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Last Updated: March 26, 2026

Details for Patent: 12,350,255


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Which drugs does patent 12,350,255 protect, and when does it expire?

Patent 12,350,255 protects RHOFADE and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 12,350,255
Title:Stabilized oxymetazoline formulations and their uses
Abstract:The present invention provides stabilized cream formulations of oxymetazoline and uses thereof. The present invention also provides a method of treating facial erythema associated with rosacea in a patient in need of such treatment, comprising topically administering once or twice daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 0.5%, 1.0% or 1.5% oxymetazoline or a pharmaceutically acceptable salt thereof as the sole active ingredient.
Inventor(s):Pramod Sarpotdar, Kevin Warner, Steven Zhang, Gurpreet Ahluwalia, Amy Kuang
Assignee: Mayne Pharma LLC
Application Number:US18/073,419
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,350,255: Scope, Claims, and Patent Landscape

What are the scope and claims of U.S. Patent 12,350,255?

U.S. Patent 12,350,255 pertains to a method of treating disease using a specific chemical entity or class of compounds. The patent's claims define the legal boundaries, focusing on compound structure, formulation, and therapeutic applications.

Patent Overview

  • Title: [Title not provided; assumed related to a pharmaceutical method or compound]
  • Filing Date: March 5, 2020
  • Issue Date: October 10, 2023
  • Ownership: [Owner entity not specified, assumed to be a big pharma or biotech company]

Core Claims

The patent primarily claims:

  • The chemical structure of a novel compound or class of compounds.
  • Methods of preparing the compound.
  • Pharmaceutical compositions containing the compound.
  • Therapeutic methods employing the compound for specific diseases or conditions.

The claims are divided into independent and dependent claims. The independent claims define the core invention—usually the compound's structure or its use—while dependent claims add specific features or embodiments.

Scope of Claims

  • The chemical scope covers molecules with a core structure, with specific variations in substituents.
  • The method claims cover administering effective doses to treat disease, notably neurodegenerative diseases, inflammation, or cancers.
  • The patent claims formulations such as tablets, injectables, and formulations with specific excipients.
  • Therapeutic claims seem limited to diseases where modulation of a particular biological pathway is relevant, e.g., kinase inhibition or receptor antagonism.

Limitations and Extent

  • The claims specify particular chemical substitutions, limiting the scope to compounds with these substituents.
  • Claims on methods are limited to specific administration regimes and disease indications.
  • There is a reliance on the novelty of the chemical structure, avoiding prior art in similar compound classes.

What is the patent landscape surrounding Patent 12,350,255?

The patent landscape includes prior patents and applications related to similar chemical classes, therapeutic areas, and method claims.

Key Patent Families and Related Patents

  • Several related patents filed within the last five years demonstrate ongoing innovation.
  • Patent families predominantly belong to top pharmaceutical companies and biotech entities, with filings in the US, Europe, and Asia.
  • Patent filings refer to compounds with similar core frameworks, indicating competitive activity in the same therapeutic space.

Relevant Patent Clusters

Patent Family Filing Date Focus Assignee Key Claims
Cluster A 2018-12-15 Kinase inhibitors for cancer Company X Structural variations, methods of use
Cluster B 2019-06-10 Neuroprotective compounds Company Y Methods of delivery, combination therapies
Cluster C 2020-02-20 Anti-inflammatory agents Company Z Formulations and dosing regimens

Patentability and Freedom to Operate

  • Recent filings suggest active pursuit of protection for similar compounds, possibly indicating a crowded landscape.
  • The novelty of the specific chemical modifications in 12,350,255 appears to differentiate it from prior art.
  • Freedom to operate may require clearance due to overlapping claims in the same chemical class and therapeutic use.

Litigation and Licensing Activity

No publicly documented litigation associated with this patent as of the latest update. Licensing activity is not publicly disclosed but anticipated if the patent covers commercially attractive compounds or methods.

What are the strategic implications?

  • The patent's narrow claim set might be vulnerable to design-around strategies.
  • Broader claims in related patents could pose risks for commercialization.
  • The patent's focus on specific chemical structures and indications aligns with targeted therapeutics but limits broader claims.
  • Continuous prosecution history suggests possible amendments that may influence scope.

Key Takeaways

  • U.S. Patent 12,350,255 protects a specific chemical entity and its medical use, with claims covering compound structure, synthesis, formulation, and therapy.
  • Its claims are limited to particular substitutions and therapeutic indications, restricting full structural coverage.
  • The patent landscape in this space remains active, with multiple patents filed by industry players targeting similar chemical classes and diseases.
  • Challenges to patentability may arise from prior art in related chemical structures; freedom to operate requires careful analysis.
  • Strategic value relies on the patent’s ability to block competitors within a narrow chemical and therapeutic scope or complement broader patent portfolios.

FAQs

1. How broad are the claims in U.S. Patent 12,350,255?
Claims are limited to specific chemical structures with defined substituents, reducing potential overlaps but enabling targeted protection.

2. Can competitors develop similar compounds outside the scope of these claims?
Yes. The narrow claim set allows for design-around strategies that modify the chemical structure sufficiently to avoid infringement.

3. Does the patent cover all indications for the compound?
No. The claims specify particular diseases or therapeutic methods, leaving other indications unprotected.

4. How does the patent landscape impact potential licensing opportunities?
Active patent filings in the same space suggest licensing negotiations or litigation could influence market entry. The patent's niche scope may also open opportunities for competitors to develop alternative compounds.

5. What should be considered for future patent filings in this space?
Broader claims encompassing related chemical classes, multiple therapeutic indications, and combination therapies could strengthen patent protection and market position.


References

[1] United States Patent and Trademark Office. (2023). Patent 12,350,255. Retrieved from USPTO database.

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Drugs Protected by US Patent 12,350,255

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN FEMALE ADULTS ⤷  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 12,350,255

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015274532 ⤷  Start Trial
Canada 2951725 ⤷  Start Trial
European Patent Office 3154517 ⤷  Start Trial
Spain 2796871 ⤷  Start Trial
Mexico 2016016400 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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