SODIUM OXYBATE | N214755 | AVADEL CNS PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 1 patentsodium oxybate (gamma-hydroxybutyrate); calcium oxybate; magnesium oxybate; potassium oxybate | D. Del. | 2025-04-08 | Terminated 2025-10-27 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 1 patentsodium oxybate (gamma-hydroxybutyrate) / gamma-hydroxybutyric acid salts (calcium, magnesium, potassium, sodium) | D. Del. | 2025-04-01 | Terminated 2025-04-15 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 2 patentsgamma-hydroxybutyrate (sodium oxybate); salts of gamma-hydroxybutyric acid (calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate) | D. Del. | 2025-02-25 | Terminated 2025-10-27 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 2 patentsgamma-hydroxybutyrate (sodium oxybate, calcium oxybate, magnesium oxybate, potassium oxybate) | D. Del. | 2025-02-18 | Terminated 2025-02-27 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 1 patentsodium oxybate (gamma-hydroxybutyrate) | D. Del. | 2025-01-14 | Terminated 2025-10-27 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc. et al 1 patentsodium oxybate, gamma-hydroxybutyrate | D. Del. | 2025-01-07 | Terminated 2025-01-16 | — |
Avadel CNS Pharmaceuticals, LLC et al v. Jazz Pharmaceuticals, Inc., et al. 1 patentsodium oxybate (gamma-hydroxybutyrate); calcium oxybate; magnesium oxybate; potassium oxybate | D. Del. | 2025-01-03 | Terminated 2025-10-27 | — |
Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc. 1 patentsodium oxybate oral solution | D. Del. | 2022-07-15 | Terminated 2025-10-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jazz Pharmaceuticals Inc. FDA-2016-P-2672 · 17 docket documents Jazz Pharmaceuticals Inc. filed this citizen petition under 21 U.S.C. § 355(q) requesting that the FDA refuse to approve any abbreviated new drug applications (ANDAs) for generic sodium oxybate (Xyrem) that do not include labeling and risk evaluation and mitigation strategy (REMS) elements addressin | 505(q) | 2016-09-09 | Granted | Jazz Pharmaceuticals Inc. |
Jazz Pharmaceuticals - Citizen Petition FDA-2012-P-0733 · 3 docket documents Jazz Pharmaceuticals, the NDA holder of XYREM (sodium oxybate) oral solution for treating narcolepsy symptoms, filed this citizen petition on July 10, 2012 requesting that the FDA rescind acceptance of ANDAs referencing Xyrem that lack proposed risk management systems, deny acceptance of future such | 505(q) Stay Request | 2012-07-16 | Denied | — |
Jazz Pharmaceuticals Inc - Citizen Petition FDA-2012-P-0499 · 4 docket documents Jazz Pharmaceuticals, Inc., which markets XYREM (sodium oxybate) oral solution for treating excessive daytime sleepiness and cataplexy in narcolepsy patients, filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA immediately publish bioequivale | 505(q) | 2012-05-28 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10272062 | Jul 21, 2037 | — | — | Yes | — | — |
| 10736866 | Jul 21, 2037 | — | — | Yes | — | — |
| 10952986 | Jul 21, 2037 | — | — | — | — | |
| 10973795 | Jul 21, 2037 | — | — | Yes | — | — |
| 11000498 | Jul 21, 2037 | — | — | Yes | — | |
| 11052061 | Jul 21, 2037 | — | — | Yes | — | — |
| 11065224 | Jul 21, 2037 | — | — | Yes | — | — |
| 11400065 | Jul 21, 2037 | — | — | — | — | |
| 11504347 | Jul 21, 2037 | — | — | Yes | — | — |
| 11583510 | Feb 7, 2042 | — | — | — | — | |
| 11602512 | Jul 21, 2037 | — | — | — | — | |
| 11602513 | Jul 21, 2037 | — | — | — | — | |
| 11766418 | Jul 21, 2037 | — | — | Yes | — | — |
| 11779557 | Mar 16, 2042 | — | — | — | — | |
| 11839597 | Jul 21, 2037 | — | — | Yes | — | — |
| 11896572 | Jul 21, 2037 | — | — | Yes | — | — |
| 11986451 | Jul 21, 2037 | — | — | — | — | |
| 12097175 | Jul 21, 2037 | — | — | Yes | — | — |
| 12097176 | Jul 21, 2037 | — | — | — | — | |
| 12109186 | Jul 21, 2037 | — | — | Yes | — | — |
| 12115142 | Jul 21, 2037 | — | — | Yes | — | — |
| 12115143 | Jul 21, 2037 | — | — | Yes | — | — |
| 12115144 | Jul 21, 2037 | — | — | Yes | — | — |
| 12115145 | Jul 21, 2037 | — | — | Yes | — | — |
| 12128021 | Jul 21, 2037 | — | — | — | — | |
| 12138239 | Jul 21, 2037 | — | — | Yes | — | — |
| 12144793 | Jul 21, 2037 | — | — | Yes | — | — |
| 12303478 | Jul 21, 2037 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| NP | May 1, 2026 | Expired |
| ODE-431 | May 1, 2030 | Active |
| ODE-494 | Oct 16, 2031 | Active |