What is the status of Obeticholic acid on the market and is it available?

The original drug Obeticholic acid has been approved for marketing in Europe and the United States since 2016. Its main indication is the treatment of primary biliary cholangitis (PBC). The drug is supplied in the form of 5mg and 10mg tablets, with 30 tablets per box. It is expensive, and the overseas selling price usually exceeds 20,000 yuan when converted into RMB. As the first approved farnesoid

In mainland China, obeticholic acid has not yet received marketing approval, so it cannot be purchased through formal channels and cannot be included in the medical insurance system. Domestic patients who want to obtain original drugs must rely on overseas platforms or overseas medical channels, but these are expensive and involve certain compliance and safety risks. However, with the promotion of global generic drugs, a variety of obeticholic acid generic drugs have appeared in overseas markets, including Beacon Pharmaceuticals of Bangladesh, Mylan Pharmaceuticals of India, and ASEAN Pharmaceuticals of Laos. These generic drugs are basically the same as the original drugs in terms of ingredients and efficacy, and the price is significantly lower, with the price per box ranging from several hundred to one thousand yuan (may fluctuate due to exchange rates).

Clinically, the performance and safety of generic drugs have received certain empirical support. After using generic drugs, patients' liver function indicators such as serum alkaline phosphatase (ALP) and total bilirubin improved significantly, and long-term treatment was well tolerated. Side effects were mostly mild to moderate itching, mild elevation of blood lipids, or mild gastrointestinal discomfort. The price advantage of generic drugs has significantly improved patient compliance, allowing more patients who cannot afford original drugs to continue to receive treatment, thus delaying disease progression and improving quality of life.

Reference materials:https://en.wikipedia.org/wiki/Obeticholic_acid