Nevirapine

In the combination regimens for AIDS antiviral therapy, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are one of the indispensable core components. As a classic representative of this class of drugs, nevirapine binds non-competitively to the allosteric site of HIV reverse transcriptase, blocking the process of reverse transcription of viral RNA into DNA, thereby inhibiting viral replication. In clinical practice, it is often used in combination with other antiretroviral drugs to treat adult and pediatric patients with HIV type 1 infection. It is particularly widely used in the prevention of mother-to-child transmission regimens in resource-limited regions, which can effectively reduce the risk of mother-to-child transmission of HIV, and provides a cost-effective medication option for AIDS prevention and control.

At present, the global nevirapine market size is approximately USD 180 million. Driven by the continuous release of AIDS prevention and treatment demand in low- and middle-income countries, the compound annual growth rate in the past three years has maintained at around 2.3%. In terms of the domestic market, nevirapine has been included in the National Medical Insurance Catalog and the National Essential Medicine List, and the annual sales at the terminal of public medical institutions have been stable at more than RMB 80 million. The competition landscape is dominated by generic drugs, with the original research product accounting for less than 10% of the market. Domestic API manufacturers are concentrated in Jiangsu, Guangdong and other regions, with sufficient overall supply and significant cost advantages.

The original research enterprise of nevirapine is Boehringer Ingelheim, and the original research trade name is "Viramune". The expiration date of its core compound patent in the United States was 2011, and the Chinese compound patent also expired in 2011. The main dosage forms approved for the original research product include tablets (200mg) and oral suspension (10mg/ml). The original research tablets have been included in the Reference Listed Drug Catalog issued by China NMPA, and are also included in the FDA Orange Book Reference Listed Drug List. As of now, there are 11 valid registration numbers of nevirapine on the API registration platform of China CDE, among which 7 are in the status of "A" (approved for use in marketed preparations). More than 15 domestic enterprises have been approved to produce nevirapine oral preparations, with a mature supply system. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of nevirapine impurity reference standards, covering the full spectrum of requirements such as production process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.