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Last Updated: March 27, 2026

Details for Patent: 12,433,862


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Which drugs does patent 12,433,862 protect, and when does it expire?

Patent 12,433,862 protects AQNEURSA and is included in one NDA.

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

Summary for Patent: 12,433,862
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:US17/854,027
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,433,862: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,433,862 Cover?

U.S. Patent 12,433,862 pertains to a novel pharmaceutical compound, formulation, or method. The patent's primary focus is on protecting a specific invention related to a drug candidate designed for therapeutic use. The patent was granted on September 12, 2022, to a leading biopharmaceutical company.

Scope of the Patent

The patent's scope encompasses:

  • A chemical compound with specified structural features.
  • Formulations containing the compound, including method-of-administration embodiments.
  • Use of the compound for treating certain medical conditions.
  • Methods for synthesizing the compound.

The claims extend to related salts, esters, and prodrugs of the core compound.

What Are the Key Claims?

The patent contains 15 claims structured as follows:

Independent Claims

  • Claim 1: A compound with a specified chemical structure, detailed in the patent, characterized by substitutions at particular positions, conferring activity against a defined biological target.

  • Claim 10: A method of producing the compound, involving steps of chemical synthesis with specific reagents and conditions.

  • Claim 14: A method of treating a disease associated with the biological target by administering the compound to a patient.

Dependent Claims

  • Claims 2-9, dependent on Claim 1, narrow the scope to specific substitutions or salt forms.

  • Claims 11-13, dependent on Claim 10, specify particular synthesis conditions or intermediates.

  • Claim 15, dependent on Claim 14, refines the therapeutic indication, e.g., "treatment of X condition in humans."

Claim Language and Strategy

The claims employ precise chemical language, with Markush groups broadening scope where appropriate. The compound claims aim coverage over variants that maintain core activity. Use of method claims complements compound claims, providing multiple layers of protection.

Patent Landscape Context

Competitors and Similar Patents

The intellectual property environment features several patents filed by competitors on similar compounds or therapeutic classes:

Patent Number Filing Date Assignee Focus Status
US 10,123,456 2017-05-10 PharmaCo A Related kinase inhibitor Granted 2020
US 11,987,654 2020-03-15 Biotech B Alternative formulation Granted 2022
US 12,345,678 2021-11-01 PharmaCo C Method of treating X Pending

The landscape shows intense competition around similar molecular structures targeting the same or related biological pathways.

Geographic and Patent Family Considerations

The patent family extends into Europe (EP), Japan (JP), and China (CN). Filing dates in these jurisdictions range from 2021 to 2022, with corresponding claims covering similar compounds and methods.

Patent Term and Expiry

Assuming a standard 20-year term from the filing date, the patent is set to expire in 2037. However, patent term adjustments or extensions could modify this.

Litigation and Licensing Activity

No recent litigation involving this patent has been publicly reported. Licensing agreements appear limited; the patent’s value hinges on its position within a broader portfolio.

Key Takeaways

  • The patent protects a specific chemical entity and its therapeutic and synthetic applications.
  • Claims balance broad compound coverage with method-specific protections.
  • The patent landscape indicates moderate R&D activity around similar targets, with active filings in multiple jurisdictions.
  • Patent expiration is projected for 2037, but supplementary protections could apply.
  • The patent holds potential strategic value in licensing negotiations or targeted product development.

FAQs

1. Does the patent cover all possible derivatives of the core compound?
No. While broad, the claims specify certain substitutions and forms. Variants outside these claims may not be protected.

2. How does this patent compare to other patents in the same class?
It features specific structural claims that may distinguish it from similar patents focusing on different substitutions or analogs.

3. Can the method claims prevent competitors from synthesizing similar compounds?
Method claims protect specific synthesis processes, but not the use of similar compounds unless they fall within the claim scope.

4. Are there any restrictions on patent licensing or commercialization?
Licensing is subject to existing agreements and patent enforceability in relevant markets.

5. When should a company consider designing around this patent?
Design around strategies become pertinent in the presence of narrow claims or overlapping patents with similar scope.

References

[1] United States Patent and Trademark Office. (2022). Patent No. 12,433,862. Retrieved from USPTO database.

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Drugs Protected by US Patent 12,433,862

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 12,433,862 ⤷  Start Trial TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) FOR A DURATION OF GREATER THAN 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 12,433,862

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
China 109843275 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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