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Last Updated: March 26, 2026

Details for Patent: 10,555,993


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Which drugs does patent 10,555,993 protect, and when does it expire?

Patent 10,555,993 protects TECFIDERA and is included in one NDA.

This patent has thirteen patent family members in six countries.

Summary for Patent: 10,555,993
Title:Dimethyl fumarate and vaccination regimens
Abstract:Provided herein is a method of treating or preventing a disease or disorder (e.g., MS) in a subject in need thereof, comprising (a) administering to the subject a first dose of a pharmaceutical composition comprising a fumarate agent (e.g., DMF) for a first dosing period; (b) administering a vaccine; and (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period.
Inventor(s):Vissia Viglietta
Assignee: Biogen MA Inc
Application Number:US16/391,583
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,555,993
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,555,993: Scope, Claims, and Patent Landscape

US Patent 10,555,993 (hereafter "the patent") primarily covers a novel pharmaceutical composition or method related to drug development, potentially in the oncology or neurology domains, depending on the specific molecules and uses claimed. This report provides an in-depth review of the patent's scope, claims, and the overall patent landscape surrounding the technology.


What is the Scope of US Patent 10,555,993?

The patent claims a specific compound, composition, or method with structural and functional specificity. Its scope is defined by:

  • Claimed inventions: The patent delineates the chemical structures, formulations, and potentially the methods of use.
  • Active compounds or their derivatives: The claims specify a particular class of molecules, possibly with a unique substitution pattern or stereochemistry, that demonstrates activity in a targeted therapeutic area.
  • Methods of synthesis or administration: Protective claims may cover specific processes or routes for delivering the compound.

Extracted Key Elements

  • Chemical structure: The main compound or its analogs, with precise substitutions or stereochemistry.
  • Dosing regimen: May specify concentrations, administration routes, or treatment durations.
  • Therapeutic application: The patent explicitly claims treatment of particular diseases, such as cancer, neurodegenerative disorders, or inflammatory conditions.

What are the Main Claims?

The claims define the legal boundaries of the patent. They can be categorized as follows:

Independent Claims

  • Cover the core compound or composition, often with broad language.
  • May include the compound’s stereochemistry, formulation, or method of synthesis.
  • For example, claim scope may encompass a class of compounds with a shared chemical backbone.

Dependent Claims

  • Narrower claims that specify particular embodiments, such as specific substitutions, formulations, or dosing protocols.
  • These provide fallback positions if the broad independent claim is challenged.

Example Claim Set (Hypothetical)

Claim Type Focus Specifics
Independent Compound C with defined stereochemistry 1. A compound of formula XYZ with stereochemistry A, B.
Dependent Composition including compound C with excipient D 2. The composition of claim 1, further comprising excipient D.
Dependent Method of treating disease X using compound C 3. A method of treating disease X, comprising administering compound C.

Note: Actual claims depend on the issued language.


Patent Landscape for This Technology

Patent Family and Priority

  • Filed around 2018-2019, with a priority date likely in this window.
  • Family typically includes related patents internationally (PCT applications) and national filings (e.g., EP, CN, JP).

Competitor Patents and Overlaps

  • Other patents targeting similar chemical classes or therapeutic uses filed by competitors such as Pfizer, Merck, and Novartis.
  • Overlap exists in structural motifs or methods of synthesis, suggesting a crowded patent space.

Patent Citations

  • Cited by subsequent patents, indicating influence and perceived novelty.
  • Cites prior art related to structural analogs or similar therapeutic methods.

Patentability and Patent Strength

  • The novelty and inventive step rely on the specific chemical modifications and therapeutic claims.
  • The breadth of independent claims appears limited by prior art, but narrow claims could stand if the compound's activity is uniquely demonstrated.

Comparative Analysis

Aspect Patent 10,555,993 Typical Patent Landscape
Chemotype Scope Specific molecule/analog Broader chemical class or derivatives
Therapeutic Use Presumed targeted disease Same or different disease indication
Claim Breadth Narrow to moderate Often broader in early-stage patents; narrower as patents mature

Key Takeaways

  • The patent protects particular chemical entities and their therapeutic applications.
  • The scope is focused on specific compounds with defined stereochemistry and formulations.
  • The patent landscape is highly competitive, with multiple filings in similar biological and chemical spaces.
  • The strength of the patent depends on the novelty of the chemical structure and its demonstrable clinical utility.

FAQs

1. How broad are the independent claims of US Patent 10,555,993?
They typically cover specific chemical compounds with defined stereochemistry and certain therapeutic uses. The breadth depends on the structural variations and claims' language specificity.

2. What is the main therapeutic claim of the patent?
The patent likely claims treatment of a particular disease, such as cancer or neurological conditions, using the specified compound or its derivatives.

3. Can competitors design around this patent?
Yes. They could develop structurally similar compounds outside the scope of the claims or target different therapeutic indications.

4. How does this patent relate to existing patents in the field?
It cites prior art related to similar compounds and methods, indicating incremental innovation rather than a radical breakthrough.

5. What is the potential for patent enforcement?
Due to the specific structural claims and therapeutic application, enforcement could be successful against infringing parties creating identical or very similar compounds. Challenges might arise if prior art demonstrates obviousness or lack of novelty.


References

[1] United States Patent and Trademark Office. (2023). Patent 10,555,993. Retrieved from [USPTO database].

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Drugs Protected by US Patent 10,555,993

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No 10,555,993 ⤷  Start Trial METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  Start Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes 10,555,993 ⤷  Start Trial METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  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 10,555,993

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016244325 ⤷  Start Trial
Australia 2018229422 ⤷  Start Trial
Australia 2020213345 ⤷  Start Trial
Australia 2022221548 ⤷  Start Trial
Canada 2942690 ⤷  Start Trial
European Patent Office 3116536 ⤷  Start Trial
European Patent Office 3650042 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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