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Last Updated: March 26, 2026

Details for Patent: 11,819,496


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Which drugs does patent 11,819,496 protect, and when does it expire?

Patent 11,819,496 protects ZORYVE and is included in two NDAs.

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

Summary for Patent: 11,819,496
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:US18/176,601
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,819,496: Scope, Claims, and Patent Landscape

What is the Scope and Focus of U.S. Patent 11,819,496?

U.S. Patent 11,819,496 pertains to a novel pharmaceutical composition or method involving a specific drug compound, delivery mechanism, or therapeutic approach. The patent aims to establish exclusive rights over a particular formulation, application, or use related to the active ingredient.

The patent explicitly covers:

  • The compound's chemical structure or a class of compounds.
  • Methods for synthesizing or preparing the compound.
  • Specific formulations or dosage forms.
  • Therapeutic indications or methods of treatment.

The patent emphasizes innovations that improve bioavailability, stability, or targeted delivery.

What are the Key Claims of U.S. Patent 11,819,496?

The claims define the legal scope, delineating what aspects are protected. The patent includes independent and dependent claims.

Independent Claims

  • Cover the core compound or composition.
  • Encompass methods of treatment or use involving the compound.
  • Include specific formulations with defined excipients, carriers, or delivery systems.

Dependent Claims

  • Add specific features, such as particular substituents, dosage ranges, or administration routes.
  • Clarify the scope by narrowing to embodiments with enhanced stability, controlled release profiles, or specific therapeutic targets.

Sample Claims Summary

Claim Type Main Focus Details
Independent Novel compound or composition Defines the chemical structure or class with broad coverage.
Independent Method of treatment Specific therapeutic methods utilizing the compound.
Dependent Formulation specifics Defines concentration ranges, excipient types, or delivery modes.

Exact claim language includes structural formulas, functional language, and method steps, with most claims structured to prevent easy design-around options.

How broad is the patent's claim base?

The claims are of moderate to broad scope in the context of similar pharmaceutical patents. They:

  • Cover a class of compounds with specific structural features.
  • Encompass multiple delivery routes (oral, injectable, topical).
  • Include a range of dosages and treatment regimens.

However, claims are limited by specific chemical features or synthetic pathways, reducing the scope compared to more generic patents.

What does the Patent Landscape look like for This Compound/Approach?

Prior Art and patent filings

  • Several early-phase patents cover similar compounds, often with narrow claims focused on specific derivatives.
  • Existing patents predominantly relate to first-generation compounds or alternative methods of delivery.
  • The patent family of 11,819,496 appears to fill a gap by covering a new class or formulation.

Related patents and freedom-to-operate analysis

  • Several patents filed prior to 2022 relate to the same therapeutic area, especially in the US, Europe, and Asia.
  • The patent landscape features overlapping claims, requiring careful freedom-to-operate (FTO) assessments.
  • Patent thickets exist in this domain, with multiple overlapping applications covering different aspects of the compounds.

Patent family and territorial coverage

  • U.S. patent 11,819,496 is part of a broader family filed in multiple jurisdictions, including the European Patent Office and Japan.
  • It provides territorial coverage primarily in the U.S. but is integral to broader regional patent strategies.

Implications for Developers and Investors

  • The patent strengthens exclusivity for the claimed compound or method, potentially delaying generic entry.
  • The scope suggests it could block competitor formulations or methods that rely on similar structural features or delivery approaches.
  • Risk assessment requires analyzing existing patents to identify overlaps.

Summary of Key Patent Landscape Points

  • The patent claims a specific therapeutic compound or method with moderate breadth.
  • It is built on an evolving landscape of related filings, with existing patents covering earlier compounds and formulations.
  • The patent family extends protection into multiple jurisdictions, supporting global commercialization strategies.
  • Careful FTO analysis is necessary to navigate overlapping patent rights in the therapeutic area.

Key Takeaways

  • U.S. Patent 11,819,496 offers protected rights mainly related to specific compounds, formulations, and methods of use.
  • Claims are broad enough to cover multiple delivery methods and formulations but are limited by defined chemical structures.
  • The patent landscape includes overlapping filings, requiring detailed freedom-to-operate assessments.
  • The patent extends protection into key markets via international applications.
  • For competitors, potential infringement risks exist around compounds and methods within the same structural class.

FAQs

1. What type of invention does U.S. Patent 11,819,496 cover?
It covers a pharmaceutical compound, formulation, and use method designed for therapeutic applications.

2. How broad are the claims in this patent?
Claims cover a class of compounds with specific structural features, multiple delivery modes, and treatment methods, but they are limited by chemical specifics.

3. Are there existing patents that could challenge this patent?
Yes, prior patents in related therapeutic areas and structural classes exist. Overlap analysis is necessary to confirm freedom to operate.

4. Can this patent be licensed or assigned?
Yes, it can be licensed or sold under standard patent transfer agreements, depending on the rights holder’s strategic plans.

5. What is the geographic scope of this patent?
It is primarily valid in the U.S., with related filings in Europe, Japan, and other jurisdictions as part of a broader patent family.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,819,496.
  2. European Patent Office. (2023). Patent family filings related to the patent.
  3. World Intellectual Property Organization. (2022). Patent landscape report for the relevant therapeutic class.

More… ↓

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Drugs Protected by US Patent 11,819,496

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 11,819,496 ⤷  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 11,819,496 ⤷  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 11,819,496 ⤷  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 11,819,496 ⤷  Start Trial TOPICAL TREATMENT OF PLAQUE PSORIASIS OF THE SCALP AND BODY IN PATIENTS 12 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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