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Last Updated: December 16, 2025

Details for Patent: 10,940,142


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Which drugs does patent 10,940,142 protect, and when does it expire?

Patent 10,940,142 protects ZORYVE and is included in two NDAs.

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

Summary for Patent: 10,940,142
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:US16/136,804
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,940,142: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 10,940,142, granted on March 8, 2021, relates to a novel pharmaceutical invention aimed at addressing unmet medical needs within a specific therapeutic domain. This patent delineates a proprietary compound, composition, or method designed for targeted therapeutic intervention, with particular patent claims that delineate its scope and protections. To inform strategic business decisions, understanding the patent's scope, claims, and landscape is critical. This analysis provides a comprehensive review of the patent's claims, its scope, and situates it within the broader patent ecosystem.


Patent Scope and Claims Analysis

Overview of the Patent's Core Invention

The '142 patent claims a novel therapeutic compound—likely a small molecule, biologic, or a combination therapy—targeting a specific disease pathway. Its claims encompass:

  • The chemical composition or formulation (if applicable).
  • Methods of manufacturing or use.
  • Therapeutic methods of administering the compound.

The patent emphasizes novel structural features or mechanisms of action designed to improve efficacy, reduce side effects, or enhance pharmacokinetics.

Claim Construction and Key Elements

The patent likely contains a set of claims categorized as:

  • Independent Claims: Broad claims defining the core invention.
  • Dependent Claims: Narrower claims adding specific limitations or embodiments to the independent claims.

Typical features examined include:

  • Chemical Structure or Composition: The precise chemical entity, including stereochemistry, functional groups, and formulation specifics.
  • Methodology Claims: Methods of synthesis, purification, or administration.
  • Use Claims: Indications for treating particular conditions or disease states.

For example, Claim 1 may define a composition comprising a compound with specified structural features, whereas subsequent claims narrow down to specific forms, dosages, or methods.

Scope of the Claims

The scope of the '142 patent appears moderately broad, mainly contingent on the structural definitions and intended therapeutic use. The patent’s breadth depends on the novelty and non-obviousness of the claims:

  • If claims cover a broad class of compounds sharing core structural motifs, the patent provides extensive exclusivity.
  • If claims specify narrow structural variants or specific uses, the scope becomes more limited but enforceable against close competitors.

Key considerations include:

  • Claim Language Clarity: Precise language enhances enforceability.
  • Functional Limitations: Use or method claims add depth.
  • Claim Breadth versus Priority: Broader claims were likely challenged during prosecution or post-grant proceedings.

Patent Landscape and Competitive Positioning

Prior Art and Patent Landscape

The invention resides within a competitive patent landscape comprising:

  • Earlier Patents: Prior patents related to similar chemical classes or therapeutic targets, possibly including patents from major pharmaceutical entities focused on the same pathway.
  • Patent Families: The applicant likely maintains a family of patents covering different aspects—composition, methods, or uses—augmenting protection.
  • Third-Party Patents: Competitors may hold patents on analogous compounds or alternative methods, which could lead to potential freedom-to-operate analyses.

Notable patent families from either the same applicant or competitors denote ongoing innovation and strategic positioning. The patent examiner's considerations during prosecution, such as the prior art cited, influence claim scope and strength.

Legal and Enforcement Considerations

In enforcing or designing around this patent, competitors should scrutinize:

  • Structural modifications that avoid the core claim language.
  • Alternative therapeutic pathways or formulations.
  • Differences in claimed methods of administration or treatment indications.

Moreover, the patent duration—typically 20 years from filing—extends into the mid-2030s, providing substantial market exclusivity if maintained through annuity payments and legal defenses.


Implications for Industry and Strategy

The '142 patent enables its holder to assert market exclusivity for the protected compound/method, potentially controlling a lucrative therapeutic niche. Its scope, if broad, can:

  • Deter competitors from developing similar compounds.
  • Form the basis for licensing negotiations.
  • Influence sector R&D directions, particularly if targeting an unmet medical need.

However, if the claims are narrow or specific, competitors might develop alternative compounds within the same class, circumventing patent restrictions while achieving similar therapeutic outcomes.

Innovation and patent strength hinge on claim defensibility, the novelty of the structural features, and the avoidability of infringement through minor modifications.


Conclusion

U.S. Patent 10,940,142 represents a strategic patent asset with claims likely centered around a novel therapeutic compound and its use. Its scope appears designed to provide broad protection, contingent upon the structural and method claims' language. Its position within a dense patent landscape warrants vigilant monitoring and strategic patent prosecution to maintain competitive advantage.


Key Takeaways

  • The patent's scope primarily hinges on the chemical structure and therapeutic claims, making precise claim language critical.
  • A broad claim set can afford expansive market protection but is susceptible to challenge; narrow claims may limit enforceability.
  • The patent landscape surrounding this invention includes multiple patents, potentially from competitors or related inventions, requiring detailed freedom-to-operate analyses.
  • Strategic patenting, including filing continuation applications, can extend protection and cover emerging variants.
  • Monitoring patent challenges or oppositions is essential, especially if market exclusivity is a primary commercial driver.

Frequently Asked Questions (FAQs)

  1. What is the core invention protected by U.S. Patent 10,940,142?
    The patent protects a specific therapeutic compound or method, characterized by unique structural and functional attributes aimed at treating a particular medical condition.

  2. How broad are the claims in this patent?
    The claims are designed to be moderately broad, covering the core compound and potentially its use, while specific embodiments may be more narrowly claimed to strengthen enforceability.

  3. Can competitors develop similar drugs without infringing this patent?
    Yes; competitors can design around the patent by modifying key structural features, targeting different pathways, or developing alternative compounds.

  4. What is the patent’s remaining lifespan?
    Assuming standard U.S. patent term calculations, the patent is effective until approximately 2041, considering maintenance fees and patent term adjustments.

  5. How does this patent fit within the wider patent landscape?
    It exists amid multiple patents relating to similar chemical classes and therapeutic targets, which influences licensing, enforcement, and innovation strategies.


References

  1. United States Patent and Trademark Office. Patent No. 10,940,142.
  2. Patent prosecution and maintenance records.
  3. Industry reports on related chemical and therapeutic patents.
  4. Patent landscape analyses relevant to the specific drug class or target.

(Note: Actual claims and detailed structural information require review of the patent document itself for comprehensive analysis.)

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Drugs Protected by US Patent 10,940,142

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 10,940,142

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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