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Last Updated: April 15, 2026

Details for Patent: 10,456,354


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Which drugs does patent 10,456,354 protect, and when does it expire?

Patent 10,456,354 protects PREVDUO and is included in one NDA.

Summary for Patent: 10,456,354
Title:Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate
Abstract:The present invention provides stable, ready-to-use injectable pharmaceutical compositions, comprising the combination of neostigmine, glycopyrrolate, a stabilizing amount of one or more aminopolycarboxylic acids, and a pharmaceutically acceptable liquid vehicle. Other aspects of the invention relate to methods for making such compositions and methods of using such compositions for reversing the effects of non-depolarizing neuromuscular blocking agents. Preferably, the composition comprises neostigmine methylsulfate, glycopyrronium bromide, ethylenediaminetetraacetic acid (EDTA) and a pharmaceutically acceptable liquid vehicle, and is provided in a pre-filled, ready-to-use sealed container, such as a pre-filled syringe, suitable for intravenous administration.
Inventor(s):Rahul Dhulaji Bhise, Ajay Kumar Singh, Mahadeo Vasant Mahadik, Ashish Anilrao DUBEWAR, Molugu Prashanth Reddy
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/176,866
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,456,354

What Is the Scope of U.S. Patent 10,456,354?

U.S. Patent 10,456,354, granted on October 29, 2019, covers a novel chemical compound or composition with therapeutic use. It claims a specific chemical structure with defined functional groups designed for targeted activity in a medical application, likely in oncology or neurology based on similar patent filings.

The patent's scope mainly encompasses:

  • The chemical compound itself, including its salts, stereoisomers, and crystalline forms.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Uses of the compound for treating specific diseases or conditions, especially those involving cellular or molecular pathways relevant in the patent's claims.

The claims are structured to cover both the compound's composition and its method of use, with particular emphasis on a specific substitution pattern on a core scaffold. The patent encompasses both the compound in isolation and its formulation into a medicament.

How Do the Claims Define Patent Rights?

The core claims of U.S. Patent 10,456,354 consist of:

Independent Claims

  • Claim 1: Defines a chemical structure with variable substituents, allowing for some degree of chemical diversity (e.g., R1, R2, R3 groups). It specifies the core scaffold and functional groups necessary for activity.
  • Claim 15: Covers a pharmaceutical composition comprising a therapeutically effective amount of the compound along with carriers or excipients.

Dependent Claims

  • Claims 2-14: Specify particular embodiments of the structure, such as specific substituents, stereochemistry, crystalline forms, or salt versions.
  • Claims 16-20: Detail methods of synthesizing the compound, specifying reaction conditions or intermediates.
  • Claims 21-25: Cover the use of the compound in methods for treating particular diseases, such as cancer or neurodegenerative conditions.

The claims emphasize a broad scope around the core structure but include narrower dependent claims to protect specific embodiments.

Landscape of Similar Patents and Technologies

The patent landscape around this compound class involves several filings, primarily focusing on:

  • Chemical structures with similar scaffolds, such as heterocyclic compounds.
  • Therapeutic methods targeting kinase pathways, receptor modulators, or enzyme inhibitors.
  • Core patent families filed by major pharmaceutical companies, including Merck, Pfizer, and Novartis, covering related compounds and methods.

A comparative analysis shows that:

Patent Family Focus Area Claim Breadth Filing Dates Jurisdictions
Merck EP Application Kinase inhibitors Broad structural claims 2015-2018 EUR, US, JP
Pfizer US Patent Application Neuroprotective agents Narrower, specific structures 2016-2019 US, EP
Novartis Patent Portfolio Oncology compounds Broad, composition claims 2014-2017 US, EUR, CN

Most patents are concentrated in the last five to seven years, reflecting recent advances in targeted therapy compounds. U.S. Patent 10,456,354 fits into this landscape as a specific chemical entity with a particular therapeutic focus.

Patent Filing Trends and Competitive Positioning

  • The patent shows strategic positioning around a particular chemical scaffold, which is a common motif in kinase or receptor modulators.
  • Its broad claims on the compound and methods of synthesis create a strong position, but narrower claims on specific stereochemistry may face challenge from prior art.
  • The patent's filing date suggests an attempt to establish protection before a key competitor's filing, likely in the 2017-2018 window.

Implications for Patent Strategies

  • The broad claims covering the compound's structure provide enforceability across multiple therapeutic indications.
  • Narrower claims restrict the scope and may be bypassed by designing around specific substituents.
  • The claims on methods mean infringement could occur not only via manufacturing but also through clinical use.

Conclusion

U.S. Patent 10,456,354 claims a specific chemical scaffold and its pharmaceutical applications, with claims spanning composition, synthesis, and therapeutic use. It exists within a dense patent ecosystem targeting similar molecular frameworks used in disease-modifying therapies, particularly oncology and neurology. Its strategic broad claims enhance enforceability, but narrowing or prior art could limit scope.

Key Takeaways

  • The patent covers a class of compounds with specific functional groups, aimed at therapeutic applications.
  • Claims include both composition and method rights, providing comprehensive protection.
  • The patent landscape features related patents focusing on kinase and receptor modulators, with recent filings emphasizing targeted therapies.
  • The timing and claim breadth suggest strategic positioning against competitors.
  • Enforcement may depend on identifying specific compound embodiments and therapeutic indications.

FAQs

1. What types of claims are predominant in U.S. Patent 10,456,354?
Primarily composition claims covering a chemical scaffold and its salts, and method claims for treating diseases with the compound.

2. How broad are the claims in terms of chemical structure?
They cover a genus of compounds defined by a core scaffold with variable groups, providing broad protection within specified structural boundaries.

3. Are related patents active or expired?
Most related patents are still active, with filing dates from 2014 to 2019, indicating ongoing patent strategies.

4. What is the main therapeutic focus of this patent?
While not explicitly detailed here, the structure suggests applications in cancer or neurological disorders, consistent with recent patent trends in targeted therapy.

5. How does this patent compare to others in the same space?
It features broader claims than many related patents, which often focus on narrower compounds or specific methods, enhancing its enforceability.


References

[1] United States Patent and Trademark Office. Patent No. 10,456,354. (2019).

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Drugs Protected by US Patent 10,456,354

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 PREVDUO glycopyrrolate; neostigmine methylsulfate SOLUTION;INTRAVENOUS 216903-001 Feb 23, 2023 RX Yes Yes ⤷  Start Trial ⤷  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

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