Rilpivirine Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Edurant, Complera, Odefsey, Juluca

Category: Active Pharmaceutical Ingredient

Rilpivirine hydrochloride is an NNRTI used in oral HIV tablets and fixed-dose combinations. It is sourced by antiretroviral formulators, CDMOs and R&D teams.

Product Description:

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to HIV-1 reverse transcriptase and blocks viral replication. Oral rilpivirine is approved, with other antiretrovirals, for HIV-1 infection in treatment-naive patients aged 2 and older with a baseline viral load at or below 100,000 copies/mL, and it is also a component of fixed-dose combination tablets used in treatment-naive or virologically suppressed patients (reference brand: Edurant, Complera, Odefsey, Juluca).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 13 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Generics/biosimilars on the market (Jan 2026). European Union: Patent expiry; entry not confirmed (2027).

Handling and quality points

Rilpivirine's cyanovinyl double bond can convert from the active (E)-isomer to the (Z)-isomer under light, so the material should be protected from light and the Z-isomer controlled in the specification. It is practically insoluble in water, so particle size and solid form influence dissolution and should be agreed with the supplier. If your project is a long-acting injectable, note that it needs the free base, not the hydrochloride.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.