Dabigatran Etexilate

Overview

Dabigatran Etexilate is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL539697).

API suppliers (3)

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

• Intas Pharmaceuticals Ltd.India
• Zakłady Farmaceutyczne Polpharma S.A.Poland
• SICHUAN RENAN PHARMACEUTICAL CO LTD

Patent & exclusivity (US)

Per the FDA Orange Book (32 approved US products), the latest listed US patent on Dabigatran Etexilate expires 19 Jul 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

ethyl 3-[[2-[[4-(N'-hexoxycarbonylcarbamimidoyl)anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate

Canonical SMILES

CCCCCCOC(=O)N=C(C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)N

InChIKey

KSGXQBZTULBEEQ-UHFFFAOYSA-N