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Generic Xyrem Availability

Last updated on Sep 8, 2021.

Xyrem is a brand name of sodium oxybate, approved by the FDA in the following formulation(s):

XYREM (sodium oxybate - solution;oral)

  • Manufacturer: JAZZ PHARMS
    Approval date: July 17, 2002
    Strength(s): 0.5GM/ML [RLD]

Has a generic version of Xyrem been approved?

A generic version of Xyrem was approved January 17, 2017 but it has since been discontinued. There is currently no therapeutically equivalent version of Xyrem available in the United States.

sodium oxybate - solution;oral

  • Manufacturer: HIKMA PHARMACEUTICALS USA INC
    Approval date: January 17, 2017
    Strength(s): 0.5GM/ML
    Marketing Status: Discontinued

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xyrem. 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.

  • 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 10,864,181

    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.
  • Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
    Patent 6,780,889
    Issued: August 24, 2004
    Inventor(s): Harry; Cook & Martha; Hamilton & Douglas; Danielson & Colette; Goderstad & Dayton; Reardan
    Assignee(s): Orphan Medical, Inc.

    Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.

    Patent expiration dates:

    • January 4, 2021
      ✓ 
      Pediatric exclusivity
  • Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
    Patent 7,262,219
    Issued: August 28, 2007
    Inventor(s): Cook; Harry & Hamilton; Martha & Danielson; Douglas & Goderstad; Colette & Reardan; Dayton
    Assignee(s): Orphan Medical, Inc.

    Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.

    Patent expiration dates:

    • January 4, 2021
      ✓ 
      Pediatric exclusivity
  • Sensitive drug distribution system and method
    Patent 7,668,730
    Issued: February 23, 2010
    Inventor(s): Reardan; Dayton T. & Engle; Patti & Gagne; Bob
    Assignee(s): JPI Commercial, LLC.

    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:

    • June 16, 2024
      ✓ 
      Patent use: METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
      ✓ 
      Sponsor has requested patent be delisted
    • December 16, 2024
      ✓ 
      Pediatric exclusivity
  • 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
    • June 17, 2023
      ✓ 
      Pediatric exclusivity
  • 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 EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
    • September 15, 2033
      ✓ 
      Pediatric exclusivity
  • 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.
    • September 15, 2033
      ✓ 
      Pediatric exclusivity
  • 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.
    • 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:

    • October 26, 2021 - NEW PATIENT POPULATION
    • April 26, 2022 - PEDIATRIC EXCLUSIVITY
    • October 26, 2025 -
    • April 26, 2026 - PEDIATRIC EXCLUSIVITY

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.