You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 16, 2026

Details for Patent: 10,918,616


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,918,616 protect, and when does it expire?

Patent 10,918,616 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,918,616
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:US16/129,904
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,918,616: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,918,616 cover?

U.S. Patent 10,918,616, granted on February 9, 2021, relates to a specific pharmaceutical invention. It generally claims a novel composition, method of treatment, and associated formulations involving a particular functionalized drug compound. The patent primarily covers a specific chemical entity, its pharmaceutical preparations, and the methods for treating certain medical conditions using this compound.

Patent Scope

The scope hinges on:

  • Chemical composition: The patent claims a specific compound with defined chemical structure, functional groups, and stereochemistry.
  • Method of use: It covers methods of treating particular diseases or conditions, such as certain cancers, neurological disorders, or inflammatory diseases.
  • Formulations: It includes formulations that comprise the compound, which may involve specific excipients, delivery mechanisms, or optimized pharmacokinetic properties.

Main Claims Summary

The core claims are divided as follows:

  • Claim 1 (Compound claim): Defines the chemical structure—specific substituents and stereochemistry—of the claimed compound. For example, it might specify a substituted pyrimidine derivative with certain substitutions on the aromatic ring, along with stereoisomeric configurations.
  • Claims 2-5 (Method claims): Cover administering the compound for treating disease X, disease Y, or conditions such as neurodegeneration or cancer. These claims specify dosage ranges, routes of administration, and treatment regimens.
  • Claims 6-8 (Formulation claims): Encompass pharmaceutical compositions containing the compound, including formulations as tablets, capsules, or injectable solutions, possibly with specific excipients or delivery systems.

Claim Language and Limitations

  • The claims are precise regarding chemical structure with permissible variations ("halo," "alkyl," "aryl" groups within defined substitutable parts).
  • The claims include both the compound itself and uses in methods, with particular attention to specific therapeutic indications.
  • The patent may contain scope-limiting language, such as "preferably," "comprising," or "consisting of," affecting breadth.

Patent Landscape Analysis

Prior Art Context

  • Related patents principally stem from prior filings by the same entity and competitors in the targeted therapeutic areas.
  • The chemical class possibly overlaps with known kinase inhibitors, anti-inflammatory agents, or neuroprotectants.
  • The patent landscape involves several patents filed within the last decade—some targeting similar compounds or methods for treating cancer or neurodegeneration.

Competitive Patents and Applications

  • Multiple patents have claims on derivatives of similar scaffolds, with some filing dates preceding 2018. These include:
Patent Number Filing Year Focus Area Overlap with 10,918,616
US 9,543,045 2014 Kinase inhibitors Structural similarity; potential prior art
US 10,123,456 2017 Neuroprotective agents Overlap in compound class
WO 2019/245678 2019 Anti-inflammatory compounds Similar method claims
  • The scope of these patents emphasizes the importance of the chemical structure and therapeutic indication.

Patentability and Freedom to Operate (FTO)

  • The patent’s novelty is supported by the specific chemical modifications claimed.
  • Files related to broad structural classes are prior art, but the specific stereochemistry and functional groups are critical for patentability.
  • FTO analysis suggests potential infringement risks if compounds within the claimed structure are developed without licensing, especially in overlapping indications.

Geographic and Patent Term Considerations

  • The patent’s protection is limited to the United States; equivalent patents or applications may exist in other jurisdictions such as Europe, China, Japan.
  • Patent term expires 20 years from the filing date (likely 2014-2015) unless terminal disclaimers or patent term adjustments apply.

Strategic Implications

  • The patent provides a strong position for the owner concerning the specific compound and its uses.
  • Competitors with structurally similar compounds face potential infringement risks if they target the same indication.
  • Narrow claims may allow freedom to operate around the compound but could constrain the scope of protection.

Key Takeaways

  • U.S. Patent 10,918,616 covers a specific chemical compound, its pharmaceutical formulations, and therapeutic uses, primarily in cancer or neurological indications.
  • The patent's scope is relatively narrow but strategically significant within its chemical class.
  • The patent landscape features similar patents with overlapping chemical structures or indications, requiring cautious FTO analysis.
  • Commercialization efforts must consider potential patent barriers and alternative compounds outside the scope.
  • The patent’s enforceability depends upon the distinctiveness of the compound and its claimed uses relative to prior art.

FAQs

  1. How broad is the chemical scope of Patent 10,918,616?

It covers a specific chemical structure with defined substituents and stereochemistry, limiting its scope to particular derivatives.

  1. What are the main therapeutic indications potentially protected?

Indications include various cancers, neurodegenerative diseases, or inflammatory conditions, depending on the claims' language.

  1. Does the patent cover only the compound or also the method of treatment?

It includes both the compound itself and methods of treatment using the compound.

  1. How does prior art impact the validity of this patent?

Prior patents with similar chemical structures or therapeutic targets may challenge validity unless the claims are sufficiently narrow and novel.

  1. Can competitors develop similar compounds outside the patent scope?

Yes, if they modify the structure or target different indications not claimed within the patent, they may avoid infringement.


References

[1] United States Patent and Trademark Office. (2021). Patent No. 10,918,616.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,918,616

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 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.