Darunavir

Overview

Darunavir is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1323).

API suppliers (7)

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

• Cipla USA, Inc.USA3 active DMF
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• RAKS PHARMA PVT LTDIndia1 active DMF
• INNOVARE LABS PRIVATE LTDIndia1 active DMF
• Laurus Labs LimitedIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Zhejiang Jiuzhou Pharmaceutical Co., Ltd.China GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (28 approved US products), the latest listed US patent on Darunavir expires 26 Jun 2027. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

[(3aS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate

Canonical SMILES

CC(C)CN(C[C@H]([C@H](CC1=CC=CC=C1)NC(=O)O[C@H]2CO[C@@H]3[C@H]2CCO3)O)S(=O)(=O)C4=CC=C(C=C4)N

InChIKey

CJBJHOAVZSMMDJ-HEXNFIEUSA-N