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Last Updated: December 12, 2025

Details for Patent: 11,299,500


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Which drugs does patent 11,299,500 protect, and when does it expire?

Patent 11,299,500 protects LORBRENA and is included in one NDA.

This patent has twenty-six patent family members in twenty-two countries.

Summary for Patent: 11,299,500
Title:Crystalline form of lorlatinib free base hydrate
Abstract:This invention relates to a crystalline form of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclo-tetradecine-3-carbonitrile (lorlatinib) free base hydrate (Form 24). This invention also relates to pharmaceutical compositions comprising Form 24, and to methods of using Form 24 and such compositions in the treatment of abnormal cell growth, such as cancer, in a mammal.
Inventor(s):Paul Bowles, Peter Robert Rose
Assignee: Pfizer Corp SRL
Application Number:US16/650,505
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,299,500

Introduction

U.S. Patent 11,299,500, granted to the assignee on May 10, 2022, represents a significant intellectual property asset within the pharmaceutical landscape. This patent covers novel methods, compositions, or formulations with the potential to influence therapeutic strategies and market competitiveness. An in-depth assessment of its scope, claims, and broader patent landscape is crucial for stakeholders including R&D entities, legal teams, investors, and competitors.

This report presents a comprehensive overview of U.S. Patent 11,299,500, focusing on its legal scope, claim structure, technological territory, and landscape positioning.


Scope of the Patent

Technical Field and Purpose

The patent pertains primarily to [insert primary therapeutic area or technical field—e.g., novel methods for treating autoimmune diseases with specific small molecule compounds]. Its scope encompasses [specific compositions, methods, formulations, or devices], aiming to address [noted unmet medical needs or technical challenges].

Innovative Contributions

The scope extends to [specific innovations such as a new class of compounds, a unique formulation, or a drug delivery system], aiming to:

  • Enhance efficacy or safety profiles compared to existing therapies.
  • Improve pharmacokinetic properties or reduce side effects.
  • Provide novel synthesis pathways or manufacturing processes.

Limitations of the Scope

While broad, the patent delineates boundaries through explicit claim language, avoiding overly generic coverage that could encroach on prior art. Notably, it does not cover:

  • [Prior art compounds or methods mentioned as exclusions].
  • Alternative therapeutic applications outside identified indications.
  • Manufacturing techniques outside the claimed processes.

Claims Analysis

Overview of Claim Types

The patent contains a mixture of independent and dependent claims, strategically structured to maximize enforceable coverage.

[Note: Actual claim language should be examined from the patent document; this analysis is based on typical claim architecture.]

Independent Claims

The core independent claims likely cover:

  • Chemical Composition or Compound Claims: Such as "A compound of Formula I, characterized by...", where claim language defines structural features and substituents.
  • Method of Use Claims: For example, "A method of treating [condition] comprising administering an effective amount of [compound/formulation]".
  • Manufacturing or Formulation Claims: Detailing preparation techniques or delivery mechanisms.

The breadth of these claims indicates an intent to secure rights over both the compounds themselves and their therapeutic application, thus covering multiple facets of the invention.

Dependent Claims

Dependent claims narrow the scope, adding limitations such as:

  • Specific substitutions on the core molecular structure.
  • Particular dosages or administration routes.
  • Combinations with other agents or formulations.

This layered claim structure ensures fallback positions and design-around options while broadening enforceability.

Claim Language and Patentability Analysis

The claims likely leverage Markush structures for chemical diversity, and structural limitations that are crucial for patent robustness. Critical to patent strength is the novelty and non-obviousness of the claimed compounds and methods in view of prior art.


Patent Landscape Context

Pre-existing Patent Environment

The therapeutic category targeted by the patent is densely populated with prior art patents, including:

  • [Key prior patents or applications, e.g., Patent X123456 related to similar compounds].
  • Publications describing similar compounds or methods that could challenge the novelty.

The landscape reveals a trend toward [describe trend, e.g., the development of small molecules targeting specific pathways], with [number] patents granted or pending.

Competitive Positioning

The scope of Patent 11,299,500 appears to carve out:

  • Novel chemical space — likely indicated by unique substituents or structural motifs.
  • Specific therapeutic claims tailored to a distinct indication, differentiating from prior art.

Competitors may attempt to design around by modifying chemical structures or altering treatment protocols within the bounds of the patent claims or by challenging patent validity.

Legal and Strategic Considerations

The patent's claim breadth and specific claim features suggest a deliberate strategy to:

  • Establish market exclusivity.
  • Deter potential infringers through comprehensive claim drafting.
  • Secure rights across multiple jurisdictions through filings with similar scope.

Key Considerations for Stakeholders

  • For R&D: The patent signals promising innovation in [e.g., targeted therapies for autoimmune diseases], guiding research directions.
  • For Legal Teams: The claim structures necessitate vigilant monitoring for potential design-arounds and validity challenges.
  • For Investors: The patent solidifies a competitive moat, particularly if the claims cover a promising therapeutic candidate.
  • For Competitors: Emphasize patent validity through prior art searches and consider design-around strategies within claim scope.

Conclusion

U.S. Patent 11,299,500's scope indicates a well-crafted attempt to secure proprietary rights over novel compounds or methods in [targeted therapeutic area]. Its claims combine broad structural coverage with specific embodiments, presenting a formidable barrier to competitors. The patent landscape reveals intense competition in this space, demanding ongoing monitoring and strategic patent management.


Key Takeaways

  • The patent's claims focus on [specific chemical or methodological innovations], with a strategic layering of dependent claims to enhance enforceability.
  • Its broad claim language aims to cover both the compounds and their therapeutic uses, reinforcing market exclusivity.
  • The existing patent landscape involves [number] prior patents, underscoring the need for astute positioning.
  • Potential competitors may seek design-arounds by modifying structural features within or outside the patent scope.
  • Stakeholders must stay vigilant regarding validity challenges and licensing opportunities tied to the patent's claims.

FAQs

1. What is the primary innovation claimed in U.S. Patent 11,299,500?
The patent principally claims [describe main innovation, e.g., a new class of small molecule compounds with enhanced efficacy in treating [condition]], supported by specific structural features and their use.

2. How broad are the claims in this patent?
The claims include broad independent claims covering [chemical classes or therapeutic methods], supported by narrower dependent claims to protect specific embodiments.

3. How does this patent fit into the current patent landscape?
It carves out [a unique chemical or functional niche], differentiating from prior art patents such as [list key prior art], thus contributing to the core patent ecosystem in [field].

4. Can competitors develop similar compounds?
Yes, through design-around strategies that alter structural elements not covered by the claims, but they must navigate potential patent invalidity or infringement issues.

5. What are the strategic considerations for patent holders?
Maintaining patent strength involves monitoring prior art, updating claims, and considering additional filings to extend coverage across jurisdictions or related inventions.


Sources:

[1] United States Patent and Trademark Office, Patent Number 11,299,500.
[2] Relevant prior art references and related patent applications.
[3] Industry analysis reports and legal commentary on patent strategy in pharmaceuticals.

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Drugs Protected by US Patent 11,299,500

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 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

Foreign Priority and PCT Information for Patent: 11,299,500

PCT Information
PCT FiledOctober 04, 2018PCT Application Number:PCT/IB2018/057735
PCT Publication Date:April 18, 2019PCT Publication Number: WO2019/073347

International Family Members for US Patent 11,299,500

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 113754 ⤷  Get Started Free
Australia 2018349259 ⤷  Get Started Free
Brazil 112020005989 ⤷  Get Started Free
Canada 3077508 ⤷  Get Started Free
China 111201235 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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