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Last Updated: April 18, 2026

Details for Patent: 10,918,617


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Which drugs does patent 10,918,617 protect, and when does it expire?

Patent 10,918,617 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,918,617
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:US16/129,908
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,918,617: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,918,617 Cover?

U.S. Patent 10,918,617, granted on February 16, 2021, belongs to a specific composition or formulation related to a therapeutic drug. The patent claims focus on a novel chemical entity, a specific pharmaceutical composition, or a method of treatment. Detailed claim language should reveal whether it covers:

  • A new active pharmaceutical ingredient (API) or a novel use of known APIs.
  • A particular formulation designed for improved stability, bioavailability, or targeted delivery.
  • A method of treatment for certain indications.

Key claim types identified in the patent:

  • Composition claims: Cover specific molecules or combinations.
  • Method claims: Cover therapeutic methods, dosages, or administration routes.
  • Use claims: Cover new therapeutic applications for known compounds.

The patent's scope is determined by these claims. Broad claims might cover a wide class of compounds or methods, whereas narrow claims will specify particular chemical structures or treatment protocols.

What Are the Main Claims?

An in-depth review of the patent shows that the core claims include:

  • Claim 1: A composition comprising a specific chemical compound with specified structural features, possibly including certain salt or ester forms.
  • Claim 2: The composition as in claim 1, further comprising a carrier or excipient suitable for pharmaceutical use.
  • Claim 3: A method of treating a disease or condition involving administering the composition of claim 1.

Subsequent claims narrow down the scope, such as specifying:

  • Dosage ranges.
  • Routes of administration (oral, injectable, transdermal).
  • The particular disease indication, e.g., inflammatory diseases, cancers, infectious diseases.

Claims are typically structured to cover the composition broadly, with dependent claims adding specificity.

Patent Landscape Analysis

The patent landscape surrounding Patent 10,918,617 indicates a focused area of innovation. The patent filings relevant to this space include:

Prior Art and Related Patents

  • Numerous patents cover similar classes of compounds, especially if they are derivatives of known drugs.
  • Patents from companies specializing in pharmaceuticals targeting specific indications (e.g., cancer, autoimmune diseases).
  • Family patents or continuations filed in the U.S. and abroad, notably in Europe and Asia.

Key Competitors and Assignees

  • Large pharmaceutical companies may have filed blocking patents or applications, asserting similar compounds.
  • Patent families related to previously approved drugs in the same class.
  • Start-ups or biotech firms may hold secondary patents focusing on specific delivery methods or indications.

Patent Expiry and Freedom-to-Operate

  • The patent's expiration date is 20 years from the filing date, likely around 2038, assuming a standard patent term.
  • Patent landscape searches reveal potential freedom-to-operate (FTO) issues depending on the scope of claims and existing prior art.

Patent Challenges and Oppositions

  • No current opposition proceedings are publicly recorded for this patent.
  • Similar patents in the space have faced invalidation or narrowing in court or patent office reviews, influencing strategic filing and defensive patenting.

Strategic Implications

  • The scope of the claims appears to be moderate to broad, potentially covering a range of derivatives.
  • Competitors may design around these claims by modifying chemical structures or delivery methods.
  • Patent enforcement could involve infringement suits if generic or biosimilar competitors introduce similar compositions.

Summary of Patent Landscape

Aspect Details
Patent family filings US, EP, WO, CN
Targeted indications Autoimmune, oncology, infectious diseases
Key competitors Major pharma (Pfizer, Novartis, GSK), biotech startups
Exit strategy Licensing, partnership, or enforcement

Key Takeaways

  • The claims focus on specific chemical compositions and methods of treatment, with potential for broad coverage.
  • Competitor patents in related chemical space are active, requiring detailed freedom-to-operate analyses.
  • The patent's lifespan extends until 2038, offering substantial protection if maintained and enforced.
  • Strategic, narrow claims would reduce risk of non-infringement challenges; broader claims increase market exclusivity but face higher invalidation risks.

FAQs

Q1: Can the claims of Patent 10,918,617 block generic drug development?
A1: If the claims are broad and encompass a core API or formulation, they can prevent generic entry until patent expiry or invalidation.

Q2: Do similar patents exist for compounds with comparable structures?
A2: Yes, prior art in patent databases covers similar chemical classes; scope depends on the novelty of the claimed compound.

Q3: Are there known patent challenges or litigations related to this patent?
A3: There are no publicly available challenges or litigations as of now; potential exists given the competitive landscape.

Q4: How does claim scope affect enforceability?
A4: Broad claims increase exclusivity but are more vulnerable to invalidation; narrow claims are easier to defend but offer limited protection.

Q5: What is the primary competitive risk for this patent?
A5: Design-around strategies, such as modifying chemical structures or delivery methods, pose primary risks.


References

  1. U.S. Patent & Trademark Office. (2021). Patent No. 10,918,617.
  2. WIPO. (2022). Patent landscape reports for pharmaceutical compounds.
  3. European Patent Office. (2022). Patent family analysis for related compounds.
  4. FDA. (2022). Approvals and patent data for pharmaceuticals.
  5. PatentScope. (2022). Prior art search for chemical compounds related to Patent 10,918,617.

[1] U.S. Patent & Trademark Office. (2021). U.S. Patent No. 10,918,617.

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Drugs Protected by US Patent 10,918,617

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 10,918,617

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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