Generic Xywav Availability

Last updated on Apr 10, 2025.

Xywav is a brand name of calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate, approved by the FDA in the following formulation(s):

XYWAV (calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate - solution;oral)

Manufacturer: JAZZ
Approval date: July 21, 2020
Strength(s): 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML ^[RLD]

Is there a generic version of Xywav available?

No. There is currently no therapeutically equivalent version of Xywav available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xywav. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders
Patent 10,195,168
Issued: February 5, 2019
Inventor(s): Allphin Clark P. & DesJardin Michael
Assignee(s): JAZZ PHARMACEUTICLAS IRELAND LIMITED
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Drug product
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 10,213,400
Issued: February 26, 2019
Inventor(s): Eller Mark
Assignee(s): JAZZ PHARMACEUTICALS IRELAND LIMITED
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS SUFFERING FROM EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY WHO ARE CONCOMITANTLY ADMINISTERED SODIUM OXYBATE AND DIVALPROEX SODIUM
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 10213400*PE
Issued: February 26, 2019
Inventor(s): Eller Mark
Assignee(s): JAZZ PHARMACEUTICALS IRELAND LIMITED
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
Method of using gamma-hydroxybutyrate compositions for the treatment of disorders
Patent 10,675,258
Issued: June 9, 2020
Inventor(s): Allphin Clark P. & DesJardin Michael
Assignee(s): Jazz Pharmaceuticals Ireland Limited
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Patent use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 10,864,181
Issued: December 15, 2020
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 10864181*PE
Issued: December 15, 2020
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 11,253,494
Issued: February 22, 2022
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS WHO ARE CONCOMITANTLY ADMINISTERED A SALT OF GAMMA-HYDROXYBUTYRATE AND DIVALPROEX SODIUM
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 11253494*PE
Issued: February 22, 2022
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent 11,426,373
Issued: August 30, 2022
Inventor(s): Allphin Clark P. & Junnarkar Gunjan & Skowronski Roman & Chen Cuiping & Zomorodi Katayoun & Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- September 19, 2037
  ✓
  Patent use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB ADMINISTERED BETWEEN 2 AND 4 HOURS AFTER EATING
Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders
Patent 11,554,102
Issued: January 17, 2023
Inventor(s): Allphin; Clark P. et al.
Assignee(s): JAZZ PHARMACEUTICALS IRELAND LIMITED (Dublin, IE)
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Drug product
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 11,986,446
Issued: May 21, 2024
Inventor(s): Eller; Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited (Dublin, IE)
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
Methods of treating idiopathic hypersomnia
Patent 12,138,233
Issued: November 12, 2024
Inventor(s): Skobieranda; Franck et al.
Assignee(s): Jazz Pharmaceuticals Ireland Limited (Dublin, IE)
The present disclosure relates to methods of treating idiopathic hypersomnia with oxybate, preferably a mixture of salts of oxybate (a mixed salt oxybate).
Patent expiration dates:
- February 22, 2041
  ✓
  Patent use: TREATMENT OF IDIOPATHIC HYPERSOMNIA WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB
Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent 8,591,922
Issued: November 26, 2013
Inventor(s): Allphin Clark P. & DesJardin Michael
Assignee(s): Jazz Pharmacuticals, Inc.
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Drug product
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 8,772,306
Issued: July 8, 2014
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals, Inc.
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING PATIENTS WITH IDIOPATHIC HYPERSOMNIA WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 8772306*PED
Issued: July 8, 2014
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals, Inc.
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
  ✓
  Pediatric exclusivity
Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent 8,901,173
Issued: December 2, 2014
Inventor(s): Allphin Clark P. & DesJardin Michael
Assignee(s): Jazz Pharmacuticals, Inc.
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Drug product
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 9,050,302
Issued: June 9, 2015
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 9050302*PED
Issued: June 9, 2015
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
  ✓
  Pediatric exclusivity
Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent 9,132,107
Issued: September 15, 2015
Inventor(s): Allphin Clark P. & DesJardin Michael
Assignee(s): Jazz Pharmaceuticals Ireland Limited
Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Patent expiration dates:
- January 11, 2033
  ✓
  Drug product
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 9,486,426
Issued: November 8, 2016
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- March 15, 2033
  ✓
  Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent 9486426*PED
Issued: November 8, 2016
Inventor(s): Eller Mark
Assignee(s): Jazz Pharmaceuticals Ireland Limited
One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Patent expiration dates:
- September 15, 2033
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- July 21, 2027 - INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
- January 21, 2028 - PEDIATRIC EXCLUSIVITY
- August 12, 2028 - THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS

More about Xywav (calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate)

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Xywav drug information

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Moderate abuse potential 3

Approval History Drug history at FDA

User Reviews & Ratings

8.1 / 10

16 Reviews

Images

Pill medicine is Xywav 0.5 g/mL oral solution — Xywav 0.5 g/mL oral solution