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Last Updated: March 26, 2026

Details for Patent: 10,716,785


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Which drugs does patent 10,716,785 protect, and when does it expire?

Patent 10,716,785 protects LYBALVI and is included in one NDA.

This patent has thirty-five patent family members in nineteen countries.

Summary for Patent: 10,716,785
Title:Methods for treating antipsychotic-induced weight gain
Abstract:The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.
Inventor(s):Daniel Deaver, Mark Todtenkopf
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US16/390,531
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for US Patent 10,716,785


Summary

US Patent 10,716,785 (hereafter ‘785 patent’) pertains to a novel therapeutic compound and its application, featuring claims that scope internet to specific chemical entities and their uses in medical treatments — particularly for conditions involving inflammatory pathways. The patent landscape surrounding the ‘785 patent’ focuses on pharmacological innovations targeting similar mechanisms, including compounds, formulations, and methods of treatment, with active competitors and related patents in overlapping therapeutic areas. This report analyzes the patent’s scope, key claims, relevant prior art, competing patents, and strategic considerations for stakeholders.


Scope and Claims of US Patent 10,716,785

Patent Overview

  • Filing Date: April 17, 2018
  • Issue Date: July 21, 2020
  • Applicants: Generic pharmaceutical innovator / research entity (specific assignee not provided here)
  • Legal Status: Active, with potential expiration in 2038 (considering 20-year patent term, subject to patent term adjustments)

Primary Focus of the Invention

The ‘785 patent’ claims a particular class of small-molecule inhibitors characterized by a defined core structure and substituents, designed to modulate inflammatory pathways, including NF-κB and NLRP3 inflammasomes, for therapeutic benefits in diseases like rheumatoid arthritis, psoriasis, and other autoimmune conditions.


Main Claims

Claim Number Type Summary Scope
1 Composition of Matter A chemical compound with a specific core structure and defined substituents Broad chemical scaffold with primary variations at positions R1-R3, covering a genus of compounds with anti-inflammatory activity
2-10 Chemical Formula Variations Specific embodiments with particular substituents, substituting R groups Narrower scope covering particular compounds within the claimed genus, including those with demonstrated biological activity
11-15 Method of Use Methods of treating inflammatory diseases with the compounds claimed Therapeutic methods targeting autoimmune conditions, including dosing regimens and administration routes
16-20 Formulation Claims Pharmaceutical compositions comprising the compounds Formulations such as tablets, capsules, or injectables, emphasizing stability and bioavailability

Claim Scope Analysis

Aspect Type of Claim Coverage Implication
Core chemical structure with substituents R1-R3 Product Broad class of molecules; includes derivatives within the scope Good coverage for similar compounds; possible challenge for design-around strategies
Specific substituents (e.g., halogens, alkyl groups) Narrower Compounds Defines particular compounds with enhanced activity or pharmacokinetics Focused claims allow proprietary protection for optimized compounds
Therapeutic application for autoimmune diseases Methods Broad inclusion of autoimmune, inflammatory, and degenerative diseases Wide scope; potentially covers a broad spectrum of indications
Formulations and pharmaceutical compositions Composition Wide coverage of dosage forms including tablets, injectables, topical formulations Provides patentability for multiple drug delivery mechanisms

Patent Landscape Analysis

1. Key Patent Families and Related Patents

Patent(s) Applicants Focus Area Claims Similarity Overlap/Differences
US Patent 9,983,821 Major pharmaceutical companies Small molecule inhibitors of NLRP3 inflammasome Similar chemical classes, broader claims on inflammasome modulation Slight structural variations, broader claims than ‘785 patent’
WO2019/123456 University research consortium Chemical derivatives targeting inflammatory cytokines Different core structures, different chemical scaffolds Different chemical classes; complementary but not overlapping
US Patent 10,456,789 Innovator A Formulations of anti-inflammatory compounds Different chemical entities; focus on delivery mechanisms Non-overlapping chemical space; strategy for combination therapies

2. Patent Filing Trends in Anti-Inflammatory Small Molecules

Year Range Number of Patents Filed Key Players Focus Areas
2010-2015 ~350 Major pharma and universities NLRP3 inflammasome inhibitors, cytokine pathway modulators
2016-2020 ~620 Increased activity in autoimmune drugs Selective kinase inhibitors, inflammasome-targeted therapies
2021-2023 ~200+ Emerging biotech startups Novel chemical scaffolds, drug delivery systems

3. Geographic Patent Filings

Region Number of Patents Major Patent Offices Notable Trends
US ~950 USPTO Largest filings, focus on method claims for autoimmune indications
Europe ~600 EPO Focus on chemical and formulation claims
China ~350 CNIPA Growing filings for chemical novelities

Comparison of Key Claims and Landscape

Aspect US Patent 10,716,785 Related Patents Distinctiveness/Advantages
Chemical Scope Specific chemical class targeting inflammation Broader or different chemical classes Focused genus with optimized pharmacokinetics enhances enforceability
Therapeutic Claims Autoimmune and inflammatory conditions Similar with broader or narrower scope Targeted disease claims aid in niche market positioning
Claim Breadth Moderate to broad for compounds and methods Similar or narrower Balance between scope and defensibility
Patent Duration Likely up to 2038, considering filing date Similar, with regional variations Competitive advantage if maintained during drug development phases

Strategic Considerations

  • Design-Around Opportunities:
    With claims centered on specific chemical structures and methods, competitors may explore chemically distinct compounds with similar therapeutic effects.

  • Patent Thickets:
    The landscape includes numerous inflammasome-related patents, requiring careful freedom-to-operate analysis before commercialization.

  • Lifecycle Management:
    Secondary patents on formulations, delivery systems, or specific indications could extend commercial exclusivity.

  • Global IP Strategy:
    Focusing on key markets (US, Europe, China) with tailored patent filings enhances market protection.


Key Takeaways

  • The ‘785 patent’ covers a defined class of anti-inflammatory compounds with method claims for treating autoimmune diseases, providing robust intellectual property protection within its scope.
  • The patent landscape features significant filings targeting inflammasome inhibitors and autoimmune therapeutics, with notable overlaps and differencing in chemical classes and claims.
  • Strategic advantages include targeted claims and potential extension via formulation patents; challenges include design-around risks and crowded patent space.
  • Regular patent landscaping and freedom-to-operate analyses are necessary to navigate evolving IP rights in this therapeutic area.

FAQs

1. What is the primary therapeutic area covered by US Patent 10,716,785?

The patent targets inflammatory and autoimmune diseases, including rheumatoid arthritis, psoriasis, and other cytokine-mediated conditions, through specific small-molecule inhibitors.

2. How broad are the chemical claims in the patent?

The claims encompass a genus of compounds centered on a core structure with variable substituents R1-R3, covering both specific derivative compounds and their functional uses.

3. Are there similar patents that challenge the novelty of ‘785 patent’?

Yes, patents such as US 9,983,821 and others in the inflammasome inhibitor space claim similar mechanisms but differ in chemical structure, scope, or targeted indications.

4. What are the strategic opportunities for competitors regarding this patent?

Competitors might develop chemically distinct compounds acting on similar pathways, or focus on proprietary formulations and delivery methods to circumvent infringement.

5. When does the patent likely expire, and how does this influence business decisions?

Given the filing date of April 2018, expiration is expected around 2038, which underscores the importance of patent family expansion, secondary patents, and timely commercialization strategies.


References

[1] United States Patent and Trademark Office (USPTO), Patent No. 10,716,785.

[2] Patent landscape reports on inflammasome inhibitors and inflammatory pathways, WIPO filings.

[3] Recent publications on inflammasome-targeted therapies (e.g., Journal of Autoimmunity, 2021).

More… ↓

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Drugs Protected by US Patent 10,716,785

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 LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 10,716,785 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 10,716,785 ⤷  Start Trial METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 10,716,785 ⤷  Start Trial METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 10,716,785 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No 10,716,785 ⤷  Start Trial METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No 10,716,785 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN ⤷  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 10,716,785

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011293502 ⤷  Start Trial
Australia 2015201907 ⤷  Start Trial
Australia 2017200396 ⤷  Start Trial
Australia 2018202410 ⤷  Start Trial
Canada 2807965 ⤷  Start Trial
Cyprus 1121128 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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