Dolutegravir

Overview

Dolutegravir is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1229211).

API suppliers (4)

Suppliers of Dolutegravir backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• Laurus Labs LimitedIndia3 active DMF
• LUPIN MANUFACTURING SOLUTIONS LTD2 active DMF
• Cipla USA, Inc.USA2 active DMF
• Hetero Labs LimitedIndia1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (2 approved US products), the latest listed US patent on Dolutegravir expires 7 Jun 2030. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide

Canonical SMILES

C[C@@H]1CCO[C@@H]2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O

InChIKey

RHWKPHLQXYSBKR-BMIGLBTASA-N