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Details for Patent: 8,324,275

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Patent 8,324,275 protects XYREM and is included in one NDA. There has been one Paragraph IV challenge on Xyrem.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 8,324,275

Title:Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Abstract: Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gammahydroxybutyrate 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.
Inventor(s): Cook; Harry (Eden Prairie, MN), Hamilton; Martha (St. Paul, MN), Danielson; Douglas (Otsego, MI), Goderstad; Colette (St. Paul, MN), Reardan; Dayton T. (Shorewood, MN)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Application Number:13/446,892
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 28th percentile
Forward Citations: 11th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYes8,324,275► subscribe METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYes8,324,275► subscribe METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
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Non-Orange Book Patents for Patent: 8,324,275

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,952,062Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► subscribe
7,851,506Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► subscribe
6,780,889 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,324,275

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria238783► subscribe
Australia2059000► subscribe
Australia779354► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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