Generic Xyrem Availability

Last updated on Apr 10, 2025.

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]

Is there a generic version of Xyrem available?

An Authorized Generic version of Xyrem has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

sodium oxybate ORAL SOLUTION .5 g/mL
Hikma Pharmaceuticals USA Inc.
NDC Code: 000549628
sodium oxybate ORAL SOLUTION .5 g/mL
Amneal Pharmaceuticals NY LLC
NDC Code: 692382391

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.

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
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 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 SODIUM OXYBATE 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
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 PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
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.
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
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
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:
- October 26, 2025 - INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
- April 26, 2026 - PEDIATRIC EXCLUSIVITY

More about Xyrem (sodium oxybate)

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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

7.6 / 10

108 Reviews

Images

Pill medicine is Xyrem 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate) — Xyrem 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate)