sodium oxybate · Jazz Pharms · NDA 021196
Xyrem
Earliest generic entry, as listed
15 Sep 2033
Blocked by patent: US 10213400, US 10864181, US 11253494, US 8772306, US 9050302, US 9486426.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10213400 | — | 15 Sep 2033 |
| US 10864181 | — | 15 Sep 2033 |
| US 11253494 | — | 15 Sep 2033 |
| US 8772306 | — | 15 Sep 2033 |
| US 9050302 | — | 15 Sep 2033 |
| US 9486426 | — | 15 Sep 2033 |
| US 10213400 | use U-2499 | 15 Mar 2033 |
| US 10864181 | use U-1532 | 15 Mar 2033 |
| US 11253494 | use U-3324 | 15 Mar 2033 |
| US 11253494 | use U-3323 | 15 Mar 2033 |
| US 11986446 | use U-3324 | 15 Mar 2033 |
| US 8772306 | use U-1532 | 15 Mar 2033 |
| US 9050302 | use U-1532 | 15 Mar 2033 |
| US 9486426 | use U-1532 | 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