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 in its drug Xyrem on Jul 17, 2002. Another drug containing Sodium Oxybate is Lumryz. 3 different companies have introduced drugs containing Sodium Oxybate.


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 US10272062 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US10736866 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US10925844 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Feb 28, 2040 Avadel Cns
Lumryz US10952986 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US10973795 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11000498 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11052061 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11065224 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11400065 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Jul 21, 2037 Avadel Cns
Lumryz US11504347 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11583510 Methods of administering gamma hydroxybutyrate formulations after a high-fat meal Feb 07, 2042 Avadel Cns
Lumryz US11602512 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11602513 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11766418 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Mar 16, 2042 Avadel Cns
Lumryz US11826335 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11839597 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11896572 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Lumryz US11986451 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Jul 21, 2037 Avadel Cns
Xyrem US10213400 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US10213400

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 Jazz Pharms
Xyrem US10864181 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US10864181

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 Jazz Pharms
Xyrem US11253494 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US11253494

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 Jazz Pharms
Xyrem US11986446 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 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 US6780889

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jan 04, 2021

(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 US7262219

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jan 04, 2021

(Expired)

Jazz Pharms
Xyrem US7668730 Sensitive drug distribution system and method Jun 16, 2024

(Expired)

Jazz Pharms
Xyrem US7668730

(Pediatric)

Sensitive drug distribution system and method Dec 16, 2024 Jazz Pharms
Xyrem US7765106 Sensitive drug distribution system and method Jun 16, 2024

(Expired)

Jazz Pharms
Xyrem US7765106

(Pediatric)

Sensitive drug distribution system and method Dec 16, 2024 Jazz Pharms
Xyrem US7765107 Sensitive drug distribution system and method Jun 16, 2024

(Expired)

Jazz Pharms
Xyrem US7765107

(Pediatric)

Sensitive drug distribution system and method Dec 16, 2024 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 US7851506

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jun 22, 2020

(Expired)

Jazz Pharms
Xyrem US7895059 Sensitive drug distribution system and method Dec 17, 2022

(Expired)

Jazz Pharms
Xyrem US7895059

(Pediatric)

Sensitive drug distribution system and method Jun 17, 2023

(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 US8263650

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jun 22, 2020

(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 US8324275

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jun 22, 2020

(Expired)

Jazz Pharms
Xyrem US8457988 Sensitive drug distribution system and method Dec 17, 2022

(Expired)

Jazz Pharms
Xyrem US8457988

(Pediatric)

Sensitive drug distribution system and method Jun 17, 2023

(Expired)

Jazz Pharms
Xyrem US8589182 Sensitive drug distribution system and method Dec 17, 2022

(Expired)

Jazz Pharms
Xyrem US8589182

(Pediatric)

Sensitive drug distribution system and method Jun 17, 2023

(Expired)

Jazz Pharms
Xyrem US8731963 Sensitive drug distribution system and method Dec 17, 2022

(Expired)

Jazz Pharms
Xyrem US8731963

(Pediatric)

Sensitive drug distribution system and method Jun 17, 2023

(Expired)

Jazz Pharms
Xyrem US8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US8772306

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 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 US8859619

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jun 22, 2020

(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 US8952062

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Jun 22, 2020

(Expired)

Jazz Pharms
Xyrem US9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US9050302

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 Jazz Pharms
Xyrem US9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Mar 15, 2033 Jazz Pharms
Xyrem US9486426

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Sep 15, 2033 Jazz Pharms
Xyrem US9539330 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Dec 22, 2019

(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


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.

Given below is the list recent legal activities going on the following patents of Sodium Oxybate.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 29 May, 2024 US10864181
Maintenance Fee Reminder Mailed 29 Apr, 2024 US8263650(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 24 Apr, 2024 US9486426
Expire Patent 27 Mar, 2023 US7895059(Litigated)
Expire Patent 20 Mar, 2023 US8952062(Litigated)
Expire Patent 16 Jan, 2023 US7851506(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 23 Nov, 2022 US9050302(Litigated)
Expire Patent 21 Nov, 2022 US8859619(Litigated)
Maintenance Fee Reminder Mailed 10 Oct, 2022 US7895059(Litigated)
Maintenance Fee Reminder Mailed 03 Oct, 2022 US8952062(Litigated)



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Sodium Oxybate Generics

Only one generic application has been filed for Sodium Oxybate.

Given below is the list of companies who have filed for Sodium Oxybate generic.


1. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Sodium Oxybate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5GM/ML solution Discontinued ORAL N/A Jan 17, 2017