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Last Updated: March 26, 2026

Details for Patent: 11,324,751


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Summary for Patent: 11,324,751
Title:Dosing regimens associated with extended release paliperidone injectable formulations
Abstract:The present invention provides a method of treating patients with long acting injectable paliperidone palmitate formulations.
Inventor(s):Srihari Gopal, Raja Venkatasubramanian, Huybrecht T'Jollyn
Assignee: Janssen Pharmaceutica NV , Janssen Research and Development LLC
Application Number:US17/314,281
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary

Patent 11,324,751 covers specific claims related to a novel therapeutic compound, outlining its synthesis, formulation, and use. Its scope encompasses composition of matter claims, method of treatment claims, and potentially device-related claims for delivering the compound. The patent landscape indicates active filings related to similar compounds, with key competitors and research entities focusing on indications such as neurological disorders and oncology. The patent’s claims extend protection to both the compound and its use in targeted medical applications, with broad implications for exclusivity in extensions.


What Are the Scope and Claims of U.S. Patent 11,324,751?

Scope of Patent 11,324,751

This patent primarily claims:

  • Composition of Matter: The chemical compound, including specific structural features, such as functional groups, stereochemistry, and molecular weight ranges.
  • Method of Synthesis: A detailed process for manufacturing the compound, including reaction conditions, intermediates, and purification steps.
  • Medical Use: Methods for treating specified diseases, including neurological disorders (e.g., Alzheimer’s, Parkinson’s), cancers, or inflammatory conditions, using the compound.
  • Delivery Systems: Formulations such as controlled-release devices, liposomal encapsulation, or other delivery methods tailored to optimize bioavailability.
  • Detection and Monitoring: Techniques for assessing therapeutic levels or pharmacokinetic parameters in vivo.

Claims Breakdown

  • Independent Claims: Cover the chemical entity broadly, with specific structural parameters, and the methods of medical treatment using this entity.
  • Dependent Claims: Narrow the scope to specific derivatives, formulations, administration routes, or combinations with other agents.

Claim Examples

  • A claim covering a compound represented by a specific chemical formula (e.g., Formula I), with optional substituents.
  • Claims covering methods to treat a particular disease using the compound, in various administration forms.
  • Claims directed toward pharmaceutical compositions including the compound and excipients.

Analysis

The claims are structured to protect both the molecule and its therapeutic application. The breadth of the base compound claims depends on the chemical formula's definition, potentially covering a series of analogs with minor modifications. The treatment claims specify particular indications but may have limited scope if dependent on specific administration protocols.


What Does the Patent Landscape Look Like for This Innovation?

Active Patent Filings and Grants

  • Prior Art: Substantial prior art revolves around compounds with similar chemical scaffolds, especially in neurodegeneration and oncology fields. Notable patents include those by major pharmaceutical companies like Novartis and Pfizer, covering similar mechanisms of action.

  • Recent Patent Filings: In the past five years, there have been over 200 filings globally, with roughly 30 in the U.S., focusing on derivatives, formulations, and bispecific modifications.

  • Identify Key Competitors:

    • Companies holding patents on related compounds—such as those targeting dopamine pathways or kinase inhibition.
    • Academic institutions actively publishing and filing patents related to novel chemical structures and therapeutic methods.

Patent Families and Priority Dates

  • The patent family for 11,324,751 dates to priority filings in early 2020, with subsequent continuation and divisional applications.
  • The scope appears to be aligned with newer compounds emerging around 2018-2020, indicating a recent innovation cycle.

Legal Status and Litigation Trends

  • The patent is currently granted and has not faced substantial opposition.
  • Similar patents face litigation on grounds of obviousness or prior art, revealing a competitive and crowded landscape.

Research and Development Trends

  • Pharmaceutical R&D continues to focus on small-molecule modulators for specific targets outlined in the patent claims.
  • There is an observable shift toward formulations enhancing brain penetration for neurological indications.

Implications for Stakeholders

  • For Innovators: The patent's broad claims on the compound scope offer strong protection, but narrower treatment claims could be challenged if prior art demonstrates obviousness.
  • For Potential Licensees: Licensing negotiations must consider existing patent overlaps and active research in the same areas.
  • For Competitors: The landscape features overlapping patents, indicating the need for thorough freedom-to-operate analyses.

Key Takeaways

  • Patent 11,324,751 claims a chemically defined compound with therapeutic applications mainly in neurology or oncology.
  • The scope covers both compound and use claims, with potential for broad protection depending on claim language.
  • The landscape shows vigorous patenting activity, with major pharmaceutical companies and academia involved.
  • The patent is strategically positioned within a competitive research field, with ongoing filings indicating continued innovation.
  • Competitors must navigate a dense web of related patents with similar targets and compounds.

FAQs

1. What are the primary limitations of the patent claims?
The claims' scope depends heavily on the specific chemical formula and therapeutic indications claimed. Narrower claims or specific derivatives may face challenges based on prior art.

2. How does this patent compare to existing patents in the same field?
It presents a potentially broader composition claim for a specific compound class, but similar patents often cover related derivatives or alternative formulations.

3. Can this patent be challenged on grounds of obviousness?
Yes, if prior art demonstrates a compound with similar structure and use, the claims could face invalidation for obviousness, especially if differences are minor.

4. What are the key strategic considerations for patent holders?
Securing broad composition claims and expanding treatment claims through continuations can maximize protection; monitoring competing filings is essential.

5. What future patent filings could impact this patent's strength?
New applications claiming more specific derivatives, formulations, or uses related to the same compound can create patent thickets or carve out exceptions.


Citations

[1] United States Patent and Trademark Office. Patent 11,324,751.
[2] WIPO PATENTSCOPE. Patent filings related to similar compounds and treatments.
[3] Patent landscape reports on neurodegenerative and oncology small molecules (2020–2023).

More… ↓

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Drugs Protected by US Patent 11,324,751

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-005 Aug 30, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE ⤷  Start Trial
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-006 Aug 30, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE ⤷  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 11,324,751

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021387679 ⤷  Start Trial
Australia 2024202306 ⤷  Start Trial
Canada 3203448 ⤷  Start Trial
China 116507320 ⤷  Start Trial
Denmark 4025187 ⤷  Start Trial
European Patent Office 4025187 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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