FDA Orange Book

Generic for Xyrem

Xyrem contains sodium oxybate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Xyrem is sodium oxybate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Xyrem products in the Orange Book

Xyrem products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, oral	0.5GM/ML	Marketed (Rx)	AA	2	AA

NDA 021196, held by JAZZ PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic sodium oxybate

Approved generic versions of Xyrem
Company	ANDA	TE code	Approved	Strengths
AMNEAL PHARMACEUTICALS LLC	203631	AA (A-rated, therapeutically equivalent)	September 10, 2025	0.5GM/ML
ASCENT PHARMACEUTICALS INC	210523	AA (A-rated, therapeutically equivalent)	November 5, 2025	0.5GM/ML

Xyrem patents

Patents listed for Xyrem
Patent	Expires	Covers	Use code	NDA
10213400	March 15, 2033	Method of use	U-2499	021196
9486426	March 15, 2033	Method of use	U-1532	021196
9050302	March 15, 2033	Method of use	U-1532	021196
8772306	March 15, 2033	Method of use	U-1532	021196
11986446	March 15, 2033	Method of use	U-3324	021196
10864181	March 15, 2033	Method of use	U-1532	021196
11253494	March 15, 2033	Method of use	U-3323	021196
11253494	March 15, 2033	Method of use	U-3324	021196
8772306*PED	September 15, 2033	Method of use	None	021196
9486426*PED	September 15, 2033	Method of use	None	021196
9050302*PED	September 15, 2033	Method of use	None	021196
11253494*PED	September 15, 2033	Method of use	None	021196
10213400*PED	September 15, 2033	Method of use	None	021196
10864181*PED	September 15, 2033	Method of use	None	021196

Xyrem exclusivity

Exclusivity listed for Xyrem
Code	Meaning	Expires	NDA
ODE-231	Orphan drug exclusivity	October 26, 2025	021196
PED	Pediatric exclusivity	April 26, 2026	021196

Xyrem NDC codes

Questions

Is there a generic for Xyrem?

Yes. The generic name for Xyrem is sodium oxybate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Xyrem?

The active ingredient in Xyrem is sodium oxybate, per the FDA Orange Book.

When does the Xyrem patent expire?

The last patent listed for Xyrem in the Orange Book expires September 15, 2033. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.