sodium oxybate · Jazz Pharms · NDA 021196
Xyrem
Blocked by patent: US 10213400 (pediatric extension), US 10864181 (pediatric extension), US 11253494 (pediatric extension), US 8772306 (pediatric extension), US 9050302 (pediatric extension), US 9486426 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Xyrem, though its earliest generic-entry date is 15 Sep 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 7 unexpired
14 Orange Book listing rows for 7 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10213400 | use U-2499 | 15 Sep 2033 |
| US 10213400 listing row | use U-2499 | 15 Mar 2033 |
| US 10213400 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 10864181 | use U-1532 | 15 Sep 2033 |
| US 10864181 listing row | use U-1532 | 15 Mar 2033 |
| US 10864181 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 11253494 | use U-3323, U-3324 | 15 Sep 2033 |
| US 11253494 listing row | use U-3323 | 15 Mar 2033 |
| US 11253494 listing row | use U-3324 | 15 Mar 2033 |
| US 11253494 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 8772306 | use U-1532 | 15 Sep 2033 |
| US 8772306 listing row | use U-1532 | 15 Mar 2033 |
| US 8772306 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 9050302 | use U-1532 | 15 Sep 2033 |
| US 9050302 listing row | use U-1532 | 15 Mar 2033 |
| US 9050302 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 9486426 | use U-1532 | 15 Sep 2033 |
| US 9486426 listing row | use U-1532 | 15 Mar 2033 |
| US 9486426 listing row | pediatric extension · sets the listed date | 15 Sep 2033 |
| US 11986446 | use U-3324 | 15 Mar 2033 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 021196-0015 Nov 2025
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021196 · 001 · RLD | solution, oral | 0.5GM/ML | 15 Sep 2033 |
Expired or delisted (2)
- PED · 26 Apr 2026
- ODE-231 · 26 Oct 2025