Rifapentine

The prevention and control of drug-resistant tuberculosis is a long-term challenge in the global public health field, and anti-tuberculosis drugs with both high efficacy and low toxicity are the core support for the optimization of clinical regimens. Rifapentine is a semi-synthetic broad-spectrum antibacterial agent of the rifamycin class. It exerts a bactericidal effect by inhibiting the DNA-dependent RNA polymerase of Mycobacterium tuberculosis and blocking the RNA synthesis process of pathogens. Its antibacterial activity is 2-10 times that of rifampicin, and it has a longer half-life, which can significantly reduce the frequency of administration. In addition to being combined with other anti-tuberculosis drugs for the initial and retreatment of various types and stages of tuberculosis, this drug can also be used for the combined treatment of non-tuberculous mycobacterial infections and leprosy, especially suitable for drug-resistant tuberculosis patients who require long-term medication and people who are intolerant to the adverse reactions of rifampicin.

The global anti-tuberculosis drug market has maintained a steady growth trend in recent years, among which rifamycin drugs account for approximately 18%. As a long-acting core variety, rifapentine had a global market size of approximately USD 120 million in 2023, with the Chinese market accounting for more than 60%, and the compound annual growth rate maintained at around 7%. At present, domestic generic drug enterprises occupy the main market share, and the market share of the original research product is less than 5%. As of 2024, 12 enterprises have obtained the production approval for rifapentine preparations, and 7 product specifications have been included in the national centralized volume-based procurement. The average price of the selected products has decreased by 68% compared with that before the procurement, and the clinical accessibility has been greatly improved.

The original research enterprise of rifapentine is Chiesi Farmaceutici S.p.A. of Italy, with the original brand name Rifadin. Its core compound patent expired globally in 2001. The original dosage form is mainly oral capsules, with common specifications of 150mg and 300mg. The relevant product specifications have been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* of China. In terms of the domestic market, as of now, the rifapentine APIs of 11 enterprises have completed registration with the CDE and obtained the A status label, and 13 domestic rifapentine preparation varieties have been approved for marketing, which are consistent with the original research product in quality and efficacy. (Data as of July 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of rifapentine, CATO provides a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process research needs of pharmaceutical enterprises such as registration and declaration, quality research, and batch release, helping relevant enterprises effectively shorten the R&D cycle and improve the efficiency of quality control.