Sildenafil

Overview

Sildenafil is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL192).

API suppliers (12)

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

• THE MOLECULEZIndia1 active DMF
• Cadila Pharmaceuticals LimitedIndia1 active DMF GMP on record
• AMOLI ORGANICS PVT LTD1 active DMF
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• PH HEALTH LTD1 active DMF
• RAKS PHARMA PVT LTDIndia1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• MSN Organics Private LimitedIndia1 active DMF
• SMS Pharmaceuticals limitedIndia1 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• SIGNA SA DE CV
• MYLAN LABORATORIES LTD GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (79 approved US products), the latest listed US patent on Sildenafil expires 16 Dec 2033 and exclusivity 31 Jan 2030. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,5-d]pyrimidin-7-one

Canonical SMILES

CCCC1=NN(C2=C1NC(=NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)C)OCC)C

InChIKey

BNRNXUUZRGQAQC-UHFFFAOYSA-N