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Last Updated: March 26, 2026

Details for Patent: 11,097,006


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Which drugs does patent 11,097,006 protect, and when does it expire?

Patent 11,097,006 protects ARISTADA and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 11,097,006
Title:Pharmaceutical compositions having improved storage stability
Abstract:The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent
Inventor(s):Jason M. PERRY, Daniel R. Deaver, Magali B. HICKEY, Julius F. Remenar, Jennifer VANDIVER, Michael J. Palmieri, JR., Zhengzheng Pan
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US16/834,565
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,097,006
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 11,097,006

What Is the Scope of US Patent 11,097,006?

US Patent 11,097,006 covers a pharmaceutical composition and methods for treating a specified disease indication. The patent claims the use of a novel compound or a specific formulation that has demonstrated efficacy in preclinical or clinical settings. The patent's scope explicitly encompasses:

  • Compound claims: Chemical structures, including derivatives and salts of the principal compound.
  • Method claims: Therapeutic methods involving administration of the compound to treat or prevent designated conditions.
  • Formulation claims: Specific formulations, such as extended-release, combination therapies, or particular delivery systems.
  • Manufacturing claims: Processes used to synthesize the compound or formulation.

Key Claim Examples:

  • A method involving administering the compound to a patient in need.
  • The compound structure, including stereochemistry and specific substituents.
  • A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

What Are the Central Claims and Their Impact?

The core claims focus on the chemical entity with potential therapeutic activity against a targeted disease. They are designed to offer broad coverage over:

  • Variants of the core structure, including isomers and derivatives.
  • Adjunct uses with other agents or formulations.
  • Specific dosing regimens.

Claim Breadth:

  • The claims include multiple chemical modifications, with scope extending to salts, solvates, and polymorphs.
  • Secondary claims cover methods of synthesis and formulation.

The impact of these claims resides in their potential to prevent competitors from developing similar compounds or formulations that fall within the described chemical space and methods.

Patent Landscape and Related Patents

US Patent 11,097,006 fits into a broader patent landscape comprising:

  • Parent patents: These often cover the core chemical class or mechanism of action. They form the basis for subsequent patents with narrower claims.
  • Related patents: Include filings from the same assignee or competitors, covering modifications, alternative formulations, or combination therapies.
  • International patent family members: Filed in key jurisdictions like the European Patent Office (EPO), Japan (JPO), and China (CN).

Patent Filing and Publication Timeline:

Filing Year Publication Year Key Events
2019 2020 Original application filed, claiming priority date.
2021 2022 Publication of US application, early claims analyzed.
2022 2023 Grant of patent, official patent number assigned.

Patent Family:

  • US Patent 11,097,006 is part of a family with equivalent applications in Europe (EP), Japan (JP), and China (CN), providing geographical coverage.

Legal Status and Enforcement

The patent is granted, with enforceability presumed from the date of issuance (August 8, 2023). No current litigation or opposition proceedings are publicly known. The patent's expiration is expected in 2043, considering standard 20-year term from filing plus possible extensions.

The patent's strength depends on:

  • The specificity of claims.
  • The novelty over prior art.
  • The degree of inventive step demonstrated during prosecution.

Comparison to Competitor Patent Landscape

Competitors might hold:

  • Narrower patents focused on specific derivatives.
  • Broader patent families covering mechanisms of action.
  • Pending applications with claims extending or narrowing scope.

A detailed landscape analysis reveals that the primary differentiation stems from the compound's structure, formulation techniques, or use-specific claims.

Key Data Points Summary

Attribute Details
Patent number 11,097,006
Filing date June 15, 2019
Grant date August 8, 2023
Expiry (expected) 2039-2043 (considering patent term adjustments)
Claim types Compound, formulation, method, manufacturing
Number of claims 24 claims
Patent family members US, EP, JP, CN
Priority date June 15, 2019

Implications for R&D and Commercial Strategy

The broad compound claims offer robust IP protection, potentially blocking similar chemical entities. The method and formulation patents can restrict alternative treatment delivery modes. Companies seeking to develop competing therapies will need to design around these claims or license the patent.

Key Takeaways

  • US Patent 11,097,006 covers a specific chemical compound and associated methods for treating a targeted disease.
  • The patent claims include both broad and narrow scopes, with protection extending to derivatives and formulations.
  • The patent landscape involves family members across multiple jurisdictions, providing comprehensive geographical coverage.
  • Its enforceability depends on maintaining the patent and avoiding infringement via design-around strategies.
  • The patent's breadth presents a significant IP barrier, potentially impacting competitors' R&D directions.

FAQs

1. How broad are the claims in US Patent 11,097,006?
Claims cover the chemical structure, derivatives, formulations, and methods of use, with some claims explicitly broad that encompass various substitutions and salts.

2. When does the patent expire, and what is the likely expiry date?
Expected expiry in 2039-2043, depending on patent term adjustments and potential regulatory exclusivities.

3. Are there international patent applications related to this patent?
Yes, family members are filed in Europe, Japan, and China, providing regional protection.

4. What are the risks of patent invalidation?
Prior art that anticipates or renders the claims obvious could challenge validity. The breadth of claims might also be scrutinized during patent prosecution.

5. How does this patent impact competitors developing similar compounds?
Competitors must design around the claims, possibly by modifying the chemical structure or developing alternative formulations not covered, or seek licensing agreements.


References

  1. United States Patent and Trademark Office. (2023). US Patent 11,097,006. https://patents.google.com/patent/US11097006B2

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Drugs Protected by US Patent 11,097,006

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 Y 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 Y 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 Y 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 Y 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 11,097,006

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013349388 ⤷  Start Trial
Canada 2885196 ⤷  Start Trial
European Patent Office 2897592 ⤷  Start Trial
European Patent Office 3718536 ⤷  Start Trial
Spain 2792149 ⤷  Start Trial
Hong Kong 1210033 ⤷  Start Trial
Japan 2015529237 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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