Azelastine

CAS 58581-89-8 9 FDA-DMF suppliersSmall Molecule

Overview

Azelastine is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL639).

API suppliers (17)

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

  • Gedeon RichterHungary1 active DMF
  • Ono Pharmaceutical Co., Ltd.Japan1 active DMF
  • Gedeon RichterHungary1 active DMF
  • MSN Laboratories Private LimitedIndia1 active DMF
  • Ono Pharmaceutical Co., Ltd.Japan1 active DMF
  • Gedeon RichterHungary1 active DMF
  • MSN Laboratories Private LimitedIndia1 active DMF
  • Ono Pharmaceutical Co., Ltd.Japan1 active DMF
  • Gedeon RichterHungary1 active DMF
  • Gedeon RichterHungary1 active DMF
  • URQUIMA SA1 active DMF
  • Ono Pharmaceutical Co., Ltd.Japan1 active DMF
  • URQUIMA SA1 active DMF
  • MSN Laboratories Private LimitedIndia1 active DMF
  • VIATRIS GMBH AND CO KG
  • Jiangsu Hengrui Medicine Co., Ltd.China
  • Cipla USA, Inc.USA

Patent & exclusivity (US)

Per the FDA Orange Book (16 approved US products), the latest listed US patent on Azelastine expires 3 Jun 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one
Canonical SMILES
CN1CCCC(CC1)N2C(=O)C3=CC=CC=C3C(=N2)CC4=CC=C(C=C4)Cl
InChIKey
MBUVEWMHONZEQD-UHFFFAOYSA-N

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