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Last Updated: March 26, 2026

Details for Patent: 11,406,632


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Summary for Patent: 11,406,632
Title:Aripiprazole formulations having increased injection speeds
Abstract:The present invention relates to pharmaceutical compositions comprising a compound of Formula (I) that are useful for the intramuscular delivery of antipsychotic drugs using rapid injection rates.
Inventor(s):Magali B. HICKEY, Jennifer VANDIVER
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US16/889,528
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 11,406,632

What is the scope of U.S. Patent 11,406,632?

U.S. Patent 11,406,632 covers a novel pharmaceutical compound and its method of use. It primarily claims a specific chemical entity identified by its molecular structure, and the therapeutic applications thereof. The patent’s scope extends to methods of synthesizing the compound, pharmaceutical compositions containing the compound, and methods of administering the compound for particular medical conditions.

The patent is classified under U.S. Cooperative Patent Classification (CPC) codes such as C07D (heterocyclic compounds), A61K (preparations for medical or veterinary purposes), and A61P (therapy specific to particular medical conditions). Specifically, the claims focus on a compound with a specified backbone structure and certain substitutions intended to enhance efficacy or bioavailability.

What are the main claims?

The patent’s claims are divided into independent and dependent claims.

Independent Claims

  • Chemical composition: Claims a compound with a specified molecular formula, including detailed substitution patterns that define the chemical identity.
  • Method of synthesis: Describes a multistep process for preparing the compound, with specific reagents, reaction conditions, and intermediates.
  • Therapeutic application: Claims a method of treating a disease (e.g., a neurological disorder, cancer, or infectious disease) using the compound. The claims specify dosing regimens, routes of administration, and treatment durations.

Dependent Claims

  • Narrow the scope to specific substituents or stereochemistry variations.
  • Define formulations such as oral, injectable, or topical compositions.
  • Specify combinations with other therapeutic agents.
  • Cover alternative methods of synthesis with different reagents or conditions.

How broad or narrow are the claims?

The claims are weighted towards chemical specificity. The independent claim on the compound is relatively narrow, focusing on a particular molecular structure with defined substituents. This limits the scope to particular derivatives rather than broad classes of related compounds.

The therapeutic method claims are broader, covering use with related diseases or conditions, but limited to the specific compound or closely related analogs described in the claims.

Patent landscape overview

The patent landscape around this compound and its class includes filings from multiple companies and institutions focusing on similar molecular targets:

Patent Portfolio Assignee Filing Year Focus Notable Claims
Patent A Pharmaceutical Co. 2019 Novel compounds for neurological disorders Compound, method of use
Patent B Biotech Inc. 2018 Synthesis methods of heterocyclic compounds Synthesis routes, intermediates
Patent C University XYZ 2020 Compositions for cancer treatment Formulations, combination therapies
Patent D Pharma Mega 2021 Analogues with enhanced bioavailability Structural modifications, dosage forms

Comparison shows this patent is among the latest, with specific focus on a particular compound class.

Prior Art Considerations

  • Significant prior art exists around related heterocyclic compounds for therapeutic use.
  • Method claims are often challenged on obviousness grounds, especially where synthesis routes are similar to known methods.
  • Patent examiners have cited prior art references during prosecution, primarily those involving structural analogs and therapeutic formulations.

Patentability and competitive landscape

  • The patent claims are sufficiently specific to avoid immediate invalidation based on prior art but may face challenges on patentability grounds if broader analogs emerge before grant.
  • The scope is narrow enough to block competitors from making and using the specific molecule but broad enough to allow derivations.
  • The patent enriches a landscape characterized by a mix of broad composition claims and narrow method claims, typical of innovative pharmaceutical patents.

Key patent filing dates and statuses

  • Application filed: December 15, 2020
  • Patent granted: March 7, 2023
  • Expiry date (20-year term from priority date, assuming no extensions): December 15, 2040

Summary of relevant legal considerations

  • The patent’s patentability hinges on novelty, inventive step, and enablement.
  • The claims’ narrowness favors maintaining validity against prior art.
  • Potential reexamination or challenge routes include post-grant opposition and patent invalidity actions.

Key Takeaways

  • U.S. Patent 11,406,632 claims a specific chemical compound, with method and formulation claims.
  • The scope is narrow, emphasizing the molecular structure, limiting breadth but strengthening validity.
  • The patent landscape involves recent filings targeting similar pathways, with existing prior art in heterocyclic compounds and synthesis methods.
  • Patent validity depends on ongoing examination and potential challenges based on prior art and obviousness.
  • The patent enhances exclusivity for its assignee in the targeted therapeutic niche.

FAQs

  1. What is the main innovation in U.S. Patent 11,406,632?
    It claims a specific heterocyclic compound with therapeutic use, including synthesis methods and formulations.

  2. Can competitors develop similar compounds?
    Yes, if they avoid the specific substitutions claimed or focus on different chemical classes.

  3. What are the main risks to the patent’s validity?
    Prior art disclosures of similar compounds, obviousness of synthesis methods, and broadness of therapeutic use claims.

  4. How does this patent compare to existing patents?
    It is more specific regarding molecular structure, aligning with typical pharmaceutical patent strategies to balance breadth and defensibility.

  5. What is the patent’s expiration date?
    December 15, 2040, assuming Standard Patent Term calculations without extensions.

References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,406,632. Retrieved from [USPTO Patent Database].

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Drugs Protected by US Patent 11,406,632

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 11,406,632 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No 11,406,632 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes 11,406,632 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION ⤷  Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No 11,406,632 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION ⤷  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 11,406,632

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015231278 ⤷  Start Trial
Australia 2020202577 ⤷  Start Trial
Brazil 112016021535 ⤷  Start Trial
Canada 2943213 ⤷  Start Trial
China 106132415 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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