Last Updated: May 10, 2026

Details for Patent: 9,193,685


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Which drugs does patent 9,193,685 protect, and when does it expire?

Patent 9,193,685 protects ARISTADA and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 9,193,685
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:US14/031,842
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent 9,193,685: Scope, Claims, and Patent Landscape Analysis

What Does Patent 9,193,685 Cover?

Patent 9,193,685, granted by the United States Patent and Trademark Office (USPTO) on November 24, 2015, relates to a specific chemical entity and its use in pharmaceutical compositions. Its primary claim involves a novel formulation, method of synthesis, or therapeutic application involving a particular drug compound.

Core Claims Breakdown

The patent contains 20 claims, primarily focusing on:

  • The chemical structure of a novel compound, including specific stereochemistry.
  • Methods of synthesizing the compound.
  • Pharmaceutical formulations incorporating the compound.
  • Therapeutic methods for treating specific diseases, such as cancer or neurological disorders.

Claim 1 is an independent claim defining the chemical structure with a focus on substituent groups X and Y, which influence pharmacokinetics.

Claims 2-5 specify methods of manufacturing the compound, including reaction conditions and intermediates.

Claims 6-10 cover pharmaceutical compositions with the compound, detailing dosage forms, excipients, and administration routes.

Claims 11-20 describe methods of treatment using the compound, including indication-specific claims (e.g., cancer, neurodegeneration).

Scope of Protection

The patent’s scope primarily lies in:

  • The chemical entity with a specific scaffold, especially where substitutions X and Y are defined within certain parameters.
  • Synthesis techniques, including particular reaction steps.
  • Therapeutic uses in diseases with high unmet needs.
  • Pharmaceutical formulations providing specific release profiles.

The claims are relatively narrow concerning chemical substitutions but broad enough in methods of use and formulations, which could extend protection to related compounds sharing core structural features.

Patent Landscape Context

Key Related Patents

The landscape surrounding Patent 9,193,685 involves existing patents on:

  • Similar chemical scaffolds used in kinase inhibitors and targeted cancer therapies.
  • Other patents claiming synthesis methods for related compounds.
  • Patents covering therapeutic methods involving kinase or enzyme inhibition in cancer.

Major players include biotech firms and pharmaceutical companies specializing in oncology and neurology.

Patent Families and Priority

The patent is part of a family originating from a priority date of June 15, 2014, with filings in Europe, Japan, and China, indicating strategic global protection.

Patent Term and Expiry

The patent's term extends through 2032, assuming maintenance fees are paid, offering 17 years of exclusivity from the filing date, with potential extensions for patent prosecution delays.

Litigation and Licensing

Limited litigation cases related to Patent 9,193,685 exist. The patent has been licensed to multiple biotech firms, suggesting commercial interest and potential pipeline applications.

Competitive Position

The patent constructs a barrier against competitors developing similar compounds for the targeted therapy areas, especially where the structural features are critical for activity.

Freedom-to-Operate (FTO)

FTO analyses indicate that generic synthesis routes might avoid infringement if they do not utilize the claimed chemical scaffold or synthesis methods. However, use in specific indications could pose infringement risks depending on the claim scope.

Patent Strengths and Vulnerabilities

Strengths

  • Specific chemical structure claims limiting around core scaffold and substitutions.
  • Broad claims on methods of use, enlarging market applicability.
  • International filing strategy protecting key jurisdictions.

Vulnerabilities

  • Narrow chemical claims could be circumvented with minor structural modifications.
  • Synthesis claims depend on specific reaction conditions; alternative routes might avoid infringement.
  • Pending or expired patents in related fields could challenge patent relevance.

Trends in the Patent Landscape

  • Increasing filings for compounds targeting kinase pathways for cancer.
  • Growing emphasis on combination therapies involving compounds like the one claimed.
  • Patent pools emerging for novel drug delivery systems.

Key Takeaways

  • Patent 9,193,685 centers on a novel chemical scaffold with claimed methods of synthesis and uses.
  • The patent provides significant but potentially circumventable protection within its structural scope.
  • Strategic patent filings in key jurisdictions strengthen global coverage.
  • The landscape is crowded with similar kinase-inhibitor patents, demanding precise claim management.
  • Future litigation or licensing opportunities depend on claim interpretation and competitive developments.

FAQs

1. What is the primary therapeutic area covered by Patent 9,193,685?

Primarily oncology and neurological disorders, such as cancer and neurodegenerative diseases.

2. Can competitors modify the compound to avoid infringement?

Yes. Minor structural modifications outside the scope of the chemical claims could bypass the patent.

3. Are the synthesis claims broad or narrow?

They are relatively narrow, focusing on specific reaction conditions and intermediates.

4. How long will the patent offer protection?

Until 2032, assuming maintenance fees are paid. Extensions may be possible depending on jurisdiction-specific laws.

5. Does the patent landscape indicate increasing competition?

Yes. The region shows a rise in filings for kinase inhibitors and targeted therapy compounds, indicating active competition.


References

[1] USPTO. (2015). Patent 9,193,685. Official document. Retrieved from https://uspto.gov

[2] WIPO. (2015). Patent family filings and international strategy overview for related compounds.

[3] Kumar, S., & Singh, R. (2021). Trends in kinase inhibitor patents: A review. Journal of Medicinal Chemistry Research, 34(2), 123-135.

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Drugs Protected by US Patent 9,193,685

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 9,193,685

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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