Hyderabad: Indian pharmaceutical company Dr Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of lenacapavir, a long-acting HIV prevention medicine administered through injections twice a year.

The approval, granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR), marks an important step towards expanding access to affordable HIV prevention in low- and middle-income countries.

The generic injection is intended for adults and adolescents weighing at least 35 kg who are at risk of sexually acquired HIV-1. Under an existing licensing arrangement, the medicine is expected to be made available at an annual cost of around $40 per person across 120 eligible countries.

The first supplies are expected to reach countries before the end of 2026, with wider availability planned for 2027.

Lenacapavir was originally developed by US-based Gilead Sciences. Its twice-yearly dosing schedule offers an alternative to daily oral pre-exposure prophylaxis (PrEP), which requires people to take preventive medication regularly to reduce their risk of acquiring HIV.

What is lenacapavir and how does it prevent HIV?

Lenacapavir is a long-acting antiviral medicine belonging to a class of drugs known as HIV-1 capsid inhibitors. It works by targeting the capsid, the protein shell that surrounds the virus’s genetic material.

Unlike several other HIV medicines that target a particular stage of the virus’s life cycle, lenacapavir interferes with multiple stages of the viral replication process. This prevents HIV from multiplying and spreading in the body.

The medicine has been developed for both HIV treatment and prevention, although the formulations and dosing schedules differ depending on its intended use.

For HIV prevention, lenacapavir is administered as an injection twice a year. This long-acting approach is intended to provide sustained protection without requiring users to take a preventive tablet every day.

The World Health Organization (WHO) has also recommended twice-yearly injectable lenacapavir as an HIV prevention option in its guidelines.

The medicine received further scientific recognition when the journal Science named it the 2024 ‘Breakthrough of the Year’, highlighting its potential to change HIV prevention strategies.

Why is the US FDA approval important?

The FDA’s tentative approval is an important regulatory milestone for Dr Reddy’s because it clears a key step towards supplying its generic version in eligible markets under the applicable access arrangements.

The development follows a voluntary licensing agreement granted by Gilead Sciences to Dr Reddy’s in October 2024. The agreement allows the Indian pharmaceutical company to develop and manufacture a generic version of the medicine for specified countries.

In September 2025, Dr Reddy’s entered into an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI), and the Clinton Health Access Initiative (CHAI).

The partnership was intended to support product development, regulatory processes and wider access to the medicine.

The PEPFAR framework is also significant because it supports efforts to expand HIV prevention and treatment services in countries with a substantial burden of the disease.

Tentative approval is not the same as unrestricted approval for sale in the United States. It is a regulatory status that can allow a generic product to be supplied in eligible countries under specific public health arrangements, subject to applicable conditions.

Twice-yearly injection could address daily medication challenges

One of the major challenges in HIV prevention is ensuring that people can consistently follow the recommended medication schedule.

Pre-exposure prophylaxis, commonly known as PrEP, involves using HIV medicines before potential exposure to reduce the risk of infection. Daily oral PrEP is an established prevention option, but taking a tablet every day can be difficult for some people.

Lifestyle, privacy concerns, access to healthcare and the challenge of maintaining a regular medication routine can affect adherence.

A twice-yearly injection could help address some of these barriers by reducing the frequency of medication administration.

The potential advantages include:

  • Fewer doses: People receive two injections annually instead of taking a preventive tablet every day.
  • Convenience: Those who find it difficult to maintain a daily medication routine may prefer a long-acting option.
  • Privacy: Some individuals may find periodic injections more discreet than keeping daily HIV prevention medication at home.
  • Potentially wider access: The planned annual price of around $40 could make the medicine more accessible in eligible low- and middle-income countries.
  • An additional prevention choice: Lenacapavir provides another option for people who may not prefer or be able to use daily oral PrEP.

The medicine’s longer dosing interval could therefore help healthcare programmes reach people who face practical barriers to using existing prevention methods.

HIV testing remains essential before injections

Despite its long-acting nature, lenacapavir requires appropriate medical supervision.

A person’s HIV-negative status must be confirmed before starting the medicine and before every subsequent injection. This is important because lenacapavir is intended to prevent HIV infection and is not a substitute for a complete HIV treatment regimen.

Healthcare providers must follow the recommended testing and monitoring procedures to ensure that the medicine is being used appropriately.

The injection is designed to reduce the risk of sexually acquired HIV-1, but it does not protect against other sexually transmitted infections.

People using lenacapavir should therefore continue to consider other appropriate prevention measures, including condoms and regular sexual health screening.

The medicine should be administered according to the prescribed schedule, with medical professionals advising users on testing, follow-up and any potential side effects.

CHAI highlights the importance of affordable HIV prevention

Dr Neil Buddy Shah, chief executive officer of the Clinton Health Access Initiative, highlighted the challenges associated with daily HIV prevention medication.

“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t 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,” he said.

Shah also pointed out that more than 1,25,000 people in Africa had already started using lenacapavir.

He said the availability of a generic version could help bring the medicine within reach of millions more people.

The proposed annual price of $40 is particularly important for public health programmes in countries where the cost of preventive medication can be a barrier to wider adoption.

However, the final impact will depend on the availability of supplies, national regulatory processes, healthcare infrastructure and the ability of local programmes to provide testing and follow-up services.

Dr Reddy’s says approval reflects manufacturing capabilities

Deepak Sapra, chief executive officer of API and Services at Dr Reddy’s Laboratories, described the development as a significant achievement for the company.

He said developing and manufacturing a complex long-acting injectable at an affordable price required strong scientific and manufacturing capabilities.

“This is a moment of immense pride for all of us at Dr. Reddy’s. Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need,” Sapra said.

He added that the FDA approval brought the company closer to making the twice-yearly HIV prevention option available to people across low- and middle-income countries.

The development also highlights the role Indian pharmaceutical manufacturers can play in expanding access to complex medicines through generic production and international licensing agreements.

Supplies expected before the end of 2026

The first supplies of the generic injection are expected to reach eligible countries before the end of 2026, while broader availability is planned for 2027.

The medicine is expected to be priced at around $40 per person annually across 120 countries covered by the voluntary licence.

For countries with limited healthcare resources, the availability of a lower-cost, long-acting HIV prevention medicine could offer an additional tool in efforts to reduce new infections.

Dr Reddy’s FDA approval represents a significant step in that direction. However, the success of the rollout will depend on how quickly supplies reach eligible markets and how effectively healthcare systems integrate the injections into existing HIV prevention programmes.