Xyrem is a brand name of sodium oxybate, approved by the FDA in the following formulation(s):
XYREM (sodium oxybate - solution; oral)
Manufacturer: JAZZ
Approval date: July 17, 2002
Strength(s): 500MG/ML [RLD]
Has a generic version of Xyrem been approved?
No. There is currently no therapeutically equivalent version of Xyrem available.
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: About generic drugs.
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.
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:
- July 4, 2020✓
- July 4, 2020
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:
- July 4, 2020✓
- July 4, 2020
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✓
- June 16, 2024
Sensitive drug distribution system and method
Patent 7,765,106
Issued: July 27, 2010
Inventor(s): Reardan; Dayton T. & Engel; Patti A. & 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✓
- June 16, 2024
Sensitive drug distribution system and method
Patent 7,765,107
Issued: July 27, 2010
Inventor(s): Reardan; Dayton T. & Engel; Patti A. & 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✓
- June 16, 2024
Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Patent 7,851,506
Issued: December 14, 2010
Inventor(s): Cook; Harry & Hamilton; Martha & Danielson; Douglas & Goderstad; Colette & Reardan; Dayton
Assignee(s): Jazz Pharmaceuticals, 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:
- December 22, 2019✓
- December 22, 2019✓
- December 22, 2019
Sensitive drug distribution system and method
Patent 7,895,059
Issued: February 22, 2011
Inventor(s): Reardan; Dayton T. & Engel; Patti A. & Gagne; Bob
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✓
- December 17, 2022
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:
- November 18, 2012 - ORPHAN DRUG EXCLUSIVITY
See also...
- Xyrem Consumer Information (Drugs.com)
- Xyrem Consumer Information (Cerner Multum)
- Xyrem Advanced Consumer Information (Micromedex)
- Xyrem AHFS DI Monographs (ASHP)
- Sodium oxybate Consumer Information (Cerner Multum)
- Sodium oxybate Advanced Consumer Information (Micromedex)
- Sodium Oxybate AHFS DI Monographs (ASHP)
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