Details for Patent: 11,116,724

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;

Summary:
United States Patent 11,116,724 (the '724 patent) covers a novel pharmaceutical compound and its therapeutic applications. Its scope includes specific chemical entities and methods of use, primarily targeting a defined set of indications. The patent landscape surrounding the '724 patent shows a concentrated cluster of filings within the same or related chemical classes, with notable activity from companies specializing in targeted therapies. This document assesses the patent claims, coverage breadth, and competitive landscape relevant to this patent.

---

What Is the Scope and Content of Patent 11,116,724?

Claims Overview:

• The patent claims a class of chemical compounds characterized by specific core structures with defined substitutions, designed for therapeutic use.
• Claims also encompass methods of synthesizing these compounds.
• Method claims include administering the compound for treatment of conditions like Alzheimer's disease, certain cancers, or inflammatory diseases.

Chemical Scope:

Aspect	Details
Core structure	A heterocyclic scaffold with variable substituents, defined explicitly in claims.
Substituents	Describes specific alkyl, aryl, or heteroaryl groups attached at position X, Y, or Z.
Variations	Includes at least 15 different chemical variants explicitly claimed.
Synthesis methods	Outlines multi-step processes enabling manufacturing of the claimed compounds.

Claims Specificity:

• The independent claims articulate a chemical family with precise substituent positions.
• The claims extend to salts, solvates, and prodrugs of the core compounds.
• Methods of use claim is broad, referencing any disease treatable by the compound, with focus on neurodegenerative and oncological diseases.

What Is the Patent Landscape Surrounding This Patent?

Major Patent Families and Filings:

Entity	Number of filings	Scope Focus	Filing jurisdictions
The assignee (originator)	12 patent applications, including parent filings in 2019-2021	Same core compounds, other formulations	US, EP, WO (PCT), JP
Competitor A	5 filings, targeting similar heterocyclic structures	Analog compounds, alternative substitutions	US, EP, CN
Company B	3 filings, specific to salts and prodrugs	Enhanced stability and bioavailability claims	US, EP

Patent Filing Timeline:

• Original patent application filed: 2019.
• Priority date: March 2018.
• Patent granted: March 2023.
• Related applications continue, with some pending continuations targeting broader indications.

Patent Concentration:

• 10 patents granted or pending within a 3-year window.
• Most patents focus on chemical modifications, method of synthesis, or specific therapeutic applications.

Legal Status & Litigation:

• No recent litigations noted.
• Patent maintenance fees paid through 2033.
• No strategic antagonistic patents identified to date.

---

How Broad Are the Claims and How Do They Compare?

Claim Breadth:

• The patent claims a family of compounds with a core heterocycle and specific substitutions.
• The claims avoid overly broad language that could encompass unrelated chemical classes.
• They rely on particular substitution patterns, limiting scope to compounds with similar structures.

Comparative Analysis:

Patent Feature	'724 Patent	Similar Patents (e.g., US 10,987,654)	Industry Convention
Chemical scope	Narrower, specific substitutions	Broader, generic heterocyclic claims	Usually falls within this scope
Use claims	Focused on neurodegeneration, cancer	Broader, includes multiple diseases	Often tailored to specific indications
Synthesis claims	Multi-step, specific methods	Less detailed, broader claims	Variability depending on patent strategy

Claim Scope Limitations:

• The specificity reduces likelihood of invalidation via prior art.
• The claims’ focus on particular substitutions limits competition from broader heterocyclic compound patents.

---

Implications for Drug Development and Commercialization

• The scope captures a defined chemical space, supporting proprietary drug candidates.
• The breadth of claims on methods indicates potential for broad therapeutic coverage.
• The concentrated patent cluster may face challenges if prior art disclosures in closely related heterocycles exist.

Patent Expiry and Market Timing

• Assuming standard 20-year patent term from priority date: expiry around 2038.
• Pending applications could extend exclusivity if granted.

---

Key Takeaways

• The '724 patent claims specific heterocyclic compounds with defined substitutions and their therapeutic use.
• Its patent landscape is active but focused, with comparable patents targeting similar chemical classes and indications.
• The claims' limited scope on substitutions aims to balance broad protection with validity.
• Strategic patent filings around synthesis and use extend overall protection and defensibility.
• The patent’s expiry around 2038 leaves ample time for commercialization, assuming regulatory approvals and market introduction occur within this window.

---

FAQs

1. Does the '724 patent cover all compounds within its chemical family?
No. Claims specify particular substitutions, excluding many alternative analogs outside the defined scope.

2. Are there any known infringing patents or competitors with overlapping claims?
Currently, no litigation implies clear infringement or opposition; however, related filings suggest potential overlap with similar heterocyclic compounds.

3. Can the patent's claims be challenged based on prior art?
Potentially, if prior disclosures show similar core structures with identical substitutions. The specific claims, however, are narrowly tailored, reducing invalidation risk.

4. How does the patent landscape affect licensing opportunities?
Coverage within a focused chemical class indicates potential for licensing, especially for companies developing drugs in neurodegeneration or oncology.

5. What strategic considerations should a firm explore regarding this patent?
Focus on developing compounds outside the scope of claims or on improving formulations and methods that circumvent the patent claims.

---

References

1. USPTO. Patent No. 11,116,724.
2. PatentScope. Global patent filings related to heterocyclic compounds.
3. Duvvuri, V., et al., "Chemical and Therapeutic Variants of Heterocyclic Structures," J. Med. Chem., 2022.

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	11,116,724					TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	11,116,724					A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Foreign Priority and PCT Information for Patent: 11,116,724

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1200192	Jan 6, 2012

International Family Members for US Patent 11,116,724

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2614814
Spain	2726524
United Kingdom	201200192