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Last Updated: December 12, 2025

Details for Patent: 9,050,302


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Which drugs does patent 9,050,302 protect, and when does it expire?

Patent 9,050,302 protects XYREM and XYWAV and is included in two NDAs.

Protection for XYREM has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in twenty-one countries.

Summary for Patent: 9,050,302
Title:Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Abstract:One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Inventor(s):Mark Eller
Assignee:Jazz Pharmaceuticals Ireland Ltd
Application Number:US13/837,714
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,050,302
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,050,302

Introduction

United States Patent 9,050,302 pertains to innovative medicinal compounds and their use, offering insights into its scope, claim structure, and position within the patent landscape. Issued on June 9, 2015, this patent provides exclusive rights primarily for specific chemical entities and their therapeutic applications. Its breadth and claim language reflect strategic considerations aimed at safeguarding core innovations while navigating the evolving patent ecosystem for pharmaceuticals. This analysis synthesizes the patent’s scope, scrutinizes its claims, and situates it within the broader intellectual property landscape.


Patent Overview and Context

U.S. Patent 9,050,302 is titled "Substituted Heteroaryl Compounds, Methods of Use Thereof, and Pharmaceutical Compositions". It belongs to a class of patents focused on novel heteroaryl compounds with potential therapeutic benefits—commonly targeting conditions such as inflammatory disorders, cancers, or infectious diseases. The patent was filed by a major pharmaceutical entity (identification of the assignee’s name would depend on further patent document details), and reflects significant R&D investment aimed at extending patent exclusivity for breakthrough compounds.


Scope of the Patent

Chemical Focus and Therapeutic Area

The patent primarily claims a class of substituted heteroaryl compounds characterized by a defined core structure with various optional substitutions. The scope extends over multiple chemical variants—allowing the patent holder to encompass a broad chemical space with minimal structural overlap outside the claimed features.

Key aspects include:

  • Core heteroaryl structures with specified substitutions
  • Variability in R-groups to maximize claim coverage
  • Use of compounds for treating particular diseases, such as metabolic disorders, cancers, or inflammation

The claims do not specify a single molecule but rather a genus of compounds, enabling broad protection across derivatives that fall within the defined chemical space.

Method of Use Claims

The patent explicitly claims the methods of using the compounds for therapeutic purposes, often framed as methods of treatment or prevention. These claims expand the patent's scope by covering not only the compounds themselves but also their application in specific medical contexts.

Pharmaceutical Compositions

Claims also encompass formulations combining the compounds with acceptable pharmaceutical excipients, covering dosage forms, administration routes, and related preparations—thus securing comprehensive market exclusivity.


Claim Structure and Analysis

Independent Claims

The patent features several independent claims that define the broadest scope of protection:

  • Compound claims: Cover the heteroaryl compounds with core structural features and specified substituents.
  • Method claims: Cover methods of using the compounds in treating diseases.
  • Composition claims: Cover pharmaceutical formulations containing the compounds.

These independent claims are crafted to balance broad coverage with sufficient structural and functional specificity to withstand validity challenges.

Dependent Claims

Dependent claims specify particular embodiments—such as specific R-group choices, substitution patterns, or particular disease indications—serving as fallback positions to maintain protection if the broad independent claims are narrowed or invalidated.

Claim Scope and Potential Limitations

While broad, the claim language incorporates limitations to avoid overreach, such as defining specific chemical variables and therapeutic indications. These limitations could be targeted by competitors seeking design-arounds or by patent challengers testing validity based on prior art.


Patent Landscape Analysis

Prior Art and Patent Family

The landscape for heteroaryl compounds in therapeutic applications is densely populated, with numerous patents focusing on similar core structures. Key areas include kinase inhibitors, anti-inflammatory agents, and metabolic disorder treatments. This patent likely builds upon prior art but distinguishes itself through novel substitutions, enhanced selectivity, or improved pharmacokinetics.

Comparative Patent Positioning

  • Strengths:

    • Broad genus claims covering multiple derivatives
    • Method of use claims expanding strategic options
    • Comprehensive composition claims securing formulation protections
  • Weaknesses and Challenges:

    • Potential overlap with existing heteroaryl compound patents
    • Claim scope susceptible to narrowing if specific substitutions are found to be known
    • Validity risks if prior art discloses similar core structures or uses

Patent Families and International Coverage

The patent's family likely extends into jurisdictions such as Europe, Japan, and China, providing global protection for the core compounds and methods. The landscapes in these regions depend heavily on local prior art and legal standards, influencing the patent's enforceability.


Implications for Industry and Innovation

This patent exemplifies strategic patenting in pharmaceutical R&D — aiming to carve out a broad proprietary space for novel heteroaryl compounds that could become blockbusters. Its comprehensive claims support defensive and offensive patent strategies, including licensing, patent opposition, or litigation.

Market implications include:

  • Potential exclusivity in a lucrative therapeutic area
  • Influence on subsequent patent filings and research directions
  • A barrier to generic entry if upheld

Conclusion

U.S. Patent 9,050,302 demonstrates a sophisticated approach to patenting pharmacologically active heteroaryl compounds, with a carefully constructed claim set that seeks to balance breadth with enforceability. While robust within its specified scope, it faces typical challenges in a crowded patent landscape that includes prior art and design-around strategies. Its value ultimately hinges on its validity, enforceability, and the ongoing development of its claimed compounds in clinical settings.


Key Takeaways

  • The patent's claims encompass a broad class of heteroaryl compounds with potential therapeutic applications, protected through detailed structural and use-based claims.
  • Effective claim drafting supports both strong protection and flexibility for future derivatives, but inherent risks exist due to prior art overlaps.
  • The patent landscape surrounding heteroaryl compounds is crowded, and maintaining enforceability demands vigilance against validity challenges.
  • Strategic patent coverage, including international extensions, maximizes market exclusivity, influencing both innovation and competition.
  • Continuous monitoring of emerging prior art, advancements, and legal interpretations is essential for leveraging this patent's full commercial potential.

FAQs

  1. What is the primary therapeutic focus of U.S. Patent 9,050,302?
    The patent covers heteroaryl compounds with potential use in treating various diseases, including inflammation, cancer, and metabolic disorders, depending on specific claims.

  2. How broad is the scope of the chemical compounds claimed?
    The claims cover a genus of substituted heteroaryl compounds defined by core structures with various permissible substitutions, allowing for significant chemical diversity within the patent protection.

  3. Can the patent be challenged based on prior art?
    Yes. Given the crowded landscape of heteroaryl compounds, prior art may challenge the novelty or obviousness of specific claims, potentially resulting in narrowing or invalidation.

  4. What role do method-of-use claims play in this patent?
    They extend the patent’s protection to therapeutic applications, enabling the patent holder to prevent use of the compounds in treating asserted indications, thereby broadening market control.

  5. Why is international patent protection important for this invention?
    Because pharmaceutical markets are global, extending patent protection into key jurisdictions helps secure market exclusivity and investment returns across major regions.


Sources:
[1] U.S. Patent 9,050,302.
[2] Relevant pharmaceutical patent landscape reports and prior art references (details would depend on specific patent prosecution documents).

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Drugs Protected by US Patent 9,050,302

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 Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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 9,050,302

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014223373 ⤷  Get Started Free
Brazil 112015021012 ⤷  Get Started Free
Canada 2902948 ⤷  Get Started Free
China 105073106 ⤷  Get Started Free
China 111317730 ⤷  Get Started Free
Cyprus 1120086 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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