Is There a Generic for Xywav?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Xywav (sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate). The Orange Book shows its last listed patent expires February 22, 2041 and its last listed exclusivity ends August 12, 2028.

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Xywav products in the Orange Book

Xywav products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, oral	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	Marketed (Rx)	None	0	None

NDA 212690, held by JAZZ PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Xywav patents

Patents listed for Xywav
Patent	Expires	Covers	Use code	NDA
10675258	January 11, 2033	Method of use	U-2938	212690
9132107	January 11, 2033	Drug product	None	212690
8901173	January 11, 2033	Drug product	None	212690
10195168	January 11, 2033	Drug product	None	212690
8591922	January 11, 2033	Drug product	None	212690
11554102	January 11, 2033	Drug product	None	212690
8772306	March 15, 2033	Method of use	U-3198	212690
11986446	March 15, 2033	Method of use	U-3017	212690
11986446	March 15, 2033	Method of use	U-3324	212690
9050302	March 15, 2033	Method of use	U-1532	212690
10213400	March 15, 2033	Method of use	U-2499	212690
9486426	March 15, 2033	Method of use	U-1532	212690
8772306	March 15, 2033	Method of use	U-1532	212690
10864181	March 15, 2033	Method of use	U-3017	212690
11253494	March 15, 2033	Method of use	U-3323	212690
11253494	March 15, 2033	Method of use	U-3324	212690
10213400*PED	September 15, 2033	Method of use	None	212690
11253494*PED	September 15, 2033	Method of use	None	212690
9050302*PED	September 15, 2033	Method of use	None	212690
9486426*PED	September 15, 2033	Method of use	None	212690
8772306*PED	September 15, 2033	Method of use	None	212690
10864181*PED	September 15, 2033	Method of use	None	212690
11426373	September 19, 2037	Method of use	U-3432	212690
12138233	February 22, 2041	Method of use	U-4044	212690
12582622	February 22, 2041	Method of use	U-4044	212690

Xywav exclusivity

Exclusivity listed for Xywav
Code	Meaning	Expires	NDA
ODE-361	Orphan drug exclusivity	July 21, 2027	212690
PED	Pediatric exclusivity	January 21, 2028	212690
ODE-369	Orphan drug exclusivity	August 12, 2028	212690

Xywav NDC codes

68727-150

Questions

Is there a generic for Xywav?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Xywav (sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate). The Orange Book shows its last listed patent expires February 22, 2041 and its last listed exclusivity ends August 12, 2028.

What is the generic name for Xywav?

The active ingredient in Xywav is sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate, per the FDA Orange Book.

When does the Xywav patent expire?

The last patent listed for Xywav in the Orange Book expires February 22, 2041. 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.