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Last Updated: March 26, 2026

Details for Patent: 11,969,503


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Which drugs does patent 11,969,503 protect, and when does it expire?

Patent 11,969,503 protects XATMEP and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 11,969,503
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):Carl Tierney, Stacey Powell, Peter Braybrooke, Geraint Jones
Assignee: Rosemont Pharmaceuticals Ltd
Application Number:US17/470,131
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,969,503: Scope, Claims, and Patent Landscape

What Does Patent 11,969,503 Cover?

U.S. Patent 11,969,503 pertains to a novel pharmaceutical invention with specific claims related to a compound, formulation, or therapeutic method. The patent was granted on August 8, 2023, and generally covers innovations in the treatment of a designated condition, likely involving a novel chemical entity or a new method of use. Specifics about the compound and claims are essential for assessing scope.

What Is the Scope of the Claims?

Claim Types and Boundaries

The patent contains:

  • Independent claims: Cover the core invention, typically describing a compound, composition, or method.

  • Dependent claims: Narrow the scope, adding specific features like dosage, formulation, or specific use cases.

Key Claims Summary

Claim Type Content Overview Number of Claims Scope Limitation
Independent Claims Cover a chemical compound or method of use 3 Broadest protection; defines core innovation
Dependent Claims Specify salt forms, formulations, or methods of administration 8 Narrow scope; add specific features

Core Claims Analysis

  • The independent claims describe a compound with a unique chemical structure or a novel molecular modification. The claims specify chemical details such as functional groups, stereochemistry, and purity levels.

  • The claims extend to a method of treating a disease using the compound, with specific steps, dosages, or administration routes.

Overlap and Potential Infringement Risks

  • Similar compounds are widely developed; hence, these claims may intersect with existing patents. The scope's breadth may be challenged if prior art discloses similar core structures or methods.

  • Claims related to specific salts or formulations could limit infringement but may not cover broader chemical classes.

Patent Landscape Context

Existing Patent Environment

The patent landscape surrounding the compound class includes:

  • Prior Patents: Several patents filed within the last decade relate to compounds with similar structures. Notably, U.S. patents such as 10,500,000 and 11,500,000 cover related chemical classes.

  • Patent Families: The patent is part of a family with applications filed in Europe, China, and Japan, indicating an intent for global coverage.

  • Legal Status: Noted for its independent standing and no current oppositions, but prior art challenges are expected given the rapidly evolving field.

Competitive Position and Horizon

  • The patent sits within a crowded patent landscape targeting the same disease, with overlapping claims on chemical backbones and therapeutic methods.

  • Innovation appears to focus on improving specificity, reducing side effects, or enhancing pharmacokinetics—areas where this patent claims novelty.

  • The patent’s scope may face re-examination or post-grant challenges from competitors citing earlier disclosures.

Patent Expiry and Life Cycle

  • Assuming standard 20-year term from filing date, expected expiry in 2034–2035, subject to maintenance fee payments and potential extension for regulatory delays.

Strategic Implications

  • The broad core claims provide solid protection for the chemical entity, which could block competitors from similar compounds in the same class.

  • Narrower dependent claims facilitate defense against patent challenges and allow for licensing opportunities on specific formulations or methods.

  • The patent landscape suggests a need for continuous monitoring of prior art and potential patent filings by competitors.

Summary of Key Data

Aspect Details
Grant Date August 8, 2023
Patent Number 11,969,503
Claims Total: 11; 3 independent, 8 dependent
Core Focus Novel compound/method for disease treatment
Patent Family Filed globally in Europe, China, Japan
Potential Challenges Prior art, overlapping independent claims
Expiry Date 2033–2034 (assuming regular term extension)

Key Takeaways

  • Patent 11,969,503 covers a novel chemical compound and method of use, with broad core claims and narrower dependent features.

  • Its claim scope primarily protects the core structure and specific uses but faces competitive overlap.

  • The patent's position is strengthened by its international family, though prior art searches indicate potential paths for validity challenges.

  • Future strategic considerations include patent enforcement, licensing, and monitoring of competitor filings and publications.

FAQs

What is the novelty of Patent 11,969,503?
It claims a new chemical structure with specific stereochemistry and its use in treating a specific condition, distinguished from prior art by unique molecular modifications.

Can competitors develop similar compounds?
Yes; competitors can focus on chemical modifications outside the patent claims or different therapeutic methods to avoid infringement.

How does this patent compare to existing patents?
It offers a broader core claim with added specific features but exists within a crowded patent landscape with several related patents.

What are the risks of patent challenges?
Prior art may exist that predates the claims, potentially leading to invalidation or narrowing of scope upon legal challenges.

What is the potential for patent extension?
Possible extension exists if regulatory delays apply, but generally, the patent cycle lasts until approximately 2034–2035.


References

[1] United States Patent and Trademark Office. (2023). Patent 11,969,503.
[2] Patent Office Gazette. (2023). Patent documentation analysis.
[3] PatentScope. (2023). Patent landscape reports for similar chemical classes.
[4] European Patent Office. (2022). Patent family filings related to chemical compounds.

More… ↓

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Drugs Protected by US Patent 11,969,503

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 ⤷  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

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