Macitentan

CAS 441798-33-0 14 FDA-DMF suppliersSmall Molecule

Overview

Macitentan is an endothelin receptor antagonist used in the treatment of pulmonary arterial hypertension (PAH). It works by preventing the vasoconstriction and proliferation effects of endothelin-1, a potent vasoconstrictor.

API suppliers (5)

Suppliers of Macitentan backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

  • Zhejiang Hisun Pharmaceutical Co., Ltd.China2 active DMF
  • APITORIA PHARMA PRIVATE LTDIndia1 active DMF
  • APITORIA PHARMA PRIVATE LTDIndia1 active DMF
  • TAPI NL BV1 active DMF
  • SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (13 approved US products), the latest listed US patent on Macitentan expires 17 Oct 2029 and exclusivity 27 Aug 2028. Generic API sourcing typically opens up once these lapse.

Therapeutic areas

Pulmonary Arterial HypertensionCardiovascular Diseases

Ready to Accelerate Your
Discovery Workflow?

Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.