Is macitentan a domestic drug or an imported drug? Summary of drug source and approval information

Macitentan (Macitentan) has both original research and domestically produced drugs in China. The original drug was developed by Actelion (now a subsidiary of Johnson & Johnson). It has been approved for marketing in China and has been included in the medical insurance catalog. It is mainly used to treat pulmonary arterial hypertension (PAH). The common specifications in China are 10mg*30 tablets. Each box sells for about more than 3,000 yuan. After medical insurance reimbursement, the patient's out-of-pocket expenses can be significantly reduced, providing accessibility guarantee for commonly used clinical drugs. Domestic drugs have also entered the market, usually as a supplement to original drugs, with relatively lower prices, increasing patients’ flexibility in choice.

In terms of drug sources, original macitentan is mainly supplied through imported channels to ensure that the quality and efficacy are consistent with international standards. Domestic macitentan is produced by domestic pharmaceutical companies and has been approved for marketing by the National Medical Products Administration (NMPA). After consistency evaluation, the drug ingredients and bioequivalence are basically consistent with the original drug. When patients choose medications, they can decide to use imported original drugs or domestic drugs based on doctor's advice, medical insurance coverage and financial affordability.

In overseas markets, macitentan has both original and generic drugs on the market. For example, the generic version of macitentan produced by a Lao pharmaceutical factory has the same specification of 10mg*30 tablets, and may be sold for more than 300 yuan per box (the price may fluctuate due to exchange rates). The price of overseas generic drugs is lower, but the ingredients and efficacy are basically the same as the original drugs, providing more accessible options for patients under different economic conditions, and also promoting the diversification of global drug supply.

Generally speaking, macitentan is available in both imported original drugs and domestically produced drugs in China, both of which have been approved and can be used in the clinical treatment of pulmonary arterial hypertension. In terms of price, original drugs are slightly higher but are covered by medical insurance, while domestic drugs and overseas generic drugs are cheaper, providing patients with multi-level choices. In the future, as domestic drug research and development progresses and market competition intensifies, patient selectivity and drug accessibility are expected to further improve.

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Macitentan, domestic drugs, imported drugs, drug source information, approval information, medical insurance, drug prices, generic drug reference materials:https://www.drugs.com/ppa/macitentan.html