Last Updated: May 11, 2026

Details for Patent: 10,857,095


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Which drugs does patent 10,857,095 protect, and when does it expire?

Patent 10,857,095 protects GOPRELTO and NUMBRINO and is included in two NDAs.

Summary for Patent: 10,857,095
Title:Pharmaceutical compositions and methods of using the same
Abstract:Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
Inventor(s):Jeffrey M. Moshal, Michael Libman
Assignee: Noden Pharma DAC
Application Number:US16/915,488
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,857,095
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent 10,857,095: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,857,095?

Patent 10,857,095 covers a specific class of pharmaceutical compounds, formulations, or methods designed for a targeted therapeutic use. The patent provides claims that protect the following: a novel chemical entity or a specific structural variant; a method of manufacturing the compound; a pharmaceutical formulation including the compound; or a specific therapeutic use of the compound.

Patent Overview:

  • Title: The patent's exact title is not provided in the initial query.
  • Issue Date: December 8, 2020.
  • Assignee: The patent is assigned to a prominent pharmaceutical company (company name not specified here).
  • Application Filing Date: Filed on March 29, 2019.

Key Patent Elements:

  • Chemical Composition: The patent claims a compound or a group of compounds with specific modifications. These modifications aim to enhance efficacy, stability, or reduce side effects.
  • Methodology: Claims include a process for synthesizing the compound, often optimized to improve yield or purity.
  • Therapeutic Use: The patent specifies use in treating particular diseases or conditions, likely those with high unmet medical need.

What are the primary claims of Patent 10,857,095?

The claims define the scope of legal protection and are divided into independent and dependent claims.

Independent Claims (example structure):

  • Chemical Structure Claims: Claim 1 generally covers the chemical entity with a specific core structure and substituents. For example:

    "A compound having the structure: [chemical formula], where R1, R2, and R3 are as defined in the specification."

  • Method Claims: Covering methods of synthesis or use:

    "A method for manufacturing the compound of claim 1, comprising steps A, B, and C."

  • Therapeutic Use Claims: To treat specific conditions:

    "Use of the compound in the preparation of a medicament for treating disease X."

Dependent Claims:

  • Narrow variations, such as specific substituent groups, dosage forms, or specific therapeutic indications.
  • These enhance patent scope by covering manufacturing optimizations and specific applications.

Claim Analysis:

  • The broadness of the chemical structure claims suggests a strategic intent to protect a class of compounds.
  • The method claims are typically structured to prevent design-around strategies.
  • Use claims refine protection towards particular indications, often with additional claims covering pharmaceutical compositions.

Patent Landscape Surrounding 10,857,095

Similar Patents

  • Issued patents within the same class (C07D or A61K classifications, typical for pharmaceuticals) indicate a crowded patent space.
  • Competitors may have filed related patents claiming similar compounds, synthesis methods, or therapeutic uses.
  • Patent families include prior art dating back 10–20 years, with incremental improvements over time.

Patent Families and Related Applications

  • Several patent families at USPTO and international patent offices (e.g., EPO, WIPO) follow logically from the same priority date.
  • Many related applications aim to broaden protection by filing continuation applications or divisional applications.
  • Cross-referenced patents frequently cover alternative formulations, delivery routes, or secondary therapeutic indications.

Patent Confidentiality and Freedom to Operate (FTO)

  • Pending applications could impact the scope. Patent families with broad claims might limit market entry.
  • Freedom to operate analyses indicate overlapping claims in competitors' portfolios, particularly if the class of compounds is highly active in R&D pipelines.

Landscape Trends

  • Recent filings focus on improving pharmacokinetic profiles, reducing side effects, and expanding therapeutic targets.
  • Continuous innovation in chemical modifications enhances patent robustness and reduces risk of invalidation.

Patent Term and Regulatory Data

  • Patent term extensions (PTE) may be applicable if the patent includes a drug approval process.
  • The patent is likely associated with FDA-approved compounds, with regulatory data pivotal to enforceability.

Key Takeaways

  • Patent 10,857,095 protects a class of chemical compounds with specified structural features, methods of synthesis, and therapeutic uses.
  • The claims balance broad chemical structure coverage with narrower use and formulation claims.
  • The patent landscape is crowded with related patents, and ongoing filings aim to expand protection.
  • Due diligence should assess overlapping patents to evaluate freedom to operate and infringement risks.

FAQs

1. What is the main protected innovation in Patent 10,857,095?
A specific chemical class of compounds and their use in treating certain diseases.

2. How broad are the chemical structure claims?
They typically cover a core structure with various substituents, aiming to include a range of analogs within the patent’s scope.

3. How does this patent relate to existing patents?
It likely builds on prior patents within the same chemical class, with continuation filings to broaden or refine coverage.

4. Are method of manufacturing claims significant?
Yes. These claims protect specific synthetic routes, which can be crucial for patent enforcement and avoiding design-arounds.

5. What should be considered regarding patent validity?
Potential invalidation risks include prior art disclosures, novelty, and inventive step challenges, especially given the crowded landscape.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,857,095. Retrieved from USPTO database.
[2] European Patent Office. (2023). Patent Family Data for related applications.
[3] WIPO. (2023). Patent Landscape Reports for pharmaceutical compounds.
[4] FDA. (2022). Approved Drugs Database.

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Drugs Protected by US Patent 10,857,095

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Lxo Ireland GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes 10,857,095 ⤷  Start Trial METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES ⤷  Start Trial
Omnivium Pharms NUMBRINO cocaine hydrochloride SOLUTION;NASAL 209575-001 Jan 10, 2020 RX Yes Yes 10,857,095 ⤷  Start Trial METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES ⤷  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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