Sodium Oxybate
Overview
Sodium Oxybate is the sodium salt of gamma-hydroxybutyric acid (GHB), used therapeutically for the treatment of narcolepsy with cataplexy and excessive daytime sleepiness. It acts as a central nervous system depressant modulating GABA receptors in the brain.
API suppliers (6)
Suppliers of Sodium Oxybate 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 5 of 6 suppliers.
2 of 6 hold a GMP certificate on record in the EU or UK registers
- VERANOVA LPUnited Kingdom1 active DMF
- CURIA MISSOURI INC1 active DMF
- Alkem Laboratories LimitedIndia1 active DMF GMP on record
- CAMBREX CHARLES CITY INCUnited States1 active DMF
- Granules India LimitedIndia1 active DMF GMP on record
- CHATTEM CHEMICALS INCUnited States1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (7 approved US products), the latest listed US patent on Sodium Oxybate expires 16 Mar 2042 and exclusivity 16 Oct 2031. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- 4-hydroxybutanoate
- Canonical SMILES
- C(CC(=O)[O-])CO
- InChIKey
- SJZRECIVHVDYJC-UHFFFAOYSA-M
Therapeutic areas
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