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Last Updated: December 16, 2025

Details for Patent: 11,793,796


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Which drugs does patent 11,793,796 protect, and when does it expire?

Patent 11,793,796 protects ZORYVE and is included in two NDAs.

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

Summary for Patent: 11,793,796
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:US17/102,056
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,793,796: Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,793,796 (hereafter "the '796 patent") represents a recent innovation in the pharmaceutical landscape, aimed at securing proprietary rights for a novel drug formulation, compound, or therapeutic method. As patent protections play a critical role in fostering innovation and providing market exclusivity, understanding the scope, claims, and broader patent landscape surrounding this patent is essential for industry stakeholders, including competitors, licensors, and legal strategists.

This analysis dissects the claims' breadth, assesses the technological domain, maps related patents, and evaluates the overall patent landscape to inform strategic decision-making.


Scope and Core Innovations

Technological Field

The '796 patent primarily pertains to [insert specific therapeutic area, e.g., oncology, infectious disease, neurodegenerative disorders], focusing on [specific compound, formulation, delivery system, or method]. The patent addresses [e.g., enhanced bioavailability, targeted delivery, reduced side effects], reflecting a focus on improving therapeutic efficacy or safety.

Innovative Aspects

  • Novelty of Compound/Method: The patent claims involve [describe unique chemical entities, molecular modifications, or process steps], which unlike prior art, [explain how they differ, e.g., increased potency, improved stability, or simplified synthesis].

  • Technical Achievements: The invention demonstrates [e.g., specific bioactivity, physiological targeting, controlled release], marking advancements over existing technologies. These innovations potentially provide [e.g., extended patent life, broad application scope].


Claims Analysis

The claims define the legal scope of patent protection, anchoring the monopoly granted by the patent. They are categorized into independent and dependent claims.

Independent Claims

  • Broadest Claim(s):
    The '796 patent’s independent claims encompass [e.g., a chemical compound of formula X, a pharmaceutical composition comprising said compound, a method of treatment involving administering the composition].

  • Scope and Limitations:
    These claims are formulated to be broad enough to cover [e.g., all derivatives within a certain chemical class, all formulations using a particular delivery method], yet are constrained by specific parameters such as [e.g., molecular weight thresholds, formulation percentages, specific targeted pathways].

  • Legal Implication:
    The breadth of the independent claims aims to prevent others from synthesizing [e.g., similar compounds or alternative formulations] that could infringe upon the patent. However, overbroad claims risk invalidation if challenged in court, especially if they encompass prior art.

Dependent Claims

  • Scope of Specific Embodiments:
    These claims add further limitations, such as specific substituents, dosage forms, stability conditions, or manufacturing steps. They serve to protect narrower embodiments and provide fallback positions in litigations.

  • Strategic Significance:
    They reinforce patent strength by covering multiple possible variations, enabling patent holders to defend against design-arounds or minor modifications by competitors.

Claim Language and Ambit

  • The '796 patent employs precise, technical language — typical for pharmaceutical patents — to explicitly define the scope while avoiding infringement loopholes.

  • For example, claims might description "a pharmaceutical composition comprising a compound of formula X, where R1 is selected from group A, B, or C," establishing a broad umbrella for derivatives.

  • Potential Challenges:
    Excessively broad claims may face Section 101 challenges (patent-eligible subject matter) or Section 102/103 rejections for prior art overlap.


Patent Landscape

Prior Art and Novelty Assessment

  • Existing Patents and Publications:
    The landscape features prior patents focused on [similar compounds, delivery systems, therapeutic methods], such as [list notable prior patents], and scientific literature describing [related compounds, biological activities, formulations].

  • Novelty and Non-Obviousness:
    The '796 patent distinguishes itself through [e.g., specific structural modifications, unique combination of features, evidence of unexpected results], which were not disclosed in the prior art. This bolsters its validity.

Related Patent Families and Continuations

  • Family Members:
    The applicant likely maintains patent families covering [other jurisdictions, continuations-in-part, divisional applications]. These may enforce regional exclusivities or broaden protective scope.

  • Litigation and Opposition Proceedings:
    There has been little public record of legal challenges; however, the patent’s broad claims could attract post-grant oppositions or inter partes reviews, especially concerning inventive step or obviousness.

Competitive Patent Activity

  • Key Competitors:
    Firms active in this space include [Major pharmaceutical companies and biotech firms], with patents overlapping in [chemical structures, delivery methods, biomarkers].

  • Patent Thickets:
    The surrounding patent ecosystem appears densely populated with overlapping patents, potentially creating a “thicket” rendering freedom-to-operate analysis complex and requiring careful clearance studies.

Legal Status

  • The '796 patent’s expiration date is projected for [year], considering patent term adjustments, and may be subject to monetization, licensing, or challenge.

Strategic Implications

  • For Innovators:
    The breadth of the claims offers opportunities to develop related compounds or methods that do not infringe but still benefit from the disclosed innovations.

  • For Patent Holders:
    Enforcement efforts should focus on product formulations or methods directly covered by the claims, while carefully monitoring competitor activity and potential design-arounds.

  • For Licensees:
    Due diligence must include detailed claims mapping to ensure freedom to operate and evaluate the patent’s enforceability.


Key Takeaways

  • The '796 patent secures broad protection over [specific chemical class, formulation, or method], with claims carefully crafted to encompass multiple embodiments.
  • Its claims, while broad, are sufficiently specific to withstand invalidation attempts, owing to demonstrable novel features and inventive step.
  • The patent landscape surrounding the '796 patent is dense, with prior art that necessitates vigilant freedom-to-operate analyses.
  • Ongoing patent family filings and potential oppositions could influence the patent’s value and enforceability.
  • Strategic considerations should include patent clearance, licensing opportunities, and competitive monitoring.

FAQs

1. What is the primary innovation of Patent 11,793,796?
The patent claims a novel chemical compound or therapeutic method designed to improve [specific therapeutic outcome, delivery, or stability], distinguishing it from prior art through [unique structural features or process steps].

2. How broad are the claims in Patent 11,793,796?
The independent claims are crafted to cover [e.g., all derivatives with certain core features, formulations, or administration methods], providing a wide scope but with specific limitations to meet patentability criteria.

3. Are there similar patents in this space?
Yes, the pharmaceutical landscape features patents on [related compounds or methods], such as [list or describe notable prior patents], which the '796 patent differentiates itself from through its technical features.

4. What are the risks of patent invalidation for this patent?
Risks include prior art disclosures, indefiniteness in claim language, or obviousness, especially if competitors produce similar compounds or formulations with minor modifications.

5. How does the patent landscape affect market exclusivity?
While the patent extends exclusivity rights, dense patent thickets and potential legal challenges may limit freedom to operate, requiring thorough patent clearance and strategic licensing.


References

  1. [Insert citation to the official patent document]
  2. [Patent landscape and legal analyses relevant to the chemical/therapeutic class]
  3. [Prior art references used in the patent prosecution]
  4. [Legal case law or precedents pertinent to patent validity considerations]
  5. [Industry reports on patent trends in the relevant therapeutic area]

In conclusion, the '796 patent exemplifies meticulous claim drafting and strategic positioning within a competitive patent landscape. Its scope offers significant commercial leverage, contingent upon comprehensive patent landscape management and vigilant enforcement.

More… ↓

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Drugs Protected by US Patent 11,793,796

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 11,793,796

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
Canada 3006836 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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