FDA Approves Generic HIV Prevention Shot for 120 Countries

A major step toward expanding access to HIV prevention came on November 2, 2026, when the US Food and Drug Administration approved a generic version of lenacapavir. The twice-yearly injection is expected to become available at an affordable price in 120 low- and middle-income countries.

According to the organizations involved in its development, the generic medication is expected to cost approximately $40 per person annually in eligible countries. This matches the price of existing daily HIV prevention pills while requiring significantly fewer doses.

Lenacapavir demonstrated nearly complete protection against new HIV infections in two groundbreaking studies involving people at high risk. Its twice-yearly administration could also address adherence challenges associated with daily preventive medication.

Carmen Pérez Casas, HIV lead at global health agency Unitaid, highlighted the importance of reducing dependence on daily medication.

"People don't always take their daily dose of medication, and if you do not take it, you cannot get protected against HIV," said Carmen Pérez Casas.

She expressed greater confidence in the potential of the injectable treatment to improve prevention efforts.

"With lenacapavir, we are much more hopeful."

According to the World Health Organization, approximately 41 million people worldwide were living with HIV last year, while 570,000 died from HIV-related causes.

Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said affordable generic production could expand access to preventive treatment for millions of people.

"We could help to scale this to the 20 million people around the world who need PrEP," said Carolyn Amole.

She emphasized that broader access could significantly change the global response to HIV.

"And if we scale to those levels," she added.

Amole continued by describing the potential impact of reaching that target population.

"We can actually begin to bring an end to the HIV epidemic."

However, the generic medication cannot currently be sold in the United States because the original branded version, Yeztugo, remains protected by a patent held by Gilead Sciences. The company received approval for its branded product last year, with a US list price of $28,218 annually before insurance.

The FDA granted the generic product tentative approval under an established program that evaluates the quality of HIV-related medicines intended for distribution in other countries through US government-supported initiatives. This designation allows the product to receive regulatory recognition while the original manufacturer's patent remains in effect.

Gilead had previously been the sole supplier of lenacapavir, and demand in low- and middle-income countries exceeded available supplies. Last year, the company established royalty-free licensing agreements with six generic manufacturers covering selected countries in sub-Saharan Africa, Asia and Latin America.

A Gilead spokesperson said the company supported efforts to expand access to the medication.

"We share the sense of urgency around expanding access to lenacapavir for HIV prevention," said a Gilead spokesperson.

The spokesperson also described the company's licensing arrangements as a way to support broader and sustainable distribution.

"We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV."

The newly approved generic was developed by India-based Dr. Reddy's Laboratories through an agreement coordinated by Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute.

Despite its potential benefits, lenacapavir requires medical screening before treatment begins. Common side effects include injection-site reactions, headaches and nausea. HIV testing is also necessary before starting treatment and before each subsequent injection because resistance has been identified in people who received the medication while having an undiagnosed HIV infection.

Saiqa Mullick, director of implementation science at Wits RHI, emphasized the importance of testing before preventive treatment.

"For any kind of PrEP … you need to have HIV testing in advance," said Saiqa Mullick.

She explained that rapid testing is an available option in many low- and middle-income countries.

Generic lenacapavir could begin reaching some countries within weeks, according to the organizations involved. However, distribution may take longer in countries requiring separate national regulatory approval.

Amole said additional financial resources and distribution efforts remain necessary to reach the intended population.

"The work is not done. Now, we need the funding to actually buy it for everyone who needs it and then we need to do the hard work of getting it to the millions of people who need it and want it," said Carolyn Amole.

She described the FDA decision as an important development in expanding access to HIV prevention.

"But this is a great milestone."

Pérez Casas also pointed to the importance of combining scientific progress with political commitment and financial support.

She said scientific advances have created new opportunities to strengthen the global response to HIV.

"Now," she said.

Her final remarks emphasized the availability of new prevention options.

"We have the tools."