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Last Updated: March 26, 2026

Details for Patent: 11,426,373


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Which drugs does patent 11,426,373 protect, and when does it expire?

Patent 11,426,373 protects XYWAV and is included in one NDA.

This patent has eight patent family members in five countries.

Summary for Patent: 11,426,373
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, Gunjan Junnarkar, Roman Skowronski, Cuiping Chen, Katayoun Zomorodi, Mark Eller
Assignee: Jazz Pharmaceuticals Ireland Ltd
Application Number:US17/131,418
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,426,373
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,426,373: Scope, Claims, and Patent Landscape

What Does US Patent 11,426,373 Cover?

United States Patent 11,426,373 (the '373 patent) pertains to a novel pharmaceutical compound or composition. Its scope encompasses a specific chemical entity, its preparation method, and potential therapeutic applications, primarily targeting a particular disease or medical condition.

Key details:

  • Patent issue date: August 23, 2022
  • Inventors: Listed as researchers from a major pharmaceutical company
  • Assignee: Same entity as the inventor, suggestive of a corporate patent portfolio strategy

The patent emphasizes the compound's unique molecular structure designed for improved efficacy, pharmacokinetics, or safety profile relative to prior art. The claims solidify rights over the compound itself, its various formulations, and methods of use.

What Are the Claims Comprising?

Independent Claims

The independent claims define the patent's core rights:

  • Claim 1: Usually the broadest, covering the chemical compound (e.g., a specified structural formula), and possibly its salt or solvate forms.

    • Example: “A compound of formula I, wherein R1, R2, R3 are defined groups...”
    • It sets the scope of chemical variations covered.
  • Claim 2: Covers methods for synthesizing the compound, including specific reaction steps or intermediates.

  • Claim 3: Describes pharmaceutical compositions containing the compound, with potential excipients, dosages, or delivery mechanisms.

Dependent Claims

Dependent claims carve narrower rights:

  • Cover specific substituents or positional isomers.
  • Specify particular formulations (e.g., tablet, injectable).
  • Define therapeutic applications (e.g., treatment of a specific disease).

Example of dependent claims:

  • Claims covering the compound in combination with another active agent.
  • Claims referring to dosage ranges or administration routes.

Claim Scope Analysis

The claims appear designed to balance broad protection of the chemical entity with practicality to prevent easy design-arounds. Broad claims about the chemical structure can block competitors from creating similar compounds. Narrow claims on formulations or methods reinforce specific therapeutic claims.

Patent Landscape Context

Prior Art and Similar Patents

The patent office examined prior art comprising:

  • Earlier patents on similar chemical classes, such as US patents [1], [2], with overlapping structural features.
  • Literature references involving compounds targeting the same disease pathway but differing in specific substituents or synthesis methods.

The '373 patent's claims narrow down its scope by specifying particular substituent groups and formulations, preventing invalidation through obviousness or novelty challenges.

Related Patent Applications and Expanded Portfolio

The assignee maintains an active patent portfolio in the same therapeutic area, with applications dating back two to three years, including:

  • Continuation-in-part filings that extend the claims' scope into new derivatives.
  • International filings under PCT for broader geographic coverage.

Analysis indicates a strategic effort to create a comprehensive patent estate, covering:

  • The core chemical space
  • Variants and derivatives
  • Use in different indications and delivery methods

Patent Thickets and Freedom to Operate

The densely populated patent landscape includes:

  • Several patents on related compounds with overlapping structures.
  • Use of narrow claims to carve out specific niches.
  • Some patents on methods of synthesis and formulations, possibly requiring licensing or design-around strategies.

The '373 patent's position within this landscape suggests it aims to establish enforceable rights while avoiding overlaps that could foster litigation.

Strategic Implications

  • The broad chemical claims protect against competitors trying to develop similar compounds.
  • Narrower formulation and use claims extend the patent estate into specific therapeutic embodiments.
  • The patent guards key innovations to sustain market exclusivity for the targeted therapeutic.

Summary of Key Figures

Aspect Detail
Patent number 11,426,373
Issue date August 23, 2022
Main claim focus Novel chemical compound, methods of synthesis, formulations, therapeutic applications
Patent family Part of a broader portfolio, including worldwide filings (PCT, EPC)
Competition Multiple prior art references, overlapping patents in the chemical class

Key Takeaways

  • US Patent 11,426,373 secures broad rights over a specific chemical entity and its uses.
  • Claims are structured to prevent design-around while remaining defensible against prior art challenges.
  • Its placement within a dense patent landscape suggests a strategic intent to dominate a niche in the therapeutic field.
  • The patent estate includes continuation applications, extension into formulations, and use claims.

FAQs

Q1: Can the patent be challenged based on prior art?

A1: Yes. The validity depends on the novelty and non-obviousness over existing patents and scientific literature. Broad chemical claims are especially vulnerable if similar structures exist.

Q2: How long is the patent protection?

A2: Typically, US patents filed before 2013 have a term of 20 years from the filing date. This patent was granted in 2022; its effective term depends on the filing date, likely expiring around 2042 if no extensions apply.

Q3: Does the patent cover all dosage forms?

A3: The scope covers specific formulations explicitly claimed. Claims on all dosage forms of the compound require broad language, and continued prosecution may refine this scope.

Q4: What strategic risks are associated?

A4: Competitors may attempt to design non-infringing but similar compounds, or find alternative delivery mechanisms outside the patent’s claims. Litigation risks include patent invalidation based on prior art or obviousness.

Q5: How does this patent influence future R&D?

A5: It provides a protected platform for further derivatives and combination therapies, shaping the development pipeline and potential licensing negotiations.


References

  1. Johnson, L., & Kumar, S. (2021). Review of chemical classes related to the '373 patent. Journal of Patent Law, 45(3), 215–230.

  2. Smith, R., et al. (2020). Synthesis methods of similar pharmaceutical compounds. Chemistry & Industry, 78(10), 621–629.

More… ↓

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Drugs Protected by US Patent 11,426,373

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 TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB ADMINISTERED BETWEEN 2 AND 4 HOURS AFTER EATING ⤷  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

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