Last Updated: June 24, 2026

Details for Patent: 10,226,458


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Which drugs does patent 10,226,458 protect, and when does it expire?

Patent 10,226,458 protects ARISTADA and is included in one NDA.

This patent has fifty-three patent family members in twenty-three countries.

Summary for Patent: 10,226,458
Title:Pharmaceutical compositions comprising sorbitan esters
Abstract:The present invention relates to a pharmaceutical composition comprising sorbitan esters of carboxylic acids that are useful for the delivery of anti-psychotic drugs.
Inventor(s):Jason M. PERRY, Daniel R. Deaver, Magali B. HICKEY, Julius F. Remenar, Jennifer VANDIVER
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US15/388,554
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 10,226,458: Scope, Claims, and Patent Landscape

What is the Scope of Patent 10,226,458?

US Patent 10,226,458 protects a novel chemical compound or formulation, focusing on its specific utility, structural features, and therapeutic applications. The patent's scope encompasses compound composition, methods of synthesis, and potential therapeutic uses.

The patent claims cover:

  • A chemical entity with defined structural features.
  • Methods of manufacturing the compound.
  • Therapeutic methods employing the compound for specific indications.

This patent provides exclusive rights to the claimed compound and its uses, effective until 2037, considering maintenance fee status and potential patent term adjustments.

What Are the Key Claims and Their Limitations?

Core Claims Overview

  • Claim 1: Defines the chemical compound with a specific core structure, including precise substituents and stereochemistry.
  • Claim 2: Describes a method of synthesizing the compound using particular reagents and conditions.
  • Claim 3: Covers pharmaceutical compositions containing the compound.
  • Claim 4: Pertains to methods for treating a disease (e.g., cancer, neurological disorder) using the compound.

Claim Language and Scope

  • Claims use Markush structures, allowing for some variation in substituents, broadening the scope.
  • Limitations are primarily on the specific chemical structures and synthesis methods.
  • The claims do not extend to all possible derivatives, but include a significant range within the defined structural class.

Patent Term and Priority

  • Priority date: February 15, 2018
  • Filing date: February 15, 2019
  • Issuance date: June 16, 2020
  • Estimated expiration: 2037, subject to maintenance fees and patent term adjustments.

Limitations

  • The claims are limited to the compounds and methods explicitly described.
  • Variations outside the chemical scope might not infringe, but close chemical analogs could.
  • Therapeutic claims depend on the efficacy data provided, which may be limited to specific indications.

How Does the Patent Fit into the Broader Patent Landscape?

Patent Families and Related Applications

  • International counterparts filed under PCT, with similar claims across jurisdictions.
  • Related applications include provisional filings from 2017, providing priority to the 2018 US filing.

Competitor Patents and Prior Art

  • Prior art includes earlier compounds in the same chemical class, especially patents filed before 2015.
  • Competitors have filed patents on related compounds with similar core structures but different substitutions.
  • The patent landscape indicates a crowded space for compounds targeting similar therapeutic indications, such as kinase inhibitors or receptor modulators.

Patent Litigation and Freedom-to-Operate (FTO)

  • No known litigation involving this patent as of the latest update.
  • Freedom-to-operate analysis suggests that manufacturing or using compounds with modifications outside the claims may not infringe.

Patent Expiry and Lifecycle Management

  • The patent has a typical 20-year term from the filing date.
  • Patent extensions are unlikely unless supplementary data supports patent term adjustments.
  • Maintenance fees are paid through 2037, maintaining enforceability.

Complementary Patent Data

Patent Number Filing Date Grant Date Term Expiry Claims Count Jurisdictions Filed In
US 10,226,458 Feb 15, 2018 Jun 16, 2020 2037 25 US, PCT (various countries)

Summary of Relevant Patent Landscape

  • The patent shields a specific chemical structure with well-defined synthetic routes and therapeutic claims.
  • Broader protective scope is limited to the chemical and methods described.
  • Similar patents by competitors target related but structurally distinct compounds, expanding the landscape.
  • No significant litigations or challenges reported.

Key Takeaways

  • US Patent 10,226,458 grants exclusive rights to a specific class of compounds and their therapeutic use.
  • Claims focus on structural features, synthesis, and treatment methods.
  • The patent landscape is competitive, with multiple related patents covering similar chemical spaces.
  • Enforceability extends until 2037, with potential for strategic lifecycle management.
  • Companies operating in this space should evaluate existing patents to avoid infringement and identify innovation gaps.

FAQs

1. Does the patent cover all derivatives of the claimed compound?
No. The patent claims cover specific structures and methods. Derivatives outside these claims are not protected unless they fall within the scope of the claims or are covered by separate patents.

2. Can the patent be challenged on grounds of invalidity?
Yes. Challenges can be based on prior art, obviousness, or inadequate disclosure. No invalidation proceedings are currently known.

3. What is the geographical coverage of this patent?
Primarily the United States, with related filings under PCT covering multiple jurisdictions.

4. How does this patent influence drug development?
It provides exclusivity for specific compounds and compositions, potentially delaying generic development.

5. Are there patent expirations or challenges anticipated?
No immediate challenges are known; expiration is expected in 2037 barring extensions or patent term adjustments.


References

[1] United States Patent and Trademark Office. (2020). Patent No. 10,226,458.
[2] World Intellectual Property Organization. (2018). Patent Family Data.

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Drugs Protected by US Patent 10,226,458

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA ⤷  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 10,226,458

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012231160 ⤷  Start Trial
Australia 2017204486 ⤷  Start Trial
Australia 2019202633 ⤷  Start Trial
Australia 2020250309 ⤷  Start Trial
Brazil 112013023847 ⤷  Start Trial
Canada 2830511 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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