The latest import price of obeticholic acid in 2025

Obeticholic acid (Obeticholic acid) is a drug used to treat primary biliary cholangitis (PBC) in adults without cirrhosis or compensated cirrhosis and without evidence of portal hypertension. The drug can be used in combination with ursodeoxycholic acid (UDCA), particularly in patients who do not respond well to UDCA, or as a stand-alone treatment in patients who cannot tolerate UDCA. It is unclear whether the use of obeticholic acid improves patient survival or improves symptoms of PBC.

The mechanism of action of obeticholic acid is by activating the farnesoidX receptor (FXR) in the liver and intestines, which plays an important role in regulating the balance between bile acids, lipids and glucose. Activation of FXR by bile acids helps reduce bile acids produced autonomously by the liver, thereby reducing cholestasis, a key feature of primary biliary cholangitis. In 2016, obeticholic acid received accelerated approval from the U.S. Food and Drug Administration (FDA) under the name Ocaliva. This approval was based on sustained efficacy shown in clinical trials.

Currently, obeticholic acid has not been approved for marketing in China, so it is not eligible for medical insurance policies, and its domestic market price has not yet been determined. In the international market, the common specifications of the original drug of obeticholic acid are 5mg×30 tablets and 10mg×30 tablets. The price of each box may exceed 20,000 yuan, and the specific price is affected by exchange rate fluctuations. Although the original drug is effective, its high price makes it unaffordable for many patients.

It is worth noting that generic drugs of obeticholic acid are available in overseas markets. The ingredients of these generic drugs are similar to the original drugs. The main suppliers include ASEAN Pharmaceuticals in Laos, Beacon Pharmaceuticals in Bangladesh, and Mylan Pharmaceuticals in India. Their prices are relatively affordable, usually between a few hundred to one thousand yuan, and are also affected by exchange rate changes.

Reference materials:https://www.drugs.com/obeticholic-acid.html