Donepezil

Overview

Donepezil is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL502).

API suppliers (23)

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

• Zydus Lifesciences LimitedIndia2 active DMF GMP on record
• Hetero Drugs LimitedIndia2 active DMF GMP on record
• JUBILANT BIOSYS LTDIndia1 active DMF
• USV PRIVATE LTDIndia1 active DMF GMP on record
• SYNTHIMED LABS PRIVATE LIMITEDIndia1 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Torrent PharmaceuticalsIndia1 active DMF GMP on record
• Neuland Laboratories LimitedIndia1 active DMF
• MEGAFINE PHARMA P LTDIndia1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Cipla USA, Inc.USA1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Zhejiang Hisun Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• VASUDHA PHARMA CHEM LTDIndia1 active DMF
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record
• Apotex Pharmachem India Pvt. Ltd.India
• HIKAL LTDPakistan
• PERRIGO API LTD
• Lupin LimitedIndia GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (42 approved US products), the latest listed US patent on Donepezil expires 4 Oct 2026. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one

Canonical SMILES

COC1=C(C=C2C(=C1)CC(C2=O)CC3CCN(CC3)CC4=CC=CC=C4)OC

InChIKey

ADEBPBSSDYVVLD-UHFFFAOYSA-N