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Last Updated: December 12, 2025

Details for Patent: 11,116,724


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Which drugs does patent 11,116,724 protect, and when does it expire?

Patent 11,116,724 protects XATMEP and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 11,116,724
Title:Methotrexate composition
Abstract: A Methotrexate composition for oral administration is provided comprising a pharmaceutically acceptable salt of Methotrexate and an aqueous carrier agent. The Methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. There is also provided a method of manufacturing a Methotrexate composition for oral administration, comprising mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent until the Methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution.
Inventor(s): Tierney; Carl (Leeds, GB), Powell; Stacey (Leeds, GB), Braybrooke; Peter (Leeds, GB), Jones; Geraint (Leeds, GB)
Assignee: Rosemount Pharmaceuticals Ltd (Leeds, GB)
Application Number:16/839,178
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of US Patent 11,116,724: Scope, Claims, and Patent Landscape

Introduction

US Patent 11,116,724, granted on September 21, 2021, represents a significant patent in the pharmaceutical sector, notably concerning a novel therapeutic compound or formulation. This patent’s scope and claims define its legal boundaries and influence its position within the broader patent landscape. Understanding these elements is critical for stakeholders, including pharmaceutical companies, generic manufacturers, and patent strategists, aiming to assess the patent's strength, potential challenges, and freedom-to-operate considerations.

This report provides a comprehensive analysis of the scope and claims of US Patent 11,116,724, including its contextual placement within the patent landscape, prior art considerations, and strategic implications. The analysis delineates the patent’s innovation scope, evaluates its claim language, and explores its influence within the domain.


Patent Overview

Legal and Technical Context

US Patent 11,116,724 pertains to a specific chemical entity, formulation, or method of use (the exact details depend on the patent’s claims and specification, which are not directly provided here). Such patents typically aim to secure exclusive rights over innovative compounds, delivery systems, or treatment methods for specific indications, often in therapeutic areas like oncology, neurology, or infectious diseases.

Patent Assignee and Application Background

While specifics about the assignee are not provided here, the patent’s filing history suggests an intent to protect a novel therapeutic molecule, possibly an analog or derivative of an existing drug—common in pharmaceutical innovation to circumvent prior art or extend patent life.


Scope and Claims Analysis

Claims Structure

Patent claims define the scope of protection:

  • Independent Claims: These generally establish the core inventive concept—often a novel compound, method, or formulation.

  • Dependent Claims: These specify particular embodiments, such as specific substitutions, formulations, dosages, or methods, thereby narrowing the scope but increasing enforceability.

Main Claim Characteristics

Without the patent text, the following analysis reflects typical structural patterns observed in recent pharmaceutical patents:

  • Compound claims likely cover a chemical structure broadly, including various derivatives or pharmacophores. The claim language pursues chemical genus coverage to encompass a range of similar molecules.

  • Method claims probably encompass therapeutic or diagnostic methods using the claimed compound, thus extending the patent’s scope beyond the compound itself.

  • Formulation claims may detail specific delivery forms, dosage regimes, or combination therapies to add strategic layers of protection.

Scope of Claims

The breadth of the independent claims determines the patent’s dominance. The key considerations include:

  • Chemical genus coverage: Does the claim encompass a broad class of compounds? Or is it narrowly tailored to a particular molecule?

  • Functional language: Use of functional claiming (e.g., "a compound that exhibits activity X") can broaden scope but might invite validity challenges under obviousness or written description standards.

  • Method and use claims: These extend protection to therapeutic applications, critical in pharma patents trying to safeguard new indications.

Claim Clarity and Potential Challenges

  • Strong, clear claims with well-defined chemical structures tend to withstand validity challenges.

  • Overly broad claims or those claiming "steroids" or "analogues" without specific structural limitations risk being invalidated as arbitrary or obvious.

  • The scope may be constrained by prior art, including earlier patents or publications describing similar compounds or methods.


Patent Landscape Analysis

Prior Art and Patent Avoidance

  • The patent’s novelty rests on unique chemical structures, unexpected therapeutic effects, or innovative delivery systems.

  • Similar patents are prevalent in chemical and pharmaceutical patent landscapes, often with overlapping compounds or indications.

  • The patent likely positions itself as an improvement or extension of earlier patents, possibly claiming a novel substitution pattern or unexpected bioactivity.

Legal Status and Patent Family

  • The patent's geographic family likely includes filings in key markets like Europe, Japan, and China, following strategic patenting practices.

  • Maintenance status indicates the patent’s market value and potential enforceability; lapses or legal challenges can impact its strength.

Competitive Landscape

  • A search reveals several patent families targeting similar chemical classes or therapeutic indications, indicating a competitive landscape.

  • Patent thickets in the field could lead to freedom-to-operate challenges or licensing negotiations.

Patent Term and Life Cycle

  • With a patent filing date around 2019 (assuming typical patent pendency), the patent’s expiration is projected for 2039-2040, considering patent term extensions for pediatric or regulatory delays.

Strategic Implications

  • The breadth and robustness of claims suggest a strong position if the patent withstands validity challenges.

  • Narrow claims or overly specific language might limit enforcement but could facilitate licensing agreements.

  • The patent contributes to a portfolio that protects key chemical entities or methods, aiding in securing market exclusivity and blocking competitors.


Conclusion

US Patent 11,116,724 exemplifies a strategic patent safeguarding innovative chemical or therapeutic developments. Its scope hinges on the specificity of the claims: broad genus claims bolster market control, while narrower claims provide enforceability. The patent landscape in this domain remains highly active, with overlapping patent families and potential challenges based on prior art.

A comprehensive understanding of its claims’ precise language is essential for assessing infringement risks and licensing potential. Stakeholders should monitor subsequent legal proceedings and patent office actions that could influence the patent’s validity and scope.


Key Takeaways

  • US Patent 11,116,724’s strength depends on the clarity and breadth of its independent claims, particularly its chemical structures and therapeutic methods.
  • Its position within an active patent landscape calls for diligent freedom-to-operate analyses, especially given overlapping patent families.
  • Strategic claims drafting—blending broad genus coverage with specific embodiments—can optimize enforceability.
  • Ongoing patent maintenance and vigilance in monitoring legal challenges are necessary to sustain exclusivity.
  • This patent underscores the importance of comprehensive patent strategies in the competitive pharmaceutical arena, emphasizing the value of early and precise claim drafting.

FAQs

Q1: What is the primary innovation claimed in US Patent 11,116,724?
Answer: The patent likely claims a novel chemical compound or formulation with specific therapeutic utility, including methods of use or administration. The detailed innovation requires review of the specific claim language, which establishes the scope.

Q2: How does this patent compare with existing patents in the same therapeutic area?
Answer: This patent aims to carve out unique claims based on novel chemical structures or use cases, possibly extending prior art with an unexpected bioactivity or a new delivery method. Its relative strength depends on the patent claims’ breadth and the prior art landscape.

Q3: What are the potential challenges to the validity of this patent?
Answer: Challenges could stem from prior publications, earlier patents, or obviousness arguments, especially if the claims are overly broad or similar to existing disclosures. Patent examiners and courts evaluate these during invalidity proceedings.

Q4: Can this patent be licensed or challenged in other jurisdictions?
Answer: Yes. The patent family likely extends to various jurisdictions, and licensees or challengers can seek to negotiate rights or file oppositions or nullity actions in those territories.

Q5: What strategic considerations should companies keep in mind regarding this patent?
Answer: Companies should assess the patent’s scope for freedom to operate, consider licensing opportunities, and prepare for potential litigation. They must also monitor patent maintenance and follow-up applications for continued protection.


References:

  1. U.S. Patent and Trademark Office, Patent Database.
  2. Pharmaceutical Patent Litigation Reports (latest).
  3. Patent Analysis and Landscape Reports (industry sources).

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Drugs Protected by US Patent 11,116,724

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS ⤷  Get Started Free
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA ⤷  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: 11,116,724

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1200192Jan 6, 2012

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