Nintedanib

5 API suppliersSmall Molecule

Overview

Nintedanib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL502835).

API suppliers (5)

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

Where these suppliers are
Italy1Taiwan1China1India1Finland1

5 of 5 hold a GMP certificate on record in the EU or UK registers

Patent & exclusivity (US)

Per the FDA Orange Book (14 approved US products), the latest listed US patent on Nintedanib expires 7 Dec 2029 and exclusivity 6 Mar 2027. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylate
Canonical SMILES
CN1CCN(CC1)CC(=O)N(C)C2=CC=C(C=C2)N/C(=C\3/C4=C(C=C(C=C4)C(=O)OC)NC3=O)/C5=CC=CC=C5
InChIKey
XZXHXSATPCNXJR-ZIADKAODSA-N
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