Rilpivirine

As a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), rilpivirine binds non-competitively to HIV-1 reverse transcriptase and inhibits its activity, blocking the viral replication process. Compared with first-generation NNRTIs, it has higher antiviral activity and lower risk of drug resistance mutations. It is clinically indicated mainly for the treatment of adult and adolescent patients aged 12 years and older infected with human immunodeficiency virus type 1 (HIV-1). It is usually used in combination with other antiretroviral drugs, especially suitable for HIV-infected patients with low viral load and poor tolerance to existing treatment regimens, providing a milder medication option for long-term antiviral therapy.

The current global market size of anti-HIV drugs has exceeded 40 billion US dollars, among which NNRTI drugs account for approximately 12% of the market share. Relying on its advantages of low dose and low incidence of adverse reactions, rilpivirine maintains an average annual growth rate of around 8% in the prescription volume among treatment-naive patients. In terms of the domestic market, along with the increase in the demand for long-term management of HIV-infected patients, rilpivirine has been included in the National Medical Insurance Catalogue. Currently, there are fewer than 5 domestic enterprises filing applications for its generic drugs, the competitive landscape is relatively relaxed, and there is still room for further filling the supply gap of its active pharmaceutical ingredient (API).

The original manufacturer of rilpivirine is Janssen Pharmaceuticals under Johnson & Johnson, with the original brand name "Edurant". The core compound patent of rilpivirine expires in the United States in 2027, while the compound patent in China has expired in 2023. The dosage form approved for the original product is oral tablet with a specification of 25mg, which has been included in the Catalogue of Marketed Drugs in China as the reference listed drug (RLD), and is also included in the FDA Reference Listed Drug Catalogue. As of the retrieval time, 3 domestic enterprises in China have obtained the public notification of Grade A status for their rilpivirine APIs through the CDE registration platform, and another 6 enterprises have obtained approval for the marketing of their generic preparations of rilpivirine. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for rilpivirine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the qualitative and quantitative analysis of impurities during the R&D and quality research stages of APIs and preparations, helping enterprises accelerate the progress of R&D and registration.