SODIUM OXYBATE | A202090 | HIKMA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
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. 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.
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