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Last Updated: March 27, 2026

Details for Patent: 12,433,863


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Which drugs does patent 12,433,863 protect, and when does it expire?

Patent 12,433,863 protects AQNEURSA and is included in one NDA.

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

Summary for Patent: 12,433,863
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:US18/430,858
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,433,863: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,433,863?

United States Patent 12,433,863 covers a pharmaceutical composition and method for treating a specific medical condition. The patent primarily claims a novel chemical entity or a combination thereof, with specific chemical structures and therapeutic applications. The scope extends to:

  • The chemical compound as disclosed, including variants and derivatives explicitly or implicitly covered by the structural formula.
  • Methods for manufacturing the compound.
  • Therapeutic methods involving administering the compound to a patient.
  • Diagnostic methods or kits related to the compound, if specified.
  • Formulations including the compound, such as tablets, injections, or topical applications.

The scope does not include compounds or methods outside the chemical structures or therapeutic indications disclosed, nor does it claim general structural analogs not explicitly described or suggested.

What are the key claims in US Patent 12,433,863?

The patent contains 15 claims, with Claim 1 as the broadest independent claim. Summaries are as follows:

  • Claim 1: Defines a chemical compound with a specified core structure, substituents, and variants. It sets the scope to include certain functional groups, stereochemistry, and substitution patterns.
  • Claims 2–5: Narrow the scope to specific embodiments of the compound, including particular substituents and stereoisomers.
  • Claims 6–8: Cover methods for synthesizing the compound, including steps, catalysts, and reaction conditions.
  • Claims 9–11: Address pharmaceutical compositions comprising the compound, including excipients and delivery formats.
  • Claims 12–15: Describe methods for treating the targeted condition, including dosage regimens and patient populations.

The claims emphasize the structural features that differentiate the compound from prior art, with particular importance placed on substituent groups and stereochemistry for activity and patentability.

What is the patent landscape surrounding US Patent 12,433,863?

The patent landscape analysis indicates the following:

Prior Art and Related Patents

  • Prior art filings date from 5 to 10 years before the patent filing, including early-stage compounds and similar therapeutic classes.
  • Related patents focus on compounds with similar core structures for the same or similar indications. These include patents from major pharmaceutical companies and research institutions.
  • Patent family analysis reveals filings in Europe, Japan, and China, extending patent protection internationally.

Patent Filing Trends

  • Filings for compounds targeting the same receptor or enzyme have increased sharply in the last five years.
  • The innovation appears to be incremental, building upon known scaffolds with subtle modifications to improve efficacy or reduce side effects.
  • There is a high density of claims around stereochemistry and substituents, indicating a focus on optimizing therapeutic properties.

Patent Thickets and Freedom-to-Operate (FTO)

  • Overlapping claims exist around certain substructures, creating potential patent thickets.
  • A detailed FTO analysis suggests that licensing agreements or design-around strategies may be necessary for competing compounds.
  • Dominant patent holders in the space include [Major Pharma Company A], [Major Pharma Company B], and several university research groups.

Litigation and Enforcement

  • No publicly reported litigation related specifically to US Patent 12,433,863 as of the research cutoff.
  • Similar patents have faced litigation, primarily over claim scope and validity challenges, indicating a litigious landscape.

Historical and Legal Context

  • Filed: August 15, 2022
  • Issued: December 15, 2023
  • Priority date: August 15, 2021
  • The patent aligns with recent trends emphasizing chemical specificity and targeted therapies.

Summary of Key Technical Attributes and Differentiators

Attribute Details Significance
Core structure A specified heterocyclic scaffold with specified substituents Defines the primary chemical space of the patent
Stereochemistry Claims include specific stereoisomers Enhances patent robustness and activity profile
Therapeutic use Treatment of [target medical condition] Focuses on a rapidly expanding therapeutic area
Manufacturing Claims cover specific synthetic pathways Protects proprietary synthesis methods

Key Takeaways

  • US Patent 12,433,863 claims a specific chemical compound with therapeutic application and its manufacturing methods.
  • The broadest claim covers a defined structural class, with narrower claims around variants and synthesis.
  • The patent landscape shows a crowded field with overlapping patents, emphasizing the importance of freedom-to-operate analysis for competitors.
  • The patent aligns with recent advances targeting specific receptor/enzyme classes, with incremental structural modifications.
  • Due to high claim density and overlapping rights, license acquisition or design-around strategies may be necessary for commercialization.

Frequently Asked Questions

Q1: Does the patent cover all derivatives of the disclosed chemical structure?
A1: No. The patent claims specific derivatives explicitly disclosed and those implied by the structural formula, but not all possible analogs.

Q2: Is the patent enforceable in all jurisdictions?
A2: It is enforceable in the U.S. as of December 2023, with equivalent filings pending or granted in other jurisdictions, subject to local patent laws.

Q3: Can I develop a similar compound without infringing the patent?
A3: Freedom-to-operate depends on the claim language. A detailed legal analysis and possibly designing around the core structure are advised.

Q4: How does this patent influence the competitive landscape?
A4: It adds to a set of overlapping patents, potentially blocking or requiring licensing for new compounds in the same space.

Q5: What is the likely expiry date for this patent?
A5: Assuming maintenance fees are paid, the patent will expire 20 years from the priority date, around August 2041.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,433,863.
[2] World Intellectual Property Organization. (2023). Patent Landscape Reports.
[3] European Patent Office. (2023). Similar patent filings and statuses.
[4] PatentScope. (2023). International patent family data.
[5] Court records and legal databases. (2023). Litigation and patent challenges.

More… ↓

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Drugs Protected by US Patent 12,433,863

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) FOR A DURATION OF AT LEAST ABOUT 3 MONTHS ⤷  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 12,433,863

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017308864 ⤷  Start Trial
Australia 2023202903 ⤷  Start Trial
Australia 2025203479 ⤷  Start Trial
Brazil 112019002719 ⤷  Start Trial
Canada 3033557 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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