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FDA Grants Tentative Approval for Generic Lenacapavir

lite News Desk 2 min read

Dr. Reddy’s Laboratories received tentative FDA approval on November 2, 2026, for the first generic version of injectable lenacapavir for HIV prevention, according to a joint statement from the Clinton Health Access Initiative, Unitaid and Wits RHI. The decision is not an authorization to sell the product commercially in the United States.

Lenacapavir provides long-acting HIV prevention through two injections each year. It is used for pre-exposure prophylaxis, or PrEP, which involves taking preventive medicine before exposure to HIV by people at risk of infection.

According to the partners’ statement, the tentative status permits procurement by the U.S. government during the period when the original product remains protected by patent. The statement distinguishes that procurement route from permission for commercial sales in the U.S. market.

For the 120 low- and middle-income countries within Gilead’s voluntary licensing arrangement, the partnership agreement sets an annual injection price of $40 for each person. Unitaid’s background information on the agreement states that the regimen includes an oral course at the start, costing no more than $17 in addition to the injection price.

The partners expect the first supplies to arrive in countries before 2026 ends and anticipate broader availability during 2027. Those dates describe their projected supply schedule, rather than completed deliveries or a confirmed launch.

Before the FDA decision, Gilead was the only supplier of lenacapavir. Its voluntary licensing agreements included six manufacturers of generic medicines, with Dr. Reddy’s among them.

According to the joint statement, the application submitted by Dr. Reddy’s covered both prevention and treatment of HIV using lenacapavir. The company used the FDA’s 505(b)(2) application route, which the statement says permitted a request for priority review.

The partners also stated that development of the generic received support from Unitaid, Wits RHI and the Clinton Health Access Initiative. Their account identifies funding, technical assistance and regulatory support as the contributions provided to Dr. Reddy’s.

* This article is based on publicly available information at the time of writing.

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