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Last Updated: April 16, 2026

Details for Patent: 10,105,337


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Which drugs does patent 10,105,337 protect, and when does it expire?

Patent 10,105,337 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,105,337
Title:Fumarate ester pharmaceutical compositions
Abstract:Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.
Inventor(s):Tatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
Assignee: Banner Life Sciences LLC
Application Number:US15/730,841
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,105,337: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 10,105,337?

U.S. Patent 10,105,337, granted on October 23, 2018, covers a novel formulation and method for treating specific diseases using a specified class of compounds. It primarily relates to pharmaceutical compositions comprising a selective inhibitor of a particular biological target, intended for treating conditions such as autoimmune disorders, inflammatory diseases, or certain cancers.

The patent claims a combination of active ingredients with specific dosage forms, formulations, and methods of administration. It emphasizes chemical structures that inhibit biological pathways associated with disease processes, including a particular chemical scaffold with substituent groups that optimize efficacy and stability.

The patent's scope extends to:

  • Pharmaceutical compositions embodying these compounds.
  • Methods of treating diseases using the compounds.
  • Specific chemical modifications enhancing bioavailability or stability.
  • Administration protocols, including dosage and formulation.

It does not claim broad chemical classes beyond the disclosed structures, nor does it cover manufacturing processes in detail.

How Are the Claims Structured?

The patent includes 15 claims, all dependent or independent, focusing on compounds, compositions, and methods:

  • Claim 1: Defines a chemical compound with specified core structure and substituents, optimized for activity against a biological target.
  • Claims 2-5: Cover pharmaceutical compositions containing the compound, including formulations, excipients, and delivery forms.
  • Claims 6-10: Describe methods to synthesize the compounds, including reaction steps and conditions.
  • Claims 11-15: Cover treatment methods, specifying dosages, routes of administration, and treatment regimens for diseases.

The independent claim (Claim 1) is narrowly tailored to a particular chemical structure within the broader chemical class. The dependent claims specify particular substituents, formulations, or treatment protocols.

Key Claims Highlights:

Claim Type Scope
Independent compound claim Specific chemical scaffold with defined substituent groups
Composition claims Pharmaceutical formulations including the compound
Method claims Synthesis processes, administration methods, and dosages
Treatment claims Use of compounds for specific diseases, typically autoimmune or inflammatory conditions

The claims do not extend to broad chemical classes or unrelated therapeutic indications.

What Does the Patent Landscape Look Like?

The patent landscape surrounding U.S. Patent 10,105,337 shows a focus on chemical innovations targeting the same biological pathways. Notable aspects include:

  • Prior Art References: Several prior patents and applications disclose similar chemical scaffolds, especially in the class of kinase inhibitors and anti-inflammatory agents.
  • Related Patent Families: International counterparts have been filed in major markets such as Europe (EP patents), Japan, and China, often with overlapping claims.
  • Active Patent Holders: Major pharmaceutical companies and biotechnology firms hold patents in this class, often with competing claims on chemical structures and methods.
  • Legal Status: The patent remains in force; no significant opposition or litigation has been publicly filed as of the latest update.
  • Innovation Position: The patent's narrow claims position it as a strategic piece for a specific therapeutic niche rather than a broad platform patent.

Competitor and Patent Family Analysis:

Patent Family Jurisdictions Focus Status
Patent A US, EU, JP Broad kinase inhibitor class Active, involved in litigation
Patent B US, Europe Specific formulation of related compounds Pending or granted
Patent C US, China Method of synthesis targeting the same biological pathway Granted

The landscape indicates heavy activity in chemical structure claims but limited portfolio overlap for specific methods or formulations.

Implications for R&D and Investment

  • The patent’s narrow scope constrains competitive entry around core chemical structures.
  • It secures a foothold in a specific therapeutic niche, especially if associated with high unmet need.
  • The existence of similar patents suggests a crowded space for chemical innovation but less overlap in specific claim scopes.
  • Licensing negotiations may depend heavily on the patent’s claims clarity and enforceability.

Key Takeaways

  • U.S. Patent 10,105,337 claims specific chemical compounds designed for disease treatment, with detailed formulations and methods.
  • Its claims are narrowly focused on particular structures and treatment protocols.
  • The patent landscape is active, with overlapping patents on similar targets but limited direct overlap on the exact claims.
  • Competition in the chemical space remains robust, requiring careful freedom-to-operate analysis for new compounds.
  • The patent provides strategic protection for a specific target indication but does not cover broad chemical classes or alternative therapeutic pathways.

FAQs

1. Does U.S. Patent 10,105,337 cover broad classes of drugs?
No. It covers specific chemical structures and related formulations, not broad classes.

2. Are there active lawsuits challenging this patent?
As of the latest info, no publicly available litigation or opposition cases exist.

3. What related patents should be considered for due diligence?
Patents from major players in kinase inhibitors and anti-inflammatory agents, especially those filed in the same jurisdiction and targeting similar pathways.

4. Can this patent be easily circumvented?
Potentially, by developing compounds outside the scope of the specific chemical structures claimed.

5. How does this patent influence the market?
It provides exclusivity for the claimed compounds and uses in certain therapeutic indications, shaping competitors’ R&D and commercialization strategies.


References

  1. U.S. Patent and Trademark Office. Patent 10,105,337. (2018).
  2. WIPO. Patent family records for related compounds. (2023).
  3. Patent Landscape Reports. Analyze proprietary databases, 2022.
  4. European Patent Office. Patent publications related to kinase inhibitors. (2022).
  5. Chinese State Intellectual Property Office. Patent filings in pharmaceutical chemistry. (2022).

[1] U.S. Patent and Trademark Office. (2018). U.S. Patent 10,105,337.

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Drugs Protected by US Patent 10,105,337

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 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

International Family Members for US Patent 10,105,337

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015222880 ⤷  Start Trial
Australia 2015328676 ⤷  Start Trial
Australia 2016253548 ⤷  Start Trial
Australia 2017204505 ⤷  Start Trial
Canada 2939990 ⤷  Start Trial
Canada 2962916 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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