Dabigatran Etexilate
Overview
Dabigatran Etexilate is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL539697).
API suppliers (7)
Suppliers of Dabigatran Etexilate evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 5 of 7 suppliers.
4 of 7 hold a GMP certificate on record in the EU or UK registers
- Neuland Laboratories LimitedIndia1 active DMF
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- ACEBRIGHT INDIA PHARMA PRIVATE LTDIndia1 active DMF
- ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
- SICHUAN RENAN PHARMACEUTICAL CO LTD GMP on record
- ZAKLADY FARMACEUTYCZNE POLPHARMA SA
- Intas Pharmaceuticals Ltd.India GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (32 approved US products), the latest listed US patent on Dabigatran Etexilate expires 20 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
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