SODIUM OXYBATE | N021196 | JAZZ PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-00546 | 8772306 | IPR | Amneal Pharmaceuticals LLC | Institution Denied | 2016-02-02 | — |
| IPR2016-00024 | 8772306 | IPR | Ranbaxy, Inc. | Terminated-Settled | 2015-10-07 | — |
| IPR2016-00002 | 8772306 | IPR | Par Pharmaceutical, Inc. | Institution Denied | 2015-10-06 | — |
| IPR2016-00738 | 9050302 | IPR | RANBAXY INC | Institution Denied | 2016-03-10 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2026-02-20 | Active | — | |
Jazz Pharmaceuticals, Inc. et al v. Avadel CNS Pharmaceuticals, LLC 1 patentsodium oxybate | D. Del. | 2021-11-10 | Terminated 2025-10-27 | — |
Jazz Pharmaceuticals, Inc. et al v. Avadel CNS Pharmaceuticals, LLC 1 patentsodium oxybate | D. Del. | 2021-08-04 | Terminated 2025-10-27 | — |
| D. Del. | 2021-05-12 | Terminated 2025-10-27 | — | |
JAZZ PHARMACEUTICALS, INC. et al v. MALLINCKRODT PLC et al 10 patentsANDA 210936sodium oxybate | D.N.J. | 2018-01-02 | Terminated 2018-06-15 | — |
JAZZ PHARMACEUTICALS, INC. et al v. ROXANE LABORATORIES, INC. 1 patentANDA 202090sodium oxybate | D.N.J. | 2016-01-27 | Terminated 2016-03-29 | — |
JAZZ PHARMACEUTICALS, INC. et al v. PAR PHARMACEUTICAL, INC. 1 patentANDA 205403sodium oxybate (gamma hydroxybutyrate, GHB) | D.N.J. | 2014-10-02 | Terminated 2015-04-21 | — |
JAZZ PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL, INC. 13 patentsANDA 205403sodium oxybate | D.N.J. | 2013-12-27 | Terminated 2014-05-05 | — |
JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC 2 patentsANDA 203631sodium oxybate | D.N.J. | 2013-09-12 | Terminated 2013-11-06 | — |
JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC 7 patentsANDA 203631sodium oxybate | D.N.J. | 2013-01-18 | Terminated 2018-10-15 | — |
JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC. 5 patentsANDA 202090sodium oxybate | D.N.J. | 2010-11-22 | Terminated 2017-04-11 | — |
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 |
|---|---|---|---|---|---|---|
| 8772306 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 9050302 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 9486426 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 10213400 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 10864181 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 11253494 | Mar 15, 2033PED: Sep 15, 2033 | PED | — | — | — | |
| 11986446 | Mar 15, 2033 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| ODE-231 | Oct 26, 2025 | Expired |
| PED | Apr 26, 2026 | Expired |