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XYREM

NDA

SODIUM OXYBATE | N021196 | JAZZ PHARMACEUTICALS INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayPED (+6 mo)ExclusivityIPRPTAB Challenge

2026

2027

2028

2029

2030

2031

2032

2033

2034

Today

Sep. 15, 2033IPR×3

Sep. 15, 2033IPR

Sep. 15, 2033

Sep. 15, 2033

Sep. 15, 2033

Sep. 15, 2033

Mar. 15, 2033

ODE-231

Apr. 26, 2026

PTAB Proceedings

4 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00546	8772306	IPR	Amneal Pharmaceuticals LLC	Institution Denied	2016-02-02	—
IPR2016-00024	8772306	IPR	Ranbaxy, Inc.	Terminated-Settled	2015-10-07	—
IPR2016-00002	8772306	IPR	Par Pharmaceutical, Inc.	Institution Denied	2015-10-06	—
IPR2016-00738	9050302	IPR	RANBAXY INC	Institution Denied	2016-03-10	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

11 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
JAZZ PHARMACEUTICALS IRELAND LIMITED v. TRIS PHARMA, INC. 2:2026cv01739 7 patentssodium oxybate	D.N.J.	2026-02-20	Active	—
Jazz Pharmaceuticals, Inc. et al v. Avadel CNS Pharmaceuticals, LLC 1:2021cv01594 1 patentsodium oxybate	D. Del.	2021-11-10	Terminated 2025-10-27	—
Jazz Pharmaceuticals, Inc. et al v. Avadel CNS Pharmaceuticals, LLC 1:2021cv01138 1 patentsodium oxybate	D. Del.	2021-08-04	Terminated 2025-10-27	—
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC 1:2021cv00691 5 patentssodium oxybate	D. Del.	2021-05-12	Terminated 2025-10-27	—
JAZZ PHARMACEUTICALS, INC. et al v. MALLINCKRODT PLC et al 2:2018cv00029 10 patentsANDA 210936sodium oxybate	D.N.J.	2018-01-02	Terminated 2018-06-15	—
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. et al v. PAR PHARMACEUTICAL, INC. 2:2014cv06150 1 patentANDA 205403sodium oxybate (gamma hydroxybutyrate, GHB)	D.N.J.	2014-10-02	Terminated 2015-04-21	—
JAZZ PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL, INC. 2:2013cv07884 13 patentsANDA 205403sodium oxybate	D.N.J.	2013-12-27	Terminated 2014-05-05	—
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	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xyrem (2023)

Total Spending

$98.5M

Total Claims

5,560

Beneficiaries

855

Avg Cost/Unit

$37.49

Spending Trend

$255.6M(2019)→$287.1M(2020)→$208.3M(2021)→$156.5M(2022)→$98.5M(2023)

YoY Change:+6.1%

5yr CAGR:+7.8%

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

28 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2025	SUPPL -48	View Letter (PDF)
May 23, 2025	SUPPL -47	View Letter (PDF)
Nov 19, 2024	SUPPL -46	View Letter (PDF)
May 23, 2024	SUPPL -44	View Letter (PDF)
Jan 17, 2024	SUPPL -43	View Letter (PDF)
Apr 5, 2023	SUPPL -42	View Letter (PDF)
Aug 23, 2022	SUPPL -40	View Letter (PDF)
Feb 10, 2022	SUPPL -39	View Letter (PDF)
Dec 14, 2021	SUPPL -38	View Letter (PDF)
Aug 13, 2021	SUPPL -36	View Letter (PDF)
Feb 16, 2021	SUPPL -35	View Letter (PDF)
Sep 29, 2020	SUPPL -32	View Letter (PDF)
Jul 22, 2020	SUPPL -34	View Letter (PDF)
Jul 22, 2020	SUPPL -33	View Letter (PDF)
Sep 12, 2019	SUPPL -31	View Letter (PDF)
Oct 29, 2018	SUPPL -30	View Letter (PDF)
Nov 17, 2017	SUPPL -28	View Letter (PDF)
Jan 30, 2017	SUPPL -27	View Letter (PDF)
Jul 16, 2015	SUPPL -23	View Letter (PDF)
Mar 2, 2015	SUPPL -15	View Letter (PDF)
Apr 14, 2014	SUPPL -19	View Letter (PDF)
Dec 20, 2012	SUPPL -13	View Letter (PDF)
Nov 16, 2006	SUPPL -12	View Letter (PDF)
Jul 3, 2006	SUPPL -9	View Letter (PDF)
Nov 22, 2005	SUPPL -5	View Letter (PDF)
Sep 22, 2005	SUPPL -7	View Letter (PDF)
Nov 25, 2003	SUPPL -1	View Letter (PDF)
Jul 17, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5GM/ML

RLDAA

7 patents2 exclusivities▴

SOLUTION;ORAL | Approved: Jul 17, 2002

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8772306	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
9050302	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
9486426	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
10213400	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
10864181	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
11253494	Mar 15, 2033PED: Sep 15, 2033	PED	—	—	—
11986446	Mar 15, 2033	—	—	—	—

Exclusivities (2)

Code	Date	Status
ODE-231	Oct 26, 2025	Expired
PED	Apr 26, 2026	Expired