's Generic HIV Prevention Shot: What Cheaper Lenacapavir Means For India, Other Countries

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