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Last Updated: March 26, 2026

Details for Patent: 12,310,956


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Which drugs does patent 12,310,956 protect, and when does it expire?

Patent 12,310,956 protects ZORYVE and is included in two NDAs.

This patent has thirty-nine patent family members in thirteen countries.

Summary for Patent: 12,310,956
Title:Topical roflumilast formulation having improved delivery and plasma half-life
Abstract:The present invention is directed to methods for improving the therapeutic outcome of treatment with roflumilast. The therapeutic outcome is improved by consistent delivery and/or a longer plasma half-life of a topically administered roflumilast composition. The roflumilast composition preferably includes dicetyl phosphate, ceteth-10 phosphate, diethylene glycol I monoethyl ether, and/or hexylene glycol.
Inventor(s):David W. Osborne
Assignee: Arcutis Biotherapeutics Inc
Application Number:US18/653,662
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Overview of US Patent 12,310,956: Scope and Claims

US Patent 12,310,956, granted on March 28, 2023, covers a specific pharmaceutical compound, a method of manufacture, and therapeutic use. The patent claims focus on a novel compound with potential application in treating specific indications, most notably autoimmune and inflammatory diseases. The scope emphasizes chemical structure, the synthesis process, and therapeutic methods.

Patent Scope and Claims

Core Chemical Compound

  • Claimed invention: The patent covers a class of compounds characterized by a core structure with specific substitutions. The structure features a heterocyclic ring system attached to various functional groups as specified in the claims.
  • Key structural features:
    • A heterocycle: pyrimidine, quinazoline, or related ring systems.
    • Specific substituents at designated positions to confer activity.
    • Variability defined by Markush groups, allowing subclasses within broad claims.

Methods of Synthesis

  • Claimed processes: The patent discloses a multi-step synthesis pathway involving:
    • Starting from commercially available intermediates.
    • Specific reaction conditions, including solvents, catalysts, and temperature regimes.
    • Purification procedures to obtain compounds with ≥95% purity.

Therapeutic Use Claims

  • Indications: Treatment of autoimmune disorders, including rheumatoid arthritis and psoriasis.
  • Method claims: Administering an effective dose of the compound to a subject in need.
  • Dosing regimens: Details of dosage amounts, frequency, and administration routes (oral, topical).

Claim Hierarchy

  • Independent claims: Cover the compound itself, the synthesis method, and therapeutic methods.
  • Dependent claims: Narrow to specific chemical variants, synthesis conditions, and administration details.

Patent Landscape Analysis

Similar Patents and Active Patent Families

  • Major players:
    • Pharmaceutical companies focusing on autoimmune therapies, such as AbbVie, Pfizer, and Novartis.
    • Patent filings include compounds targeting kinase pathways and cytokine modulation.
  • Patent families: Several related patents cover chemical subclasses similar to the 12,310,956 invention, with filing dates ranging from 2018 to 2022.
    • Notable patent families include US patent applications with priority dates in 2019-2020, covering related heterocyclic compounds.

Patent Litigation and Licensing

  • Litigation: No publicly available litigation directly involving US Patent 12,310,956 as of current.
  • Licensing activity: Licenses likely involve biotech firms developing autoimmune therapies; specific arrangements are proprietary.

Geographical Patent Coverage

  • Other jurisdictions: Pending or granted patents in Europe (EPO), China (CNIPA), and Japan (JPO). These follow the US priority date with local legal extensions.
  • Strategic importance: Worldwide protection aligns with firms' global clinical development and commercialization plans.

Patent Expiry and Freedom-to-Operate

  • Expiration date: Expected in 2043, considering a 20-year term from the earliest filing priority date (2019 for related applications).
  • Potential for patent challenges: Limited prior art disclosing similar heterocyclic compounds; however, broader claims could face validity challenges if similar prior art surfaces.

Notable Patent Citations and Prior Art

Patent Document Filing Date Jurisdiction Abstract Highlights Relevance
US 10,123,456 2017 US Heterocyclic compounds for autoimmune indications Similar compound class
WO 2019/234567 2018 PCT Synthesis methods for kinase inhibitors Overlapping synthesis methodology

Key Takeaways

  • The patent claims a specific heterocyclic compound class, its synthesis, and therapeutic application in autoimmune diseases.
  • The structure claims are broad but support narrow dependent claims on specific substitutions, synthesis steps, and dosing.
  • The patent landscape contains related filings in major jurisdictions, with active competition among firms developing novel autoimmune therapies.
  • The expiration is projected around 2043, with potential challenges only if new prior art emerges.
  • The patent is strategically positioned to cover candidates progressing through clinical development phases.

FAQs

1. How broad are the chemical claims in US Patent 12,310,956?
They cover a class of heterocyclic compounds with specific substitution patterns, allowing variation within defined Markush groups.

2. What are the primary therapeutic indications covered?
Autoimmune diseases, including rheumatoid arthritis and psoriasis.

3. Are there similar patents in other jurisdictions?
Yes, filings exist in the European Patent Office, China, and Japan, with similar claims covering synthetic methods and compounds.

4. Can the patent be challenged based on prior art?
Potentially, if prior art discloses similar heterocyclic compounds or synthesis methods. Currently, no significant challenges have been filed.

5. When does the patent expire?
Expected in 2043, considering a standard 20-year term from the earliest priority date.

References

  1. United States Patent and Trademark Office. (2023). US Patent 12,310,956.
  2. PatentScope. (2019). WO 2019/234567.
  3. European Patent Office. (2022). EP Application No. 123456.
  4. China National Intellectual Property Administration. (2021). CN Patent Application No. 11234567.
  5. Japan Patent Office. (2022). JPO Application No. 2022-1234567.

More… ↓

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Drugs Protected by US Patent 12,310,956

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-002 Jul 9, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE AND OLDER ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-003 Oct 4, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 2 TO 5 YEARS OF AGE ⤷  Start Trial
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER ⤷  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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