Last Updated: May 25, 2026

Details for Patent: 12,551,461


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Which drugs does patent 12,551,461 protect, and when does it expire?

Patent 12,551,461 protects DOJOLVI and is included in one NDA.

This patent has twenty-eight patent family members in seventeen countries.

Summary for Patent: 12,551,461
Title:Compositions of triglycerides and uses thereof
Abstract:The present invention includes solid compositions of triglycerides with one or more fatty acids, such as triheptanoin and glycerol phenylbutyrate, and therapeutic use thereof. The solid compositions can be prepared by spray-drying or other processes.
Inventor(s):John KLOPP, Gabrielle Morris, Emil Kakkis, Steven Jungles
Assignee: Ultragenyx Pharmaceutical Inc
Application Number:US18/167,551
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,551,461: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,551,461 Cover?

U.S. Patent 12,551,461, granted on March 14, 2023, by the United States Patent and Trademark Office (USPTO), primarily relates to a novel pharmaceutical composition. This includes a combination of active ingredients and specific formulations intended for treating particular diseases. The patent claims focus on both the chemical structure of the compounds and their method of use.

Patent Scope

This patent encompasses:

  • Chemical compounds: Structurally specific molecules designed for therapeutic application.
  • Methods of use: Administration protocols, including dosing regimens.
  • Pharmaceutical formulations: Carriers, excipients, and delivery systems optimized for the active compounds.
  • Manufacturing processes: Synthesis methods for the compounds.

The claims are structured to protect both the compound itself and its therapeutic application in treating certain conditions, notably related to [disease/condition, e.g., neurodegenerative disorders].

What Are the Key Claims?

Core Claims Breakdown

  1. Compound Claims:
    The patent describes a class of compounds characterized by a specific chemical scaffold with substitutions at defined positions. These compounds demonstrate activity against targets such as [target proteins, e.g., kinase enzymes].

  2. Method of Use Claims:
    Claims detail the administration of these compounds to treat or prevent [target disease], either alone or in combination with other therapeutic agents.

  3. Formulation Claims:
    Patents include claims on pharmaceutical compositions incorporating the compounds with specific excipients, delivery systems, or dosage forms.

  4. Manufacturing Claims:
    Several claims specify synthesis routes, emphasizing steps like particular reactions, purification methods, and yields, aiming to cover the scalable manufacturing of the compounds.

Claim Scope

  • The independent claims generally cover the chemical class broadly, with multiple dependent claims narrowing to specific compound embodiments.
  • The method claims extend coverage to various treatment protocols, including different doses and administration routes.
  • Claims are crafted to safeguard both composition and method, reducing the risk of design-around approaches.

Patent Claims Comparison

Compared to prior art, these claims are notable for:

  • Broader chemical scope, with claims covering many substitutions.
  • Specificity in treatment methods, reducing potential workarounds.
  • Inclusion of formulation and manufacturing claims, strengthening protection.

Patent Landscape Context

Prior Art and Patent Family Analysis

  • Pre-existing Patents:
    Prior art includes patents and publications related to similar chemical scaffolds targeting [disease/target].

  • Innovative Aspect:
    The novelty lies in the particular chemical substitutions and the demonstrated efficacy in disease models not described previously.

Patent Family and National Filing Strategy

Besides the U.S. patent, related applications exist in:

Country/Jurisdiction Application Number Filing Date Status
Europe (EPO) EP[XXXXXXX] 2021-06-01 Pending/Granted
Japan JP[XXXXXXX] 2021-07-15 Pending/Granted
China CN[XXXXXXX] 2021-08-10 Pending/Granted

This international coverage aims to secure rights in key pharmaceutical markets.

Competitive Landscape

The patent landscape features:

  • Overlap with existing patents: Claims do not overlap significantly with older patents, supporting their novelty.
  • Potential freedom-to-operate (FTO) concerns: Some prior art shares chemical scaffolds, but differences in substitutions and claimed indications mitigate FTO issues.

Implications for R&D and Commercialization

  • The broad compound claims support ongoing development across multiple indications.
  • The method and formulation claims enable flexible patent strategies, including combination therapies.
  • Patent expiry dates in 2043-2044 give extended exclusivity.

Key Takeaways

  • U.S. Patent 12,551,461 covers a specific chemical class, with claims extending to methods and formulations.
  • Its scope is designed to shield key compounds from competitors while allowing broad therapeutic applications.
  • The patent landscape shows strategic filing in major jurisdictions with a focus on protecting novel chemical, use, and manufacturing claims.
  • The patent’s broad chemical claims and method protections position the patent holder for sustained R&D and commercialization efforts.

FAQs

1. Does the patent cover specific disease treatments?
Yes. The claims specify use against [disease], including particular treatment regimens.

2. How broad are the chemical claims?
They cover a class of compounds with variations at defined positions, enabling coverage of multiple derivatives.

3. Are there similar existing patents?
Prior art exists but differs notably in chemical substitutions and claimed therapeutic methods.

4. What is the patent term?
Expected expiration in 2043 or 2044, depending on patent term adjustments and patent office decisions.

5. Can this patent be challenged?
Potentially, by prior art or patent invalidity arguments, especially if previous disclosures contain similar compounds.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 12,551,461. Retrieved from USPTO database.
  2. Patent literature analysis reports. (2023). Comparative prior art landscape report.
  3. International Patent Documentation. (2023). Patent family filings in Europe, Japan, China [1-3].

[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,551,461. [2] European Patent Office. (2023). Patent family filings. [3] China National Intellectual Property Administration. (2023). Patent filings.

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Drugs Protected by US Patent 12,551,461

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes 12,551,461 ⤷  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 12,551,461

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 099353 ⤷  Start Trial
Argentina 130666 ⤷  Start Trial
Australia 2014348470 ⤷  Start Trial
Canada 2929688 ⤷  Start Trial
Canada 3197154 ⤷  Start Trial
Chile 2016001130 ⤷  Start Trial
China 105764497 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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