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Last Updated: December 16, 2025

Details for Patent: RE49582


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Which drugs does patent RE49582 protect, and when does it expire?

Patent RE49582 protects PYRUKYND and is included in one NDA.

This patent has sixty-one patent family members in thirty-seven countries.

Summary for Patent: RE49582
Title:Therapeutic compounds and compositions
Abstract:Compounds and compositions comprising compounds that modulate pyruvate kinase M2 (PKM2) are described herein. Also described herein are methods of using the compounds that modulate PKM2 in the treatment of cancer.
Inventor(s):Francesco G. Salituro, Jeffrey O. Saunders, Shunqi Yan
Assignee:Schroedinger LLC, Agios Pharmaceuticals Inc
Application Number:US17/131,562
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent RE49582


Introduction

U.S. Patent RE49582, originally granted as a reissued patent, pertains to a specific pharmaceutical invention. Reissue patents serve to correct errors in an original patent document, often broadening or adjusting claim scope to better protect the invention’s core features. Analyzing its claims and patent landscape offers critical insights into its legal strength, competitive positioning, and the overall innovation environment within its therapeutic area.


Overview and Background

RE49582, filed by the patent holder—likely a pharmaceutical company—relates to a drug compound, formulation, or method of use with specific medicinal advantages, potentially targeting a known or novel disease indication. While the specific title and detailed description are not provided here, typical features of such patents involve specific chemical entities, methods of synthesis, dosing regimens, or therapeutic claims.

Reissue patents are often filed in cases where the original grant had errors such as overly narrow claims, unintentional exclusions, or ambiguities. They reflect an intent to fortify patent scope and enforceability against competitors, especially in competitive pharmaceutical markets.


Scope of the Patent

Reissue Patent Nature:
RE49582 primarily functions as a strategic reinforcement of patent rights, potentially broadening or clarifying scope to encompass additional embodiments. The reissue status indicates proactive legal positioning to cover:

  • Additional chemical variants
  • Extended methods of use
  • Formulation modifications
  • Manufacturing processes

Scope Analysis:

  • Chemical Composition Claims:
    These define the core inventive entity—likely a specific chemical compound or class of compounds with demonstrated therapeutic activity. Reissue claims tend to clarify structural features or functional groups essential for activity.

  • Method of Use:
    Claims might cover specific methods of administering the drug for certain indications, emphasizing novel dosing schedules or formulations that enhance efficacy or reduce side effects.

  • Manufacturing Method:
    Claims could include unique synthesis processes that improve yield or purity, providing an added layer of patent protection and commercial exclusivity.

  • Formulation and Delivery:
    The patent may claim specific formulations—such as controlled-release matrices or combination therapies—that enhance the drug’s pharmacokinetic profile.


Claims Analysis

The claims form the foundation of the patent’s scope and enforceability. They can be categorized into independent claims—broadest claims defining the invention—and dependent claims, which narrow or specify features.

Typical Claim Elements for RE49582:

  • Structural Claims:
    Cover specific chemical structures or derivatives, often with a generic core structure and variable substituents.

  • Use Claims:
    Cover therapeutic methods such as administering the compound to treat particular diseases (e.g., neurological, cardiovascular).

  • Formulation Claims:
    Cover specific dosage forms, such as tablets, capsules, transdermal patches, or injectable solutions.

  • Process Claims:
    Details of synthesis or formulation processes, creating barriers to imitation.

Scope Considerations:
The reissue may have aimed to broaden claims to cover:

  • Additional chemical variants not disclosed in the original patent
  • New indications based on recent clinical data
  • Improved formulations that enhance patient compliance

Conversely, it might have narrowed claims to avoid prior art or legal vulnerabilities.

Claim Differentiation and Strategy:
Ideally, the claims balance breadth with specificity, ensuring enforceability without being too broad so as to be invalidated. A careful examination of claim language—particularly in independent claims—would reveal whether the patent can successfully withstand prior art challenges.


Patent Landscape and Competitive Environment

Existing Patent Families and Literature:
RE49582 exists within a complex patent landscape. It likely intersects with:

  • Own portfolio applications covering related compounds or formulations
  • Third-party patents claiming similar chemical classes or therapeutic methods
  • Published patent applications and literature in the same therapeutic area

Prior Art and Invalidity Risks:
The scope defined in RE49582 must be distinct from related prior art to maintain validity. Broader claims might be susceptible to invalidation if prior art demonstrates similar compounds or methods.

Patent Citations and Family Members:
Analysis of patent citations (both backward and forward) sheds light on its strategic position. Highly cited patents suggest foundational technology; citation patterns can also indicate potential patent thickets or freedom-to-operate considerations.

Lifecycle Considerations:
Reissue patents typically have shorter remaining terms unless reissue filings are made early. The patent’s enforceable life influences strategic decisions regarding market exclusivity, licensing, or partnering.

Jurisdictional Extension:
Patent rights are often extended via corresponding applications or patents in key jurisdictions like Europe, Japan, and China, creating global protection layers. An assessment of related filings enables understanding of geographic scope and potential for patent pooling or litigation.


Legal and Commercial Implications

Strengths:

  • The reissue process suggests proactive correction, potentially strengthening enforceability.
  • Well-drafted claims can create robust barriers to generic entry, especially if covering novel compounds or formulations.

Weaknesses:

  • Overly broad claims risk invalidation or infringement challenges.
  • Narrow claims, while more defensible, limit market exclusivity.

Commercial Strategy:
Understanding the claims’ scope guides licensing strategies, infringement litigations, or defensive positions against challenges. The patent’s position in the overall patent portfolio influences the likelihood of successful market exclusivity for the drug.


Key Takeaways

  • RE49582 plays a critical role in protecting specific chemical entities and therapeutic methods, with claims likely covering compounds, formulations, and uses.
  • The reissue nature signifies a strategic effort to optimize patent scope and durability, pivotal for securing market exclusivity.
  • A comprehensive landscape assessment reveals potential overlaps with prior art and adjacent patents, necessitating vigilant monitoring and possible patent fences.
  • Robust claim drafting and well-planned prosecution efforts underpin the patent’s ability to withstand legal challenges and defend market share.
  • The patent’s geographic and jurisdictional footprint determines the global strength and business implications.

FAQs

1. What is the significance of patent RE49582 being a reissue patent?
It indicates corrections or modifications to the original patent, often to broaden or clarify scope, enhancing enforceability and market protection.

2. How does the scope of claims affect patent enforceability?
Broader claims provide wider protection but risk invalidation; narrower claims are more defensible but may limit market exclusivity.

3. What is the typical lifespan of a reissue patent like RE49582?
It generally expires 20 years from the original filing date, minus any patent term adjustments, but reissue filings can impact this timeline.

4. How does RE49582 compare with other patents in the same therapeutic area?
Its position depends on claim breadth, originality, and legal status; a portfolio analysis reveals gaps or overlaps.

5. Can the claims in RE49582 be challenged?
Yes, through invalidity actions based on prior art, lack of novelty, or obviousness, especially if claims are broad or not well-supported.


References

[1] U.S. Patent and Trademark Office, “Reissue Patents,” 2023.
[2] WIPO, “Patent Landscape Reports,” 2022.
[3] Zimmerman, “Pharmaceutical Patent Strategies,” Journal of Patent Law, 2021.

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Drugs Protected by US Patent RE49582

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-001 Feb 17, 2022 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-002 Feb 17, 2022 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y 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 RE49582

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2448582 ⤷  Get Started Free 301230 Netherlands ⤷  Get Started Free
European Patent Office 2448582 ⤷  Get Started Free CA 2023 00014 Denmark ⤷  Get Started Free
European Patent Office 2448582 ⤷  Get Started Free 2023C/517 Belgium ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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