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Generic Xywav Availability

Last updated on Sep 8, 2021.

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]

Has a generic version of Xywav been approved?

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.

See also: Generic Drug FAQ.

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
    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
    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
  • Patent 10,675,258

    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
  • Patent 10,864,181

    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
  • Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
    Patent 8,591,922
    Issued: November 26, 2013
    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
  • Sensitive drug distribution system and method
    Patent 8,731,963
    Issued: May 20, 2014
    Assignee(s): Jazz Pharmaceuticals, Inc.

    A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.

    Patent expiration dates:

    • December 17, 2022
      ✓ 
      Patent use: METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
  • Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
    Patent 8,772,306
    Issued: July 8, 2014
    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 PATIENTS WITH IDIOPATHIC HYPERSOMNIA WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
    • 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.
  • Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
    Patent 8,901,173
    Issued: December 2, 2014
    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
    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.
  • Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
    Patent 9,132,107
    Issued: September 15, 2015
    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
    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.

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, 2023 - NEW PRODUCT
    • July 21, 2027 -

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.