Orange Book product · Brand (NDA)
XYREM
SODIUM OXYBATE
At a glance
Jul 17, 2002
Approved
Brand (NDA)
Application
AA
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 17, 2002
24 yr 3 mo ago
Exclusivity ends · ODE-231
Orphan-drug exclusivity (7 years)
Oct 26, 2025
8 mo ago
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Apr 26, 2026
2 mo ago
Today
Patent 10213400 expires
Listed method-of-use patent (U-2499) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 10864181 expires
Listed method-of-use patent (U-1532) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11253494 expires
Listed method-of-use patent (U-3323) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11253494 expires
Listed method-of-use patent (U-3324) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11986446 expires
Listed method-of-use patent (U-3324) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 8772306 expires
Listed method-of-use patent (U-1532) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9050302 expires
Listed method-of-use patent (U-1532) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9486426 expires
Listed method-of-use patent (U-1532) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 10213400*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Patent 10864181*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Patent 11253494*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Patent 8772306*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Patent 9050302*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Patent 9486426*PED expires
Listed listed patent expiration.
Sep 15, 2033
in 7 yr 4 mo
Pharmaceutical detail
Active ingredient
SODIUM OXYBATE
Strength
0.5GM/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 021196
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- 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 (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10213400 | Mar 15, 2033 | in 6 yr 10 mo | U-2499 |
| 10864181 | Mar 15, 2033 | in 6 yr 10 mo | U-1532 |
| 11253494 | Mar 15, 2033 | in 6 yr 10 mo | U-3323 |
| 11253494 | Mar 15, 2033 | in 6 yr 10 mo | U-3324 |
| 11986446 | Mar 15, 2033 | in 6 yr 10 mo | U-3324 |
| 8772306 | Mar 15, 2033 | in 6 yr 10 mo | U-1532 |
| 9050302 | Mar 15, 2033 | in 6 yr 10 mo | U-1532 |
| 9486426 | Mar 15, 2033 | in 6 yr 10 mo | U-1532 |
| 10213400*PED | Sep 15, 2033 | in 7 yr 4 mo | |
| 10864181*PED | Sep 15, 2033 | in 7 yr 4 mo | |
| 11253494*PED | Sep 15, 2033 | in 7 yr 4 mo | |
| 8772306*PED | Sep 15, 2033 | in 7 yr 4 mo | |
| 9050302*PED | Sep 15, 2033 | in 7 yr 4 mo | |
| 9486426*PED | Sep 15, 2033 | in 7 yr 4 mo |
