Generic Lumryz Availability

Last updated on Dec 12, 2024.

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

LUMRYZ (sodium oxybate - for suspension, extended release;oral)

Manufacturer: AVADEL CNS
Approval date: May 1, 2023
Strength(s): 4.5GM/PACKET ^[RLD], 6GM/PACKET ^[RLD], 7.5GM/PACKET ^[RLD], 9GM/PACKET ^[RLD]

Has a generic version of Lumryz been approved?

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

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

Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 10,272,062
Issued: April 30, 2019
Inventor(s): Mégret Claire & Guillard Hervé & Dubuisson Jean-François
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 10,736,866
Issued: August 11, 2020
Inventor(s): Mégret Claire & Guillard Hervé & Dubuisson Jean-François
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Patent 10,925,844
Issued: February 23, 2021
Inventor(s): Grassot Julien & Grangeon Cendrine & Dubow Jordan
Assignee(s): Flamel Ireland Limited
Oral pharmaceutical compositions of sodium oxybate having improved pharmacokinetic properties when administered less than two hours after eating are provided, and therapeutic uses thereof.
Patent expiration dates:
- February 28, 2040
  ✓
  Drug product
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 10,952,986
Issued: March 23, 2021
Inventor(s): Megret Claire & Guillard Herve & Dubuisson Jean-Francois
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 10,973,795
Issued: April 13, 2021
Inventor(s): Megret Claire & Guillard Herve & Dubuisson Jean-Francois
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 11,000,498
Issued: May 11, 2021
Inventor(s): Megret Claire & Guillard Herve & Dubuisson Jean-Francois & Grassot Julien
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
  ✓
  Drug product
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 11,052,061
Issued: July 6, 2021
Inventor(s): Megret Claire & Guillard Herve & Dubuisson Jean-Francois
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 11,065,224
Issued: July 20, 2021
Inventor(s): Megret Claire & Guillard Herve & Dubuisson Jean-Francois
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 11,400,065
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent 11,504,347
Issued: November 22, 2022
Inventor(s): Grassot Julien & Guillard Hervé & Mégret Claire & Dubuisson Jean-François
Assignee(s): Flamel Ireland Limited
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 11,583,510
Patent expiration dates:
- February 7, 2042
  ✓
  Patent use: TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
Patent 11,602,512
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
Patent 11,602,513
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
Patent 11,766,418
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 11,779,557
Patent expiration dates:
- March 16, 2042
  ✓
  Patent use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE
Patent 11,826,335
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WITH A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
Patent 11,839,597
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 11,896,572
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 11,986,451
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
Patent 12,097,175
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,097,176
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION
Patent 12,109,186
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,115,142
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,115,143
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,115,144
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,115,145
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,128,021
Patent expiration dates:
- July 21, 2037
  ✓
  Patent use: TREATMENT OF A DISORDER IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
Patent 12,138,239
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product
Patent 12,144,793
Patent expiration dates:
- July 21, 2037
  ✓
  Drug product

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:
- May 1, 2026 - NEW PRODUCT
- May 1, 2030 - TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
- October 16, 2031 - TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY

More about Lumryz (sodium oxybate)

Patient resources

Lumryz drug information

Other brands

Xyrem

Professional resources

Other brands

Xyrem

Related treatment guides

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

4 Reviews