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SODIUM OXYBATE

ANDA

SODIUM OXYBATE | A203631 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: XYREM(TE code: AA)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC 2:2013cv05450 2 patentsANDA 203631sodium oxybate	D.N.J.	2013-09-12	Terminated 2013-11-06	—
JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC 2:2013cv00391 7 patentsANDA 203631sodium oxybate	D.N.J.	2013-01-18	Terminated 2018-10-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPSODIUM OXYBATE

DMF 240492010

CURIA MISSOURI INCSODIUM OXYBATE

DMF 275992013

ALKEM LABORATORIES LTDSODIUM OXYBATE

DMF 282892014

CAMBREX CHARLES CITY INCSODIUM OXYBATE

DMF 358702022

VERANOVA LPSODIUM OXYBATE AQUEOUS CONCENTRATE

DMF 365772022

GRANULES INDIA LTDSODIUM OXYBATE

DMF 396962025

CHATTEM CHEMICALS INCSODIUM OXYBATE

DMF 403482025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.5GM/ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 10, 2025

No patent or exclusivity listings for this strength.