Rilpivirine manufacturers

About rilpivirine

Rilpivirine manufacturers are led by the originator, Janssen (Johnson & Johnson), which sells Edurant, with rilpivirine also included in combination products from Gilead and ViiV Healthcare. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used for HIV-1. It is available as a daily tablet and, with cabotegravir, as a long-acting injection given every one or two months. Its US compound patent expired in October 2025. Pharmaceutical companies can source rilpivirine tablets and API through out-licensing, supply or technology transfer.

Rilpivirine key facts

Rilpivirine manufacturers and licensing history

Janssen developed rilpivirine as a second-generation NNRTI. The FDA approved Edurant 25 mg tablets on 20 May 2011, and a paediatric formulation, Edurant PED, followed. Gilead combined rilpivirine with emtricitabine and tenofovir in Complera (Eviplera in the EU) and Odefsey. ViiV combined it with dolutegravir in Juluca.

Rilpivirine is also the first NNRTI available as a long-acting injection. With ViiV's cabotegravir, it is given every one or two months, sold as Cabenuva in the US and as Rekambys with Vocabria in the EU.

The main US compound patent for rilpivirine expired in October 2025, but no generic Edurant had been approved as of early 2026. Buyers should confirm API polymorph, GMP status and any remaining formulation patents before choosing a dossier partner.

Rilpivirine dosage forms and dossier types

Rilpivirine is approved as 25 mg tablets, paediatric tablets for oral suspension, fixed-dose combinations and a long-acting injection.

Rilpivirine regulatory and patent status

The FDA approved Edurant on 20 May 2011. Its main US compound patent expired in October 2025, opening the way for generic tablets, subject to any remaining formulation patents. Combination products and the long-acting injection have separate patent protection. Check the FDA Orange Book and national registers before filing.

Rilpivirine mechanism of action and therapeutic use

Rilpivirine binds directly to HIV reverse transcriptase and blocks the conversion of viral RNA into DNA. It is used with other antiretrovirals for HIV-1 treatment, as a once-daily tablet taken with a meal. Long-acting rilpivirine with cabotegravir allows injections every one or two months instead of daily tablets for people with suppressed viral load.

Rilpivirine licensing and sourcing

Rilpivirine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier readiness, patent position and territory availability. Current offers and supplier contacts are listed among the rilpivirine manufacturers on Pipelinepharma.

Frequently asked questions about rilpivirine

Who are the main rilpivirine manufacturers? Janssen is the originator and sells Edurant. Gilead and ViiV Healthcare include rilpivirine in combination products such as Odefsey, Juluca and Cabenuva.

Is there a generic version of rilpivirine? The main US compound patent expired in October 2025, but no generic Edurant had been approved as of early 2026.

What forms and strengths of rilpivirine are available? Rilpivirine is available as 25 mg tablets, 2.5 mg tablets for oral suspension for children, fixed-dose combinations and a long-acting injection.

What is long-acting rilpivirine? Long-acting rilpivirine is an injection given with cabotegravir every one or two months, sold as Cabenuva in the US and Rekambys in the EU.

What is rilpivirine used for? Rilpivirine is used with other antiretrovirals to treat HIV-1 infection.