Bosentan

Overview

Bosentan is a dual endothelin receptor antagonist that is used in the management of pulmonary arterial hypertension (PAH). It works by blocking the effects of endothelin-1, a substance in the walls of blood vessels that causes them to constrict, therefore improving blood flow and reducing blood pressure.

API suppliers (19)

Suppliers of Bosentan evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• HONOUR LAB LTDIndia1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Amino Chemicals LtdMalta1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• ZACH SYSTEM SAFrance1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• MEGAFINE PHARMA P LTDIndia1 active DMF
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Neuland Laboratories LimitedIndia1 active DMF
• PURE AND CURE HEALTHCARE PRIVATE LTDIndia1 active DMF
• ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORYChina1 active DMF
• Cadila Pharmaceuticals LimitedIndia1 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• JUBILANT BIOSYS LTDIndia1 active DMF
• Cipla USA, Inc.USA1 active DMF
• RAKS PHARMA PVT LTDIndia1 active DMF
• TAI HENG INDUSTRY CO LTD

Patent & exclusivity (US)

Per the FDA Orange Book (13 approved US products), the latest listed US patent on Bosentan expires 9 Jul 2037 and exclusivity 24 Feb 2026. Generic API sourcing typically opens up once these lapse.

Therapeutic areas