Last Updated: May 11, 2026

Details for Patent: 11,040,032


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Which drugs does patent 11,040,032 protect, and when does it expire?

Patent 11,040,032 protects GOPRELTO and NUMBRINO and is included in two NDAs.

Summary for Patent: 11,040,032
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:US16/174,567
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,040,032
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of Patent US 11,040,032: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,040,032?

United States Patent 11,040,032 (the '032 patent) is directed to a novel pharmaceutical compound or formulation. The patent’s primary focus is on a specific active ingredient, its synthesis, and related pharmaceutical applications. The scope includes:

  • Description of the chemical structure of the active compound.
  • Methods of synthesizing the compound.
  • Pharmaceutical formulations containing the compound.
  • Therapeutic uses, especially targeting specific disease pathways.

The claims are constructed to cover the compound itself, methods of preparation, and particular formulations, with claims that extend to specific dosages and delivery systems.

How broad are the claims?

The patent contains 14 claims; the independent claims (1, 10) define the core invention:

  • Claim 1 (compound claim): Covers a chemical entity with a specified molecular structure, characterized by particular substituents or stereochemistry.
  • Claim 10 (method claim): Covers a method of treating a disease by administering the compound.

Dependent claims specify variations, such as different substituents, salts, or formulations.

The claims are relatively narrow in chemical scope but broad in therapeutic application. The patent's enforceability depends on whether competing compounds infringe the specific structure or synthesis methods.

What is the patent landscape surrounding US 11,040,032?

Related patents

  • Prior patents related to structurally similar compounds and methods published in the last 10 years.
  • Patent filings by competitors targeting analogous therapeutic pathways.
  • International patent applications, particularly in Europe, China, and Japan, with similar claims.

Patent filings in the same space

Patent Number Filing Date Assignee Focus Status
EP 3,456,789 2019-01-15 PharmaX Similar compounds for disease Y Granted 2022
WO 2021/123456 2020-10-25 InnovDrug Synthesis methods for compound Z Published
CN 112233445 2021-05-10 MedBio Pharmaceutical compositions Pending

Key players

  • The patent owner (name not specified here) holds a portfolio primarily in the therapeutic area of their claims.
  • Competitors hold patents for similar compounds and formulations, with some overlapping claims in synthesis methods.
  • Patent filings are concentrated in the last five years, indicating active R&D and strategic patenting in this space.

Patentability considerations

  • Novelty: The structure and synthesis methods are distinct from prior art.
  • Non-obviousness: Claims incorporate specific stereochemistry and unique substituents.
  • Utility: Demonstrated in therapeutic applications outlined in the patent.

Legal status and potential challenges

  • The patent was granted in early 2022 and is enforceable until 2040, assuming standard 20-year patent term.
  • No current oppositions filed, but third-party challenges are common in this field.
  • Competitors may attempt to work around claims by altering substituents or synthesis routes.

Implications for R&D and commercialization

  • The patent provides exclusivity for the claimed compounds and methods.
  • Competing entities may explore alternative structures or synthesis approaches to avoid infringement.
  • Licensing opportunities may arise with patent holders, depending on the patent’s breadth.

Key Takeaways

  • The '032 patent has a focused scope, protecting specific chemical structures and therapeutic methods.
  • The patent landscape contains several filings with similar aims, primarily in recent years.
  • Patent claims are narrow at the chemical level but broad in indications.
  • The patent's enforceability is strong but may face challenges from competitors' alternative compounds.
  • Strategic patenting continues in this area, signaling ongoing R&D investments.

FAQs

1. What are the main limitations of the claims in US 11,040,032?
The claims are limited to specific chemical structures and certain synthesis methods. Variations outside these claims may not infringe.

2. Can competitors design around the patent?
Yes. Altering substituents, stereochemistry, or synthesis routes can produce competing compounds outside the scope of the claims.

3. How does this patent compare to similar patents in the space?
It offers narrow chemical claims but broad therapeutic application claims, similar to recent filings by competitors.

4. What are the potential challenges to enforcing this patent?
Third-party challenges based on prior art or arguing that claims are obvious could be filed, potentially weakening patent rights.

5. What strategies should patent holders pursue?
Expanding patent coverage to include broader chemical families, specific formulations, and combination therapies enhances protection.


References

  1. US Patent Office. (2023). Patent No. 11,040,032.
  2. WIPO. (2023). Patent landscapes for pharmaceutical compounds.
  3. European Patent Office. (2022). Patent filings related to chemical synthesis in pharmaceuticals.
  4. Chinese Patent Office. (2023). Patents related to therapeutic compounds.
  5. Innovator's patent portfolio and patent filings, industry reports, 2023.

More… ↓

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Drugs Protected by US Patent 11,040,032

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 11,040,032 ⤷  Start Trial Y ⤷  Start Trial
Omnivium Pharms NUMBRINO cocaine hydrochloride SOLUTION;NASAL 209575-001 Jan 10, 2020 RX Yes Yes 11,040,032 ⤷  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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