Dolutegravir
Overview
Dolutegravir is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1229211).
API suppliers (6)
Suppliers of Dolutegravir evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 4 of 6 suppliers.
2 of 6 hold a GMP certificate on record in the EU or UK registers
- Laurus Labs LimitedIndia3 active DMF GMP on record
- Cipla USA, Inc.USA2 active DMF
- LUPIN MANUFACTURING SOLUTIONS LTD2 active DMF
- SUZHOU RYWAY BIOTECH CO LTD1 active DMF
- MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
- Hetero Labs LimitedIndia1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (2 approved US products), the latest listed US patent on Dolutegravir expires 8 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
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