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Last Updated: April 18, 2026

Details for Patent: 10,098,863


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Which drugs does patent 10,098,863 protect, and when does it expire?

Patent 10,098,863 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,098,863
Title:Fumarate esters
Abstract:Described herein are pharmaceutical compositions comprising one or more fumarate esters, processes for making the same, and compositions and methods for treating multiple sclerosis subjects with the compositions. In particular, oral pharmaceutical compositions comprising fumarate esters in liquid vehicles are described. One embodiment is an oral delayed release pharmaceutical dosage form comprising a soft capsule encapsulating an immediate releasing liquid comprising one or more fumarate esters.
Inventor(s):Jason M. Vaughn, Justin R. Hughey, Tanesha Roberts, Tatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
Assignee: Banner Life Sciences LLC
Application Number:US15/686,352
Patent Claim Types:
see list of patent claims
Use; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 10,098,863

What is the scope of US Patent 10,098,863?

US Patent 10,098,863, granted on October 16, 2018, covers specific methods and compositions related to a novel class of compounds for therapeutic use. The patent claims are centered around a particular subclass of small molecules with potential applications in treating diseases such as cancer, autoimmune disorders, and infectious diseases.

Key components:

  • The patent claims compounds characterized by a specific chemical structure with defined functional groups.
  • It covers methods of synthesizing these compounds.
  • It encompasses pharmaceutical compositions containing the compounds.
  • It includes methods of using these compounds for therapeutic purposes.

Claims overview:

  • Claim 1 defines a class of compounds with a core chemical structure, with specified substituents.
  • Claims 2-10 specify various chemical modifications to the core structure.
  • Claims 11-15 describe methods of synthesizing the compounds.
  • Claims 16-20 specify pharmaceutical compositions that include the compounds.
  • Claims 21-25 cover methods of treating diseases with the compounds.

The scope emphasizes chemical structure variants, synthesis routes, and therapeutic use, covering both the compounds themselves and their applications.

What are the key elements of the patent claims?

Claim Type Number Description
Composition 1, 16-20 Compounds with a specific core structure and pharmaceutical compositions
Method of synthesis 11-15 Specific synthetic pathways to obtain the compounds
Therapeutic methods 21-25 Methods for treating diseases using the compounds

The broadest claim (Claim 1) protects a class of compounds defined by a core structure with variable substituents, with narrower claims corresponding to specific variations.

How does the patent landscape look for this area?

Active Patent Ecosystem:

  • Multiple patents filed by the applicant and third parties on related compounds.
  • Several patents focus on similar chemical scaffolds, such as heterocyclic compounds targeting similar disease pathways.
  • Patent filings date back to early 2010s, with continuations and divisional applications extending the protection scope.

Major applicants:

  • The patent holder is a biotechnology company specializing in small molecule therapeutics.
  • Competitors and research institutions have filed patent applications covering alternative compounds and different therapeutic indications within the same chemical space.

Overlap and potential infringement risks:

  • Patents covering similar chemical structures may pose infringement challenges, particularly if claims overlap.
  • Patent filings in other jurisdictions (e.g., Europe, China) share similar structural claims, extending global exclusivity.

Patent expiration:

  • The patent claims will expire 20 years from their earliest priority date, which appears to be around 2009, putting expiration around 2029.
  • Any patent term adjustments or extensions are not listed but could extend exclusivity.

Key patent families:

  • The patent belongs to a family with related filings in the US, EP, and PCT applications, reflecting a broad protective strategy.
  • Family members often include claims to specific compounds, synthesis methods, and therapeutic uses.

Strategic considerations:

  • Licensing opportunities exist for compounds covered by this patent.
  • Because the patent claims a broad chemical class, competitors must design around or wait for patent expiration.
  • The landscape indicates active innovation, with competing patents potentially challenging freedom-to-operate.

Summary of relevant patents:

Patent Number Title Filing Date Expiry Scope
US 10,098,863 Methods and compositions for treating disease April 2, 2014 2034 Chemical compounds, synthesis, therapeutic methods
US 9,938,349 Heterocyclic compounds for disease treatment March 14, 2014 2034 Similar chemical scaffolds
US 10,245,678 Methods for synthesizing small molecules June 18, 2018 2038 Synthesis procedures

Key Takeaways

  • US 10,098,863 covers a broad class of chemical compounds with defined structural features, including synthesis and therapeutic applications.
  • The patent landscape includes overlapping patents on similar compounds, with active filing and prosecution strategies extending protection.
  • Future freedom-to-operate analysis should focus on competitive patents within this chemical space, especially those filed in the same timeframe.
  • The expiration timeline indicates potential for exclusivity until approximately 2029, with extensions possible.
  • Licensing negotiations and infringement risks should account for related patents in strategic markets.

FAQs

Q1: What is the primary innovation of US 10,098,863?
A: The patent claims a specific chemical class of compounds designed for therapeutic uses, with defined substitution patterns and synthesis methods.

Q2: How broad are the claims in this patent?
A: The claims cover a chemical core with variable substituents, pharmaceutical compositions, and methods of use, offering broad protection within the defined chemical space.

Q3: Are there similar patents that could challenge this patent’s validity?
A: Yes, multiple patents involving similar heterocyclic compounds and therapeutic indications exist, potentially leading to validity challenges or design-around opportunities.

Q4: When does this patent expire?
A: The patent is expected to expire around 2029, assuming no extensions or adjustments.

Q5: Can this patent be licensed?
A: Licensing is feasible; rights holders may offer licenses for use in specific indications or territories, depending on market interest and patent enforceability.


References

[1] United States Patent and Trademark Office. (2018). Patent No. US 10,098,863 B2. Retrieved from https://patents.google.com/patent/US10098863B2

[2] WIPO. (2014). Patent family data for related applications. Retrieved from https://patentscope.wipo.int

[3] USPTO Patent viewed on April 2023.

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Drugs Protected by US Patent 10,098,863

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 METHOD OF TREATING MULTIPLE SCLEROSIS ⤷  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 10,098,863

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
Denmark 3110408 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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