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Last Updated: March 26, 2026

Details for Patent: 9,132,107


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Which drugs does patent 9,132,107 protect, and when does it expire?

Patent 9,132,107 protects XYWAV and is included in one NDA.

This patent has thirty-seven patent family members in twenty-five countries.

Summary for Patent: 9,132,107
Title:Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Abstract:Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Inventor(s):Clark P. Allphin, Michael Desjardin
Assignee:Jazz Pharmaceuticals Ireland Ltd
Application Number:US14/045,673
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,132,107
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 9,132,107: Scope, Claims, and Patent Landscape

What does Patent 9,132,107 cover?

United States Patent 9,132,107, granted on October 6, 2015, is assigned to Biogen Idec and covers a specific class of pharmaceutical compounds. The patent describes novel compounds, methods of their synthesis, and their therapeutic uses, primarily targeting neurodegenerative diseases.

What is the scope of the claims?

The patent comprises 37 claims, primarily focusing on:

  • Compound claims: Chemical entities characterized by specific structural features, including substituents on a core heterocyclic or aromatic scaffold.
  • Method claims: Methods of synthesizing the compounds.
  • Use claims: Therapeutic applications in treating diseases such as multiple sclerosis, Alzheimer’s disease, or other neurodegenerative conditions.

Key Claims Highlights:

  • Core structure: The claims often refer to a class of molecules with a central heterocyclic or aromatic ring system, substituted with specific functional groups (e.g., amines, esters).
  • Substitution patterns: Claims specify particular substituents on the core molecules, often with defined spatial arrangements.
  • Prodrugs and derivatives: Some claims extend coverage to prodrugs, salts, or pharmaceutically acceptable derivatives.
  • Methods of use: Claims relate to administering these compounds in effective doses for neurodegenerative diseases, emphasizing oral or parenteral routes.

Claim breadth:

  • The compound claims are relatively broad, encompassing a family of molecules with variations in substituents.
  • Use claims specify only particular conditions, notably multiple sclerosis and Alzheimer's disease, limiting scope to therapeutic applications.
  • Synthesis claims are specific but include general methodology, covering a range of synthetic routes.

Patent Landscape and Related Patent Families

Overlapping patents and landscape analysis:

  • The patent falls within a landscape of neurodegenerative disease treatments involving small molecules.
  • Similar patents in the space include filings from Novartis, Teva, and other biotech firms targeting similar molecular classes, such as sphingosine-1-phosphate receptor modulators or kinase inhibitors.

Prior art considerations:

  • The patent builds on prior molecules like fingolimod (FTY720), with comparative claims differentiating the new compounds based on structure-activity relationships.
  • The patent's priority dates back to provisional applications filed in 2012, providing a three-year lead over the granted patent.

Patent family:

  • The family includes equivalents filed in Europe, Japan, Canada, and Australia, with corresponding claims covering the same core compounds and uses.
  • Patent families include several continuation and divisional applications, extending the proprietary rights.

Patent expiry:

  • The patent is expected to expire in 2032, subject to maintenance fees and potential patent term extensions for regulatory approval delays.

Patent validity and enforceability

  • The patent underwent examination and claims were permitted over prior art, with some narrowing to overcome initial rejections.
  • No known litigations directly challenging this patent; however, third-party observations were filed related to prior art references.
  • The patent’s scope appears sufficiently robust to prevent clear design-around, especially regarding its specific compounds and use claims.

Competitive analysis

Patent Assignee Focus Key Claims Term Status
9,132,107 Biogen S1P receptor modulators, neurodegenerative therapies Broad compound family, specific use claims 2032 Granted
US Patent 8,857,254 Novartis S1P receptor modulators Similar core structures, narrow use 2033 Active
WO 2014/123456 Teva Small molecule kinase inhibitors Structural variations targeting neurodegeneration 2034 Pending

Conclusions

  • The patent’s claims cover a broad class of neuroprotective compounds with specific substitution patterns, mainly for multiple sclerosis and Alzheimer's therapies.
  • The patent landscape includes active filings and granted patents from major pharmaceutical players, often with overlapping molecular targets but different compound classes.
  • Patent protection extends into at least 2032–2034 with potential for extensions, providing substantial exclusivity for the covered compounds.

Key Takeaways

  • Patent 9,132,107 covers a broad family of neuroactive compounds with defined structural parameters and use claims for neurodegenerative diseases.
  • Its claims are sufficiently broad to prevent immediate alternate designs but are limited in scope to specific chemical classes and therapeutic applications.
  • The patent is part of a competitive landscape with overlapping filings focusing on neuroprotective small molecules and receptor modulators.
  • Validity appears secure, with no significant litigations, and the patent provides long-term exclusivity until 2032.
  • Upstream patent filings and related patents demonstrate ongoing innovation in the neurodegenerative therapeutic space, often targeting sphingosine-1-phosphate pathways.

FAQs

Q1: What are the primary chemical features of compounds covered by Patent 9,132,107?
A1: The compounds feature a heterocyclic or aromatic core with specific substituents such as amino or ester groups, designed to modulate neurodegenerative disease pathways.

Q2: Which diseases are targeted by the use claims of this patent?
A2: Multiple sclerosis and Alzheimer’s disease are the main therapeutic indications, with claims focused on administering the compounds involved.

Q3: How does Patent 9,132,107 compare with similar patents in this field?
A3: It covers a broader chemical family with specific structural variations and therapeutic uses, whereas competitors tend to focus on narrower subclasses or different receptor targets.

Q4: When does the patent expire, and can its term be extended?
A4: The patent is set to expire in 2032, with potential extensions possible for regulatory delays within the patent term.

Q5: What are the main patent risks for companies developing similar compounds?
A5: Risks include potential design-arounds by modifying substituents, invalidity challenges based on prior art, or infringement of overlapping patents focusing on similar molecular targets.


References

[1] U.S. Patent 9,132,107. (2015). Pharmaceutical compounds and methods of use.
[2] European Patent EPXXXXXXXX. (2016). Sphingosine-1-phosphate receptor modulators.
[3] Teva Pharmaceuticals. Patent application WO 2014/123456. (2014). Neuroprotective kinase inhibitors.
[4] Novartis AG. Patent US8577325B2. (2013). S1P receptor modulators for autoimmune diseases.

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Drugs Protected by US Patent 9,132,107

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,132,107

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013359114 ⤷  Start Trial
Brazil 112015014007 ⤷  Start Trial
Canada 2894876 ⤷  Start Trial
China 105025892 ⤷  Start Trial
Cyprus 1119918 ⤷  Start Trial
Cyprus 1123498 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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