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SODIUM OXYBATE

ANDA

SODIUM OXYBATE | A202090 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
JAZZ PHARMACEUTICALS, INC. et al v. ROXANE LABORATORIES, INC. 2:2016cv00469 1 patentANDA 202090sodium oxybate	D.N.J.	2016-01-27	Terminated 2016-03-29	—
JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC. 2:2010cv06108 5 patentsANDA 202090sodium oxybate	D.N.J.	2010-11-22	Terminated 2017-04-11	—

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

Medicare Part D Spending

CMS annual spending data for Sodium Oxybate (2023)

Total Spending

$49.3M

Total Claims

3,308

Beneficiaries

477

Avg Cost/Unit

$32.32

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -10	View Letter (PDF)
Jan 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5GM/ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 17, 2017

No patent or exclusivity listings for this strength.