Afatinib Dimaleate

Overview

Afatinib Dimaleate is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL2105712).

API suppliers (7)

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

• TAPI NL BVNetherlands1 active DMF
• Shandong Anhong Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• FRESENIUS KABI ONCOLOGY LTDIndia GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (9 approved US products), the latest listed US patent on Afatinib Dimaleate expires 5 Jan 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

bis((Z)-but-2-enedioic acid);(E)-N-[4-(3-chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide

Canonical SMILES

CN(C/C=C/C(=O)NC1=C(C=C2N=CN=C(C2=C1)NC3=CC(=C(C=C3)F)Cl)O[C@@H]4COCC4)C.C(=C\C(=O)O)\C(=O)O.C(=C\C(=O)O)\C(=O)O

InChIKey

USNRYVNRPYXCSP-JUGPPOIOSA-N