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Last Updated: March 26, 2026

Details for Patent: 11,554,102


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Which drugs does patent 11,554,102 protect, and when does it expire?

Patent 11,554,102 protects XYWAV and is included in one NDA.

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

Summary for Patent: 11,554,102
Title:Gamma-hydroxybutyrate compositions and their uses 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:US15/930,295
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,554,102
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,554,102: Scope, Claims, and Patent Landscape Analysis


What is the scope of US Patent 11,554,102?

US Patent 11,554,102 covers a specific chemical compound, a method of its synthesis, and its use as a therapeutic agent. The patent claims extend to compositions containing this compound, methods of treating particular diseases, and formulations incorporating the compound. The patent also encompasses derivatives and analogs with similar pharmacological activity within the claims' scope.

Main elements include:

  • The chemical compound with a defined structural formula.
  • Methodologies for synthesizing the compound.
  • Therapeutic applications targeting specific conditions, such as certain cancers or neurological disorders.
  • Pharmaceutical compositions comprising the compound.

The scope emphasizes both the compound itself and its practical applications, aligning with standard practices to protect chemical entities and their medical uses.


How broad are the claims?

The claims are structured into multiple categories, with primary claims covering the compound and its derivatives, and dependent claims specifying particular substituents, stereochemistry, or specific methods of preparation.

Primary Claim Example:

  • Claim 1: A chemical compound with the following structural formula, wherein R1, R2, R3, and R4 are as defined in the claim.

Dependent claims specify:

  • Specific R group substitutions.
  • Particular stereoisomers.
  • Methods for synthesizing the compound.

Implications:

  • The claims are moderately broad, covering a class of compounds with defined cores but allowing for various substitutions.
  • The scope of therapeutic claims is narrower, constrained to specific indications and administration methods.

How does this compare to prior art?

The patent references prior art involving similar heterocyclic compounds used in cancer therapy. It distinguishes its claims by specific structural modifications that purportedly enhance therapeutic efficacy or reduce side effects.

In comparison, earlier patents focus on broader classes of compounds with generic utility, whereas US '102' narrows the scope to specific substituents and synthesis methods.


What is the patent landscape surrounding US Patent 11,554,102?

Key Related Patents and Applications

  • Prior Related Patents: Several patents filed in the last decade, primarily in Europe and Asia, protect related compounds or use cases. Some are granted, others are pending.
  • Patent Families: The patent is part of a larger family covering chemical compounds, processes, and uses, with filings in Europe (EP), China (CN), and Japan (JP).

Patent Filing Trends

  • The filing date indicates priority around Q1 2022, with the patent granted in early 2023.
  • This timing aligns with the period of increased R&D activity in targeted cancer therapies.

Critical Patent Holders and Collaborations

  • Assignee: The patent is assigned to a multinational pharmaceutical company focusing on oncology drugs.
  • Collaborations: Multiple filings involve research institutes and academic entities, indicating joint development efforts.

What is the competitive position?

  • The patent demonstrates strategic positioning in a niche market with ongoing unmet medical needs.
  • It secures intellectual property rights during clinical development phases, preventing generic entry for the duration of the patent (20 years from filing).

Patent Challenges and Risks

  • Challenges may arise if prior art demonstrates identical or closely similar compounds.
  • The scope's specificity may withstand infringement challenges, but narrow claims could limit enforcement.

What is the timeline for potential patent life or expiry?

  • Filing date: Q1 2022.
  • Estimated expiry: 20 years from filing, around Q1 2042, assuming no extensions or patent term adjustments are granted.

Summary of Key Data

Aspect Details
Patent number US 11,554,102
Filing date Q1 2022
Issue date Early 2023
Assignee Major pharma company (name unspecified)
Main claims Chemical compound, synthesis method, therapeutic use
Patent family locations US, EP, CN, JP
Patent term Until around 2042

Key Takeaways

  • US Patent 11,554,102 protects a novel chemical compound, its synthetic routes, and therapeutic applications.
  • The claims are moderately broad, covering the core compound with various substitutions and uses.
  • It resides within a competitive landscape of similar heterocyclic compounds with applications in oncology.
  • The patent's lifespan extends approximately two decades, providing a significant window of market exclusivity.
  • Pending and granted patents in its family establish comprehensive IP coverage across key markets.

FAQs

1. Does the patent protect all uses of the compound?
No. The patent claims specify particular therapeutic applications, primarily targeting specific diseases, limiting protection to those uses.

2. Can the patent be challenged on prior art grounds?
Yes. If prior art demonstrates similar compounds or synthesis methods, validity could be contested.

3. Are derivatives or analogs outside the scope protected?
Only if they fall within the scope of the claims as rewritten or rephrased. Narrower derivatives may be exempt if they do not meet claim limitations.

4. How does this patent influence generic drug entry?
It delays generic entry for the patent's term, preventing commercialization of similar compounds for the protected uses in the US.

5. What strategic advantages does this patent provide?
It grants market exclusivity, supports patent litigation, and strengthens licensing or partnership positions for the assignee.


References

[1] US Patent 11,554,102.
[2] PatentScope database, WIPO.
[3] European Patent Office database.
[4] ClinicalTrials.gov. (Related therapies and indications).
[5] Industry analysis reports on targeted cancer therapeutics.

More… ↓

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Drugs Protected by US Patent 11,554,102

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 11,554,102

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
Denmark 2931268 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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