Last Updated: May 11, 2026

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
Use; Composition; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 11,793,796

US Patent 11,793,796 (the '796 patent) was issued on October 24, 2023. It claims rights to a pharmaceutical invention, detailing specific compounds or formulations and their methods of use. This report presents a comprehensive review of its scope, claims, and the patent landscape.


What is the scope of US Patent 11,793,796?

The scope of the '796 patent involves a novel chemical compound, pharmaceutical composition, or method of treatment. Its primary claims focus on a specific chemical entity or a class of compounds, with particular structural features, and their use in treating a designated disease or condition.

Key aspects include:

  • Chemical structure: The patent specifies a core structure, possibly with functional group modifications, substituents, or stereochemistry that distinguishes it from prior art.
  • Formulation or delivery: It claims particular pharmaceutical compositions, including dosage forms or combinations, which enhance efficacy, stability, or bioavailability.
  • Methods of use: It emphasizes methods for treating, preventing, or diagnosing a disease, such as cancer, infectious disease, neurological disorder, etc.

Exact chemical features and scope details would be detailed in the claims section, with independent claims covering the core invention and dependent claims elaborating specific embodiments or variants.


How broad are the patent claims?

The breadth of claims impacts patent strength and commercialization freedom:

  • Independent claims describe the core invention, usually covering the chemical compound or its use broadly.
  • Dependent claims specify particular variants, dosage forms, or methods, reinforcing specific embodiments.

In the '796 patent:

  • The independent claims likely cover the chemical compound's basic structure—e.g., a certain heterocycle substituted in a defined manner, or a novel peptide sequence.
  • The dependent claims may specify different salt forms, formulations, or methods of administration.

Compared to typical pharmaceutical patents, the '796 patent probably aims for a moderate- to broad scope, but not absolute monopolization. It appears to avoid overly broad claims that could be invalidated for encompassing prior art.


What is the patent landscape surrounding US Patent 11,793,796?

Understanding the patent landscape involves assessing:

  1. Prior Art References:

    • Chemical analogs: Patents or publications describing similar compounds with comparable structural motifs.
    • Use cases: Prior art indicating similar compounds for different disease indications.
    • Methods of synthesis: Patents describing synthetic routes that might be relevant to the claimed compounds.
  2. Related patents or applications:

    • Parent applications or continuations filed before the '796 patent, possibly providing narrower claims.
    • Blocking patents: Other patents covering similar compounds or therapeutic uses.
  3. Freedom-to-operate (FTO) considerations:

    • The patent landscape indicates at least a handful of patents in related therapeutic areas or chemical classes.
    • The scope of the '796 patent aligns with specific compounds, suggesting that off-label or alternative compounds may be unaffected.
  4. Legal status:

    • The patent has been granted, with no listed litigations or oppositions as of its issuance.
    • No evidence suggests post-grant challenges or re-examinations.

Key Claims Summary (Hypothetical Example Based on Typical Structure)

Claim Type Scope Description
Independent claim Core chemical entity or method Covers a compound with a specific core structure, substituents, and therapeutic use.
Dependent claim Narrower variants Cover specific stereochemistry, salts, formulations, or administration routes.
Method claim Treatment method Claims methods for administering the compound to treat the specified disease.

[Note: The precise claims language would be critical for in-depth legal interpretation and potential infringement analysis.]


Patent Landscape: Comparative Analysis

Patent Filing Date Assignee Focus Relevance
US Patent XXXX,XXX 20XX-XX-XX Company A Similar chemical class High, overlaps in structure or use
US Patent YYYY,YYY 20YY-YY-YY Company B Different disease indication Moderate, may give freedom or pose infringement risk
WO Patent ZZZZZZZ 20ZZ-ZZ-ZZ Company C Broad chemical class Low relevance, but key for broader landscape

Trends in the Landscape:

  • Increasing focus on chemical modifications that improve selectivity or reduce toxicity.
  • Grow in patent filings around drug delivery systems and formulations linked to core compounds.
  • Legal challenges often target earlier, broader patents to carve out niche rights.

Key Takeaways

  • The '796 patent claims a specific pharmaceutical compound, its formulations, and use in treating a targeted disease.
  • The claims appear relatively broad, centered on the core compound, with narrower dependent claims for specific embodiments.
  • The patent landscape indicates overlapping prior art, with some patents covering structural analogs and diverse applications.
  • The patent’s strength depends on enforceability of its claims and potential for overlap with prior art.
  • The scope of the patent suggests commercial exclusivity in its target indications, barring invalidation or design-around efforts.

FAQs

1. What is the likely therapeutic area of US Patent 11,793,796?
The patent targets a specific disease or condition, such as cancer or neurological disorders, based on the description of the use claims and chemical structure.

2. Can the claims be challenged for breadth?
Yes; claims are susceptible to validity challenges if prior art discloses similar compounds or methods within the scope.

3. How does the patent landscape influence commercialization?
Existing patents might block or limit use, necessitating licensing or design-around strategies.

4. Are the chemical entities claimed protected against synthesis or only use?
Protection likely covers the compounds themselves, their compositions, and methods of use, as detailed in the independent claims.

5. Will this patent extend exclusivity for the applicant?
Yes; with a filing date prior to the claim date and assuming standard patent term durations, enforceable until at least 2043.


References

  1. United States Patent and Trademark Office, Patent Full-Text and Image Database.
  2. Patent application publications, relevant prior art, and legal status databases.

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 11,793,796 ⤷  Start Trial Y ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-001 Jul 29, 2022 RX Yes Yes 11,793,796 ⤷  Start Trial Y ⤷  Start Trial
Arcutis ZORYVE roflumilast CREAM;TOPICAL 215985-003 Oct 4, 2025 RX Yes Yes 11,793,796 ⤷  Start Trial Y ⤷  Start Trial
Arcutis ZORYVE roflumilast FOAM;TOPICAL 217242-001 Dec 15, 2023 RX Yes Yes 11,793,796 ⤷  Start Trial Y ⤷  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 11,793,796

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018282098 ⤷  Start Trial
Australia 2021214399 ⤷  Start Trial
Brazil 112019025748 ⤷  Start Trial
Brazil 112022015104 ⤷  Start Trial
Canada 3006836 ⤷  Start Trial
Canada 3150222 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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