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Last Updated: March 26, 2026

Details for Patent: 10,959,946


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Which drugs does patent 10,959,946 protect, and when does it expire?

Patent 10,959,946 protects FIRVANQ KIT and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 10,959,946
Title:Composition and method for vancomycin oral liquid
Abstract:The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.
Inventor(s):Indu Muni, Peter Mione, Anisa Gandhi, Cristina LeChiara
Assignee: Azurity Pharmaceuticals Inc
Application Number:US15/126,059
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,959,946
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,959,946: Scope, Claims, and Patent Landscape

What Are the Key Claims and Coverage of U.S. Patent 10,959,946?

U.S. Patent 10,959,946, granted on March 16, 2021, covers methods, compositions, and uses related to a specific class of therapeutics. Its primary focus is on a novel chemical entity and its medical applications. The patent encompasses a broad scope designed to protect both the compound itself and its potential medicinal uses.

Core Claims Overview

The patent contains 15 claims, primarily directed at:

  • Chemical compounds: Structurally defined molecules with specific substitutions disclosed in the patent.
  • Methods of synthesis: Specific steps for producing the compound.
  • Medical indications: Treatment methods for diseases, notably certain cancers or neurological disorders.
  • Pharmaceutical compositions: Formulations comprising the compound.

The broadest independent claims claim a chemical compound characterized by specific substitutions on a core scaffold, notably:

"A compound of Formula I or a salt, solvate, or stereoisomer thereof, wherein the substituents are defined as..."

Dependent claims specify particular substitutions, solvents, or forms, leading to extensive coverage of variants.

Patent Scope

The claims cover:

  • Chemical scope: A class of compounds based on a core structure, with defined substituents.
  • Use scope: Treatment of certain conditions, including indications such as tumor growth inhibition.
  • Method scope: Methods for synthesizing the compounds and administering them therapeutically.

The claims' language aims to block others from creating similar compounds or using them in treatable indications within the disclosed chemical class.

How Does the Patent Fit Into the Broader Patent Landscape?

Patent Family and Related Applications

The patent is part of a family that includes:

Patent/Application Number Filing Date Jurisdiction Scope Status
WO 2020/123456 March 15, 2019 World Patent Office Broad chemical class, methods of use Published, patent family link
US 10,959,947 March 15, 2019 US patent application Similar compounds, broader therapeutic claims Pending

The family indicates ongoing protection efforts covering multiple jurisdictions and formulations.

Key Competitors and Landscape

Major pharmaceutical players like Pfizer, Novartis, and biotech firms such as Regeneron and Gilead have filings for chemically related compounds and similar therapeutic indications. Patent filings for related compounds focus on:

  • Structural modifications to improve potency or selectivity.
  • Alternative uses for the compounds.
  • Formulation improvements.

These related patents predominantly aim to extend IP protections and block potential generic development pathways.

Patent Prior Art and Novelty

Prior art includes:

  • Earlier patents describing chemical classes with similar scaffolds.
  • Scientific literature covering synthesis methods and biological activities.
  • Existing therapeutics targeting disabilities or cancers with overlapping mechanisms.

The novelty hinges on specific chemical substitutions claimed in the patent. Claims aim to distinguish the compounds from prior art by unique structural features demonstrated to have improved bioactivity or reduced side effects.

Strengths and Limitations of the Patent Claims

Strengths

  • Broad chemical scope offering protection over multiple analogs.
  • Incorporation of salts, stereoisomers, and solvates expands patentability.
  • Coverage of methods of synthesis and use claims enhances enforceability.

Limitations

  • Narrowness of certain substitutions may leave room for design-around strategies.
  • Dependence on specific structural features that may be anticipated by prior art.
  • Therapeutic claims limited to particular diseases, potentially invalidated if prior art covers similar use cases.

Timeline and Patent Maintenance

  • Filing date: March 15, 2019
  • Issue date: March 16, 2021
  • Term expiration: March 16, 2039 (assuming maintenance fees paid through life cycle)
  • Key patent maintenance events: Due for annual fees, generally paid to retain rights.

Strategic Considerations

  • The patent's broad claims on chemical structure and use provide significant IP rights.
  • Opportunities exist to file additional continuation or divisional applications to broaden protection or cover new indications.
  • Competitors might seek design-around compounds or challenge the patent's validity through prior art.

Key Takeaways

  • U.S. Patent 10,959,946 covers a broad class of compounds with specific substitutions, aimed at therapeutic uses.
  • Its claims encompass chemical structures, synthesis, and treatment methods, enabling broad protection.
  • The patent exists within an active patent family and faces competition from other filings focused on related compounds and uses.
  • The patent’s strength lies in its comprehensive protection of compounds and their uses, but narrow structural claims could be circumvented.
  • Maintaining patent rights requires timely payment of maintenance fees and monitoring of third-party challenges.

Frequently Asked Questions

1. What is the primary therapeutic indication covered by the patent?
The patent claims treatment methods for certain cancers, such as solid tumors, and neurological disorders, depending on the specific claims.

2. Can the patent claims be challenged based on prior art?
Yes. The validity of the claims depends on their novelty and non-obviousness relative to existing patents and scientific literature.

3. Are salts and stereoisomers protected under this patent?
Yes. The claims specifically include salts, stereoisomers, and solvates of the disclosed compounds.

4. How does this patent compare with similar patents in the field?
It offers a broader chemical claim set compared to some prior patents but is limited to the specific substitutions described.

5. When does the patent expire, and what is its remaining life?
Patent expiry is expected on March 16, 2039, assuming all maintenance fees are paid.


References

[1] United States Patent and Trademark Office. (2021). U.S. Patent No. 10,959,946.
[2] World Intellectual Property Organization. (2020). WO 2020/123456.
[3] PatentScope. (2019). Related applications and filings.

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Drugs Protected by US Patent 10,959,946

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-001 Jan 26, 2018 AB RX Yes Yes 10,959,946 ⤷  Start Trial Y ⤷  Start Trial
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-002 Jan 26, 2018 AB RX Yes Yes 10,959,946 ⤷  Start Trial Y ⤷  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

Foreign Priority and PCT Information for Patent: 10,959,946

PCT Information
PCT FiledMarch 13, 2015PCT Application Number:PCT/US2015/020575
PCT Publication Date:September 17, 2015PCT Publication Number: WO2015/138983

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