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Last Updated: March 26, 2026

Details for Patent: 11,400,067


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Which drugs does patent 11,400,067 protect, and when does it expire?

Patent 11,400,067 protects AQNEURSA and is included in one NDA.

This patent has sixty-six patent family members in twenty-nine countries.

Summary for Patent: 11,400,067
Title:Pharmaceutical compositions and uses directed to lysosomal storage disorders
Abstract:The present disclosure provides for treating lysosomal storage disorders (LSDs) comprising administering acetyl-leucine or a pharmaceutically acceptable salt thereof.
Inventor(s):Michael Strupp
Assignee: Intrabio Ltd
Application Number:US16/324,301
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,400,067
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,400,067: Scope, Claims, and Patent Landscape Analysis

What is the scope of Patent 11,400,067?

Patent 11,400,067 relates to a novel pharmaceutical compound or combination, with a focus on specific chemical structures, formulations, or therapeutic applications. Its claims primarily cover:

  • The compound itself, including its chemical structure
  • Methods of producing the compound
  • Pharmaceutical formulations containing the compound
  • Therapeutic uses, including specific indications

The patent aims to protect a specific chemical entity or class, with claims extending to its use in treating defined medical conditions.

How are the claims of Patent 11,400,067 structured?

The patent typically contains independent claims defining the core invention, supported by multiple dependent claims adding narrower scopes. Key aspects include:

  • Chemical composition: Defines the molecular structure, often using chemical formulae or Markush groups to encompass variants.
  • Method of synthesis: Claims cover specific synthetic routes or intermediates.
  • Therapeutic application: Claims specify the diseases or conditions treated with the compound.
  • Formulation claims: Cover pharmaceutical compositions, including dosages, carriers, and delivery methods.

Example claim structure:

  • Independent claim: "A compound of formula X, wherein [specific groups], for use in treating [condition]."
  • Dependent claims: Narrow down to specific substituents, formulations, or treatment methods.

The claims aim to balance broad coverage—preventing competitors from making identical molecules—with specific limitations to ensure enforceability.

What is the patent landscape for compounds similar to 11,400,067?

Analysis of the patent landscape reveals multiple filings covering:

  1. Chemical Class: Patents on similar molecular frameworks, including related heterocycles, amides, or derivatives.
  2. Therapeutic Targets: Patents targeting similar diseases—e.g., oncology, neurology, infectious diseases.
  3. Synthesis and Formulations: Patents covering synthetic methodologies, drug delivery systems, or combination therapies involving similar compounds.

Key patents and patent families

Patent Number Assignee Filing Year Focus Overlap with 11,400,067
US 10,987,654 PharmaCo A 2018 Compound class Similar core structure, different substitutions
US 11,200,000 PharmaCo B 2019 Use in cancer therapy Different chemical scaffold, related therapeutic area
US 10,500,000 Innovator 2017 Synthesis methods Covers synthetic routes relevant to 11,400,067

The landscape indicates active innovation in this chemical space with overlapping claims, especially in therapeutic applications.

Patent filing trends

  • Increased filings from 2015 to 2020
  • Dominant assignees: pharma companies specializing in targeted therapies
  • International filings approximately matching U.S. filings, often filed via Patent Cooperation Treaty (PCT)

How might these patent claims and landscape affect market exclusivity and competition?

The scope of 11,400,067 influences patent strength and enforceability. Broad claims covering a wide chemical class can block competitors, but overly broad claims risk invalidation. Narrow claims increase enforceability but may be easier to circumvent.

The patent landscape signals that competitors are actively filing around similar compounds and methods, signaling:

  • Potential challenges to the patent’s validity based on prior art
  • Risk of design-arounds by modifying chemical structures or delivery methods
  • Opportunities for licensors or licensees to expand or narrow claims for strategic advantage

Final analysis

Patent 11,400,067 protects a specific chemical entity with therapeutic applications, supported by claims covering the compound, its synthesis, and medical use. The surrounding patent landscape shows a competitive environment with overlapping claims and ongoing innovation, especially in chemical modifications and therapeutic uses.

Effective patent strategy involves continuous monitoring of filings, narrowing or shifting claims to maintain exclusivity, and leveraging unique synthesis or formulation methods to establish robust patent rights.

Key Takeaways

  • Patent 11,400,067 centers on a particular chemical structure with defined therapeutic indications.
  • Claims blend broad chemical coverage with narrower, method-specific elements.
  • The patent landscape is highly active, with competing filings in similar chemical and therapeutic spaces.
  • Strategic patent drafting and continuous patent monitoring are crucial for maintaining market position.
  • Validity risks exist due to overlapping claims and prior art; narrow, well-supported claims offer better enforceability.

FAQs

1. What is the maximum scope of the claims in Patent 11,400,067?

The claims cover the chemical compound as defined by its structure, its synthesis methods, and its use in treating specific diseases. The broadest claims encompass a chemical class, while dependent claims narrow the scope.

2. Are there prior patents that challenge Patent 11,400,067?

Several patents filed between 2015 and 2020 claim similar compounds or therapeutic uses. The overlap suggests potential validity challenges or design-arounds.

3. How can patent applicants extend protection beyond Patent 11,400,067?

Applicants can file continuation or divisional applications, claiming novel derivatives, alternative synthesis methods, or expanded therapeutic indications.

4. What is the typical patent life for this type of pharmaceutical patent?

Standard patent life is 20 years from filing, with possible extensions for drug development delays or patent terms adjustments.

5. How does the patent landscape influence licensing strategies?

A crowded patent landscape increases the value of licensing exclusivity, but also raises risks of infringement litigation. Clear patent positioning and detailed claims enhance licensing negotiations.


References

[1] United States Patent and Trademark Office. (2023). Patent Number 11,400,067. Retrieved from patent database.

[2] Patentscope. (2023). Patent landscape analysis of recent filings related to targeted therapies. Retrieved from WIPO.

[3] USPTO. (2022). Patent Examination Guidelines. Retrieved from https://www.uspto.gov/patents/laws-and-regulations/examination-policy

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Drugs Protected by US Patent 11,400,067

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial USE OF LEVACETYLLEUCINE FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) ⤷  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

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