Is there a generic for Sodium oxybate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Sodium oxybate, referencing the brand LUMRYZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sodium oxybate?

LUMRYZ (NDA 214755, AVADEL CNS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Sodium oxybate?

The Orange Book lists 42 patents against Sodium oxybate products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Sodium oxybate have FDA marketing exclusivity?

Yes. The Orange Book records 14 marketing-exclusivity periods for Sodium oxybate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Sodium oxybate are approved?

Sodium oxybate is approved in the following dosage forms: for suspension, extended release, solution.

FDA Orange Book · active-ingredient family

Sodium oxybate

Sodium oxybate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LUMRYZ · NDA 214755

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension, extended release, solution

Product	Applicant	Application	TE	Approved
LUMRYZRLD×4	AVADEL CNS	NDA 214755	—	May 01, 2023
XYREMRLD	JAZZ PHARMS	NDA 021196	AA	Jul 17, 2002

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
SODIUM OXYBATE	ASCENT PHARMS INC	ANDA 210523	AA	Nov 05, 2025
SODIUM OXYBATE	AMNEAL	ANDA 203631	AA	Sep 10, 2025
SODIUM OXYBATE	HIKMA	ANDA 202090	—	Jan 17, 2017

Marketing exclusivity (14)

NPNew product exclusivity (3 years)
May 01, 2026
2 mo ago
ODE-431Orphan-drug exclusivity (7 years)
May 01, 2030
in 3 yr 11 mo
ODE-494Orphan-drug exclusivity (7 years)
Oct 16, 2031
in 5 yr 5 mo
NPNew product exclusivity (3 years)
May 01, 2026
2 mo ago
ODE-431Orphan-drug exclusivity (7 years)
May 01, 2030
in 3 yr 11 mo
ODE-494Orphan-drug exclusivity (7 years)
Oct 16, 2031
in 5 yr 5 mo
NPNew product exclusivity (3 years)
May 01, 2026
2 mo ago
ODE-431Orphan-drug exclusivity (7 years)
May 01, 2030
in 3 yr 11 mo
ODE-494Orphan-drug exclusivity (7 years)
Oct 16, 2031
in 5 yr 5 mo
NPNew product exclusivity (3 years)
May 01, 2026
2 mo ago
ODE-431Orphan-drug exclusivity (7 years)
May 01, 2030
in 3 yr 11 mo
ODE-494Orphan-drug exclusivity (7 years)
Oct 16, 2031
in 5 yr 5 mo
ODE-231Orphan-drug exclusivity (7 years)
Oct 26, 2025
8 mo ago
PEDPediatric exclusivity (adds 6 months)
Apr 26, 2026
2 mo ago

Listed patents (42)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10213400	Mar 15, 2033	in 6 yr 10 mo	U-2499
9486426	Mar 15, 2033	in 6 yr 10 mo	U-1532
9050302	Mar 15, 2033	in 6 yr 10 mo	U-1532
8772306	Mar 15, 2033	in 6 yr 10 mo	U-1532
11986446	Mar 15, 2033	in 6 yr 10 mo	U-3324
10864181	Mar 15, 2033	in 6 yr 10 mo	U-1532
11253494	Mar 15, 2033	in 6 yr 10 mo	U-3323
8772306*PED	Sep 15, 2033	in 7 yr 4 mo
9486426*PED	Sep 15, 2033	in 7 yr 4 mo
9050302*PED	Sep 15, 2033	in 7 yr 4 mo
11253494*PED	Sep 15, 2033	in 7 yr 4 mo
10213400*PED	Sep 15, 2033	in 7 yr 4 mo
10864181*PED	Sep 15, 2033	in 7 yr 4 mo
12303478	Jul 21, 2037	in 11 yr 3 mo	U-4189
11602513	Jul 21, 2037	in 11 yr 3 mo	U-3576
11602512	Jul 21, 2037	in 11 yr 3 mo	U-3577
11400065	Jul 21, 2037	in 11 yr 3 mo	U-3579
11000498	Jul 21, 2037	in 11 yr 3 mo	ProductU-3580
12128021	Jul 21, 2037	in 11 yr 3 mo	U-4022
11986451	Jul 21, 2037	in 11 yr 3 mo	U-3934
10952986	Jul 21, 2037	in 11 yr 3 mo	U-3601
12097176	Jul 21, 2037	in 11 yr 3 mo	U-4006
11896572	Jul 21, 2037	in 11 yr 3 mo	Product
10272062	Jul 21, 2037	in 11 yr 3 mo	Product
11504347	Jul 21, 2037	in 11 yr 3 mo	Product
12109186	Jul 21, 2037	in 11 yr 3 mo	Product
11839597	Jul 21, 2037	in 11 yr 3 mo	Product
12097175	Jul 21, 2037	in 11 yr 3 mo	Product
12115144	Jul 21, 2037	in 11 yr 3 mo	Product
12144793	Jul 21, 2037	in 11 yr 3 mo	Product
11052061	Jul 21, 2037	in 11 yr 3 mo	Product
12115143	Jul 21, 2037	in 11 yr 3 mo	Product
12115142	Jul 21, 2037	in 11 yr 3 mo	Product
11065224	Jul 21, 2037	in 11 yr 3 mo	Product
12138239	Jul 21, 2037	in 11 yr 3 mo	Product
10973795	Jul 21, 2037	in 11 yr 3 mo	Product
11766418	Jul 21, 2037	in 11 yr 3 mo	Product
12115145	Jul 21, 2037	in 11 yr 3 mo	Product
10736866	Jul 21, 2037	in 11 yr 3 mo	Product
11826335	Jul 21, 2037	in 11 yr 3 mo	U-3751
11583510	Feb 07, 2042	in 15 yr 10 mo	U-3578
11779557	Mar 16, 2042	in 16 yr	U-3705

Sodium oxybate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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