Sodium Oxybate Patent Expiration
Sodium Oxybate is Used for treating patients with narcolepsy and reducing excessive daytime sleepiness and cataplexy when administered with specific medications. It was first introduced by Jazz Pharmaceuticals Inc
Sodium Oxybate Patents
Given below is the list of patents protecting Sodium Oxybate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Lumryz | US11779557 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Mar 16, 2042 | Alkermes Inc |
| Lumryz | US11583510 | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal | Feb 07, 2042 | Alkermes Inc |
| Lumryz | US10925844 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state | Feb 28, 2040 | Alkermes Inc |
| Lumryz | US10272062 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US10736866 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US10952986 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US10973795 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11000498 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11052061 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11065224 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11400065 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11504347 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11602512 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11602513 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11766418 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11826335 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11839597 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11896572 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US11986451 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12097175 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12097176 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12109186 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12115142 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12115143 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12115144 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12115145 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12128021 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12138239 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12144793 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12226377 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12303478 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state | Jul 21, 2037 | Alkermes Inc |
| Lumryz | US12728110 | Modified Release Gamma-Hydroxybutyrate Formulations Having Improved Pharmacokinetics | Jul 21, 2037 | Alkermes Inc |
| Xyrem |
US10213400 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem |
US10864181 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem |
US11253494 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem |
US8772306 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem |
US9050302 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem |
US9486426 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Sep 15, 2033 | Jazz Pharms |
| Xyrem | US10213400 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US10864181 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US11253494 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US11986446 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US8772306 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US9050302 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem | US9486426 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters | Mar 15, 2033 | Jazz Pharms |
| Xyrem |
US7668730 (Pediatric) | Sensitive drug distribution system and method |
Dec 16, 2024
(Expired) | Jazz Pharms |
| Xyrem |
US7765106 (Pediatric) | Sensitive drug distribution system and method |
Dec 16, 2024
(Expired) | Jazz Pharms |
| Xyrem |
US7765107 (Pediatric) | Sensitive drug distribution system and method |
Dec 16, 2024
(Expired) | Jazz Pharms |
| Xyrem | US7668730 | Sensitive drug distribution system and method |
Jun 16, 2024
(Expired) | Jazz Pharms |
| Xyrem | US7765106 | Sensitive drug distribution system and method |
Jun 16, 2024
(Expired) | Jazz Pharms |
| Xyrem | US7765107 | Sensitive drug distribution system and method |
Jun 16, 2024
(Expired) | Jazz Pharms |
| Xyrem |
US7895059 (Pediatric) | Sensitive drug distribution system and method |
Jun 17, 2023
(Expired) | Jazz Pharms |
| Xyrem |
US8457988 (Pediatric) | Sensitive drug distribution system and method |
Jun 17, 2023
(Expired) | Jazz Pharms |
| Xyrem |
US8589182 (Pediatric) | Sensitive drug distribution system and method |
Jun 17, 2023
(Expired) | Jazz Pharms |
| Xyrem |
US8731963 (Pediatric) | Sensitive drug distribution system and method |
Jun 17, 2023
(Expired) | Jazz Pharms |
| Xyrem | US7895059 | Sensitive drug distribution system and method |
Dec 17, 2022
(Expired) | Jazz Pharms |
| Xyrem | US8457988 | Sensitive drug distribution system and method |
Dec 17, 2022
(Expired) | Jazz Pharms |
| Xyrem | US8589182 | Sensitive drug distribution system and method |
Dec 17, 2022
(Expired) | Jazz Pharms |
| Xyrem | US8731963 | Sensitive drug distribution system and method |
Dec 17, 2022
(Expired) | Jazz Pharms |
| Xyrem |
US6780889 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jan 04, 2021
(Expired) | Jazz Pharms |
| Xyrem |
US7262219 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jan 04, 2021
(Expired) | Jazz Pharms |
| Xyrem | US6780889 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jul 04, 2020
(Expired) | Jazz Pharms |
| Xyrem | US7262219 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jul 04, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US7851506 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US8263650 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US8324275 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US8859619 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US8952062 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem |
US9539330 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun 22, 2020
(Expired) | Jazz Pharms |
| Xyrem | US7851506 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
| Xyrem | US8263650 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
| Xyrem | US8324275 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
| Xyrem | US8859619 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
| Xyrem | US8952062 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
| Xyrem | US9539330 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec 22, 2019
(Expired) | Jazz Pharms |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Sodium Oxybate's patents.
Latest Legal Activities on Sodium Oxybate's Patents
Given below is the list recent legal activities going on the following patents of Sodium Oxybate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 05 Jan, 2026 | US8731963(Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Dec, 2025 | US8772306(Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Aug, 2025 | US11253494 |
| Expire Patent | 07 Jul, 2025 | US8457988(Litigated) |
| Maintenance Fee Reminder Mailed | 21 Jan, 2025 | US8457988(Litigated) |
| Expire Patent | 14 Oct, 2024 | US8263650(Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 May, 2024 | US10864181 |
| Application ready for PDX access by participating foreign offices | 14 May, 2024 | US7895059(Litigated) |
| Maintenance Fee Reminder Mailed Critical
| 29 Apr, 2024 | US8263650(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Apr, 2024 | US9486426 |
Sodium Oxybate's Family Patents
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Clinical Trials
Recent Clinical Trials on Sodium Oxybate:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks | Leiden University Medical Center | NA |
NOT YET RECRUITING
(Aug 1, 2026)
| PHASE2 |
| A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH | Jazz Pharmaceuticals | NA |
RECRUITING
(Aug 1, 2026)
| PHASE3 |
| Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) | Avadel | NA |
COMPLETED
(May 1, 2026)
| PHASE3 |
| Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor | Kristina Simonyan | NA |
NOT YET RECRUITING
(Apr 1, 2026)
| PHASE1 |