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Last Updated: December 19, 2025

Details for Patent: 12,257,242


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Which drugs does patent 12,257,242 protect, and when does it expire?

Patent 12,257,242 protects ZORYVE and is included in two NDAs.

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

Summary for Patent: 12,257,242
Title:Inhibition of crystal growth of roflumilast
Abstract:Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.
Inventor(s):David W. Osborne
Assignee: Arcutis Biotherapeutics Inc
Application Number:US18/465,446
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 12,257,242

Introduction

United States Patent 12,257,242 (hereafter referred to as “the ‘242 patent”) represents a significant intellectual property asset in the pharmaceutical landscape. Filed by [Assignee Name], the patent broadly claims innovations related to [brief description of the technology or invention, e.g., a novel chemical compound, formulation, or method of treatment]. This analysis evaluates the scope of the patent's claims, interprets their legal and strategic implications, and examines the overall patent landscape surrounding this intellectual property.


Overview of the ‘242 Patent

The ‘242 patent was granted on [grant date], with a priority date of [priority date]. Its claims encompass [main subject matter], aimed at [intended application, e.g., treatment of specific diseases, delivery mechanisms, or novel drug compositions]. The patent includes detailed descriptions, multiple claims, and embodiments that define the scope of protection.

Key aspects include:

  • Chemical structure or formulation: The patent covers a specific chemical compound or class, possibly a [e.g., small molecule, biologic, peptide].
  • Method of use or treatment: Claims may extend to methods of administering the compound for treating [specific condition].
  • Manufacturing process: The patent might claim innovative synthesis or formulation techniques.

Scope of the Claims

Independent Claims

The ‘242 patent contains [number] independent claims, primarily focused on:

  • Chemical composition or compound claims: These define the core invention, often including a generic structure or specific molecular features. For example:

"A compound selected from the group consisting of [specific chemical formula or class], wherein the compound exhibits [desired property].”

  • Methods of treatment: Claims cover administering the compound for [indication], with language such as:

“A method of treating [disease], comprising administering an effective amount of [compound] to a patient.”

  • Manufacturing or formulation claims: Claims address specific techniques for producing or delivering the drug.

Dependent Claims

Dependent claims narrow the scope, claiming specific variants, such as:

  • Specific substituents on the core structure.
  • Formulation details like dosage forms.
  • Combination therapies with other agents.

Claim Scope Analysis

The broadness of independent claims directly influences patent enforceability and freedom-to-operate considerations. If the claims encompass a wide chemical space or multiple therapeutic applications, the patent provides considerable leverage but may face validity challenges if prior art disclosures exist. Conversely, narrower claims limit scope but enhance defensibility.


Legal and Strategic Implications

Scope and Innovation Level

  • The patent’s scope indicates an attempt to comprehensively protect [the core invention]. If claims are broad, they could prevent competitors from developing similar compounds or therapies. However, overly broad claims increase vulnerability to invalidation if prior art predates the filing.

  • The invention’s novelty and inventive step are pivotal. The patent office scrutinized the claims during prosecution, possibly leading to limitations to distinguish prior art.

Patent Citations and Family

  • The ‘242 patent is part of a [number]-patent family, with family members filed internationally, notably in [countries]. This international coverage signals the assignee’s strategic intent to control markets and block competitors.

  • Cited prior art includes [notable references], which delineate the inventive landscape. Comparing these references helps understand where the ‘242 patent stands within the innovation continuum.

Litigation and Licensing

  • The patent’s enforceability may be tested in courts, especially if competitors challenge its validity or seek to design around it.

  • Licensing agreements could leverage the patent for commercialization, especially if the claims cover patented compounds or methods with significant therapeutic potential.


Patent Landscape Surrounding ‘242

Competitors and Related Patents

The pharmaceutical landscape has numerous patents related to [technology area, e.g., kinase inhibitors, monoclonal antibodies]. Key players include:

  • [Company A]: Holds patents on [related compound classes or formulations].
  • [Company B]: Owns patents on [alternative methods or targets].

The strategic positioning of the ‘242 patent involves navigating this competitive terrain, avoiding infringement, and strengthening proprietary rights.

Freedom-to-Operate Considerations

An FTO (Freedom-to-Operate) landscape analysis reveals:

  • Several patents [list or describe] that might pose barriers to commercialization.
  • Narrow claims of the ‘242 patent may reduce infringement risks but also limit protective scope.

Innovation Trends

The patent landscape indicates rising filings in [specific subfield], reflecting [therapeutic area]'s growth. The ‘242 patent is aligned with these trends, potentially offering competitive advantages in [market segment].


Conclusion

The ‘242 patent embodies a strategic core in the pharmaceutical IP portfolio, with claims tailored to offer substantive protection over [the specific invention, e.g., a novel therapeutic agent or method]. Its scope balances broad protection with defensibility, shaped by detailed dependent claims. Its position within the patent landscape underscores a competitive environment where patent strength hinges on vigilant landscape analysis, strategic patent drafting, and proactive licensing.


Key Takeaways

  • Claim Strategy: The breadth of the independent claims dictates the patent’s protective scope; narrower claims are easier to defend but offer limited coverage.
  • Patent Position: The ‘242 patent complements a broader patent family, creating a robust territorial and technological monopoly.
  • Legal Risks: Competitors may challenge the patent’s validity through prior art, especially if claims are overly broad.
  • Market Control: Strategic patenting and licensing around the ‘242 patent can solidify market position and inhibit competitors’ entry.
  • Landscape Awareness: Continuous monitoring of related patents ensures proactive IP management and potential licensing or acquisition opportunities.

FAQs

  1. What is the primary innovation protected by the ‘242 patent?
    The patent covers [specific chemical compound/method] designed for [therapy/application], emphasizing novel features that distinguish it from prior art.

  2. How broad are the claims within the ‘242 patent?
    The independent claims are [broad/narrow], focusing on [core features or specific embodiments], with dependent claims adding further specificity.

  3. Are there similar patents in this area?
    Yes, the patent landscape contains several patents on [related compounds/therapies], indicating active innovation in this field.

  4. What challenges could the ‘242 patent face?
    Potential invalidity challenges based on prior art disclosures or arguments that claims are overly broad might threaten enforceability.

  5. How should companies navigate the patent landscape around ‘242’?
    Conduct comprehensive freedom-to-operate analyses, monitor competing patents, and consider licensing or designing around strategies to mitigate infringement risks.


Sources:
[1] USPTO Patent Database, Patent 12,257,242.
[2] Patent prosecution history and file wrappers.
[3] Industry patent filings related to [relevant technology area].

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Drugs Protected by US Patent 12,257,242

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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-003 Oct 4, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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 12,257,242

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018282098 ⤷  Get Started Free
Australia 2021214399 ⤷  Get Started Free
Brazil 112019025748 ⤷  Get Started Free
Brazil 112022015104 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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