Dr. Reddy’s secures FDA tentative approval for generic lenacapavir, targeting HIV prevention access across 120 countries at US$40 annually.
Written By: Siddhi Bhadekar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Dr. Reddy’s Laboratories has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of long-acting injectable lenacapavir for pre-exposure prophylaxis (PrEP), marking a significant step towards expanding access to HIV prevention. Announced on November 2, 2026, the decision covers prevention of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg (77 pounds).
The approval was granted under the FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme. It positions Dr. Reddy’s to supply the twice-yearly injectable across 120 low- and middle-income countries covered by Gilead Sciences’ voluntary licensing agreement, at an agreed price of US$40 per person annually. Initial supplies are expected to reach countries before the end of 2026, with broader availability anticipated in 2027.
FDA Tentative Approval and Regulatory Significance
The FDA’s tentative approval programme allows qualifying generic antiretroviral products to undergo regulatory assessment while patent or exclusivity protections prevent their commercial marketing in the United States. Products receiving tentative approval can be procured for eligible PEPFAR-supported countries, although the decision does not authorize U.S. commercial sales or automatically grant marketing authorization in individual destination countries.
The regulatory milestone is particularly notable because Dr. Reddy’s secured tentative approval approximately 16 months after the originator product received FDA approval for HIV prevention in June 2025.
According to Unitaid and the Clinton Health Access Initiative (CHAI), a targeted regulatory strategy contributed to this accelerated timeline. Dr. Reddy’s combined lenacapavir’s HIV prevention and treatment indications in a single application using the FDA’s 505(b)(2) pathway, enabling the company to request and secure priority review. Financial, technical and regulatory support from Unitaid, CHAI and the Wits Reproductive Health and HIV Institute (Wits RHI) also supported development and regulatory filing.
Licensing, Development and Affordable Access
Gilead granted Dr. Reddy’s a voluntary licence for lenacapavir in October 2024. In September 2025, the company entered into an agreement with Unitaid, Wits RHI and CHAI to accelerate development, support regulatory progression and establish an affordable access price.
Under the agreement, the generic injection is expected to cost US$40 per person annually across the 120 countries included in Gilead’s licensing arrangement. The price is intended to bring long-acting injectable prevention closer to the cost of existing oral PrEP options.
The rapid development also reflects an effort to reduce the historical delay between innovative HIV medicines and generic availability. CHAI noted that the generic reached tentative approval just 16 months after the originator’s prevention approval, compared with the much longer intervals often associated with access to generic versions of new medicines.
Lenacapavir: Mechanism and Clinical Evidence
Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor developed by Gilead Sciences. It interferes with multiple stages of the viral lifecycle and is administered twice yearly for HIV prevention, offering an alternative to daily oral PrEP.
Its clinical evidence comes from Gilead’s Phase 3 PURPOSE programme. PURPOSE 1 (NCT04994509), conducted among adolescent girls and young women in sub-Saharan Africa, reported no HIV infections in the lenacapavir group during its primary efficacy analysis. PURPOSE 2 (NCT04925752), which included cisgender men and gender-diverse participants, demonstrated 96% efficacy against background HIV incidence and 89% greater efficacy than daily oral TDF/FTC.
These findings established the clinical foundation for the originator product. They should not be interpreted as new efficacy results generated from Dr. Reddy’s generic formulation.
The World Health Organization (WHO) recommended twice-yearly injectable lenacapavir as an additional HIV prevention option in July 2025.
Implementation and Global Access Considerations
The access opportunity is substantial, but tentative FDA approval represents a regulatory milestone rather than completed country-level deployment. WHO prequalification, national regulatory requirements, procurement and delivery readiness will influence the pace of introduction.
More than 125,000 people across 10 early-adopter African countries had already started Gilead’s originator lenacapavir before generic availability, according to the partner announcement. This indicates early demand, although wider implementation will require sufficient supply, trained healthcare providers, community engagement and sustainable funding.
HIV-negative status must be confirmed before initiating lenacapavir and before subsequent injections. Appropriate testing is important because administering the drug to people with undiagnosed HIV infection can increase the risk of antiretroviral resistance.
Clinical and Market Interpretation
Dr. Reddy’s tentative FDA approval represents a meaningful advance in the development and manufacturing of complex long-acting generic injectables. The combination of a 16-month regulatory timeline, an agreed US$40 annual access price and licensing coverage across 120 countries creates a potential pathway for wider access to long-acting HIV prevention.
However, the public health impact will depend on how quickly regulatory approvals translate into procurement and sustained country-level delivery. The next phase will test whether accelerated generic development can be matched by affordable financing, reliable supply and healthcare systems capable of delivering twice-yearly prevention services.
References
Dr. Reddy’s Laboratories Ltd. U.S. FDA grants tentative approval for Dr. Reddy’s twice-yearly injectable lenacapavir, advancing access to HIV prevention across 120 countries outside the US. Press release. Hyderabad, India; November 2, 2026.
U.S. Food and Drug Administration. President’s Emergency Plan for AIDS Relief (PEPFAR).
ClinicalTrials.gov. PURPOSE 1: lenacapavir for HIV pre-exposure prophylaxis. Identifier NCT04994509. https://clinicaltrials.gov/study/NCT04994509
ClinicalTrials.gov. PURPOSE 2: lenacapavir for HIV pre-exposure prophylaxis. Identifier NCT04925752. https://clinicaltrials.gov/study/NCT04925752
About the Writer
Siddhi Rajendra Bhadekar (Linkedin) is an M.Pharm professional with expertise in medical and scientific writing, literature review, publication writing, and evidence synthesis, supported by four peer-reviewed publications.
She brings working knowledge of ICH-GCP, MedDRA, pharmacovigilance, ADR/AE reporting, clinical data management, and regulatory documentation.
With experience across pharmaceutical R&D, Quality Control, and Quality Assurance, she combines scientific research skills with strong attention to accuracy and detail.
Her background in manuscript development, publication planning, and scientific communication enables her to translate complex healthcare information into clear, reliable content.
