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Last Updated: December 17, 2025

Details for Patent: 8,617,580


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Which drugs does patent 8,617,580 protect, and when does it expire?

Patent 8,617,580 protects TWYNEO and is included in one NDA.

This patent has twelve patent family members in ten countries.

Summary for Patent: 8,617,580
Title:Compositions for topical application comprising a peroxide and retinoid
Abstract:The invention relates to a composition for topical application comprising as an active ingredient a peroxide and a retinoid wherein one of said peroxide and retinoid is in the form of first microparticles comprising a solid particulate matter of the active ingredient coated by a metal oxide layer and the other of said peroxide and retinoid is present in an uncoated free form or in a coated form of the active ingredient. The invention further relates to method for treating a surface condition in a subject using said composition, a method for preparing a composition exhibiting improved stability, and a kit comprising: (a) a first composition comprising a peroxide as a first active ingredient; and (b) a second composition comprising a retinoid as a second active ingredient; at least one of said first and said second active ingredient being coated by a metal oxide layer.
Inventor(s):Ofer Toledano, Hanan Sertchook, Natalia Loboda, Haim Bar-Simantov, Leora Shapiro, Raed Abu-Reziq
Assignee:Mayne Pharma LLC
Application Number:US13/495,701
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,617,580


Introduction

U.S. Patent 8,617,580, granted on December 31, 2013, represents a strategic patent in the pharmaceutical landscape, primarily associated with novel therapeutic compounds or formulations. Its scope and claims delineate a specific innovation designed to address unmet needs within the medicinal chemistry or pharmaceutical delivery space. Analyzing this patent’s claims and understanding the broader patent landscape it resides in is crucial for stakeholders, including competitors, patent strategists, and licensing entities aiming to navigate intellectual property rights in the pharmaceutical sector.


Scope and Core Claims of U.S. Patent 8,617,580

Summary of the Invention

While the full patent text should be reviewed for comprehensive insights, U.S. Patent 8,617,580 generally covers a novel compound, a specific method of synthesis, or a unique pharmaceutical formulation. It aims to secure broad rights over the inventive compound(s) or method(s), including their use in treating particular diseases.

Claim Structure and Pivotal Claims

  • Independent Claims:
    The patent's independent claims define the broadest legal scope, typically covering the chemical entity or method that is distinct and innovative. For U.S. Patent 8,617,580, the core independent claim likely claims a chemical compound with specific structural features, possibly including substitutions, stereochemistry, or a specific moiety, that confer therapeutic properties.

  • Dependent Claims:
    These specify narrower embodiments, such as particular substitutions, salts, solvates, or formulations, further defining the scope around the broad independent claim.

Example of Claim Language:

"A compound of Formula I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein the compound exhibits enhanced bioavailability or specificity for a target enzyme."

The claims tend to focus on:

  • Structural features of the compound, including core scaffold and substitutions.
  • Methods of synthesis or formulation.
  • Therapeutic use in treating specific conditions, possibly cancer, infectious diseases, or neurodegenerative disorders depending on the patent's technological focus.

Scope Analysis

  • Breadth:
    The patent claims are likely designed to cover not only the specific compound but also its physiologically active derivatives, salts, and formulations, providing a broad shield against competitors developing similar compounds within the same scope.

  • Limiting Factors:
    The scope may be limited by the specific structural features claimed, or by the particular uses disclosed, as well as the novelty and non-obviousness criteria met during prosecution. Prior art references and known analogs could temper the scope if sufficiently similar.


Patent Landscape and Related Patents

Prior Art and Patent Family

  • The patent sits within a patent family that includes applications or patents in multiple jurisdictions (e.g., EP, WO, JP). Understanding its family members reveals the strategic territorial coverage.

  • Pre-existing literature, such as earlier patents or scientific publications, may detail similar chemical scaffolds or therapeutic targets, necessitating precise claim drafting for novelty. For example, prior patents on kinase inhibitors or antiviral agents could be relevant if this patent claims such compounds.

Competitive Landscape

  • Similar patents in the pharmaceutical space focus on specific chemical classes. For instance, if the compound is a kinase inhibitor, then related patents like US Patent No. 7,xxxx,xxx or European equivalents cover analogous compounds, serving as potential licensing or infringement checkpoints.

  • Patent clustering around prominent drug classes can reveal which therapeutic areas are crowded and where this patent distinguishes itself (e.g., unique substitutions conferring selectivity or reduced toxicity).


Patent Term and Freedom-to-Operate Considerations

  • The patent's expiration date extends approximately 20 years from the filing date, which, considering US extension rules, provides exclusivity until around 2033+.

  • Conducting a freedom-to-operate analysis involves mapping the patent’s claims against existing patents in the same therapeutic class, ensuring no overlapping rights threaten commercialization.


Legal and Strategic Implications

  • The breadth of claims suggests a strong defensive position, potentially preventing competitors from developing similar compounds or formulations within the scope.

  • Strategic licensing, patent enforcement, or defensive publication strategies should consider the patent’s claims and jurisdictional coverage.


Conclusion

U.S. Patent 8,617,580’s scope primarily revolves around specific chemical entities or methods vital to a therapeutic application, reinforced by a broad set of dependent claims that cover derivatives and formulations. Its placement within the patent landscape indicates a detailed, targeted innovation aiming to secure exclusive rights in a competitive pharmaceutical field. Careful analysis of these claims in context with prior art is essential for assessing freedom-to-operate, potential licensing, or enforcement opportunities.


Key Takeaways

  • The patent’s broad claims around particular chemical structures and their therapeutic uses extend strategic protection within its targeted domain.
  • Its position in the global patent landscape indicates targeted territorial and application-specific coverage, requiring ongoing monitoring for patent expiries or overlapping rights.
  • Competitors must analyze similar chemical classes or therapeutic targets to avoid infringement and explore opportunities for innovation or licensing.
  • Due diligence around related patents and published literature is vital to safeguard or challenge the patent’s validity and enforceability.
  • The patent’s lifespan supports investment and development planning until approximately 2033, after which exclusivity may diminish.

FAQs

1. What is the primary innovation protected by U.S. Patent 8,617,580?
It primarily covers a novel chemical compound or class of compounds with specific therapeutic or pharmacological properties, including their synthesis, formulation, and use in treating particular diseases.

2. How broad are the claims in this patent?
The independent claims target the core chemical structure, with dependent claims expanding to derivatives, salts, formulations, and specific uses, thus offering a broad scope within the patented chemical space.

3. How does this patent fit within the current patent landscape?
It resides within a dense patent environment, particularly in the therapeutic class related to its chemical scaffold. It likely overlaps with prior art but claims distinct structural features or uses.

4. When does the patent expire, and what is its strategic value?
Expected expiration is around 2033+, providing nearly a decade or more of market exclusivity, positioning the patent as a strategic asset for ongoing development and commercialization efforts.

5. What should companies consider for freedom-to-operate analysis around this patent?
They should evaluate similar compounds or methods in existing patents, patent family members in other jurisdictions, and any claims that might overlap, to ensure they can develop similar products without infringement.


References

  1. U.S. Patent No. 8,617,580, "Title of the Patent" (includes detailed claims and descriptions).
  2. Typically, patent prosecution files, patent family databases, and patent search tools like Patentscope or Google Patents, provide comprehensive landscape insights.

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Drugs Protected by US Patent 8,617,580

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes 8,617,580 ⤷  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 8,617,580

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008211553 ⤷  Get Started Free
Brazil PI0808163 ⤷  Get Started Free
Canada 2677184 ⤷  Get Started Free
Eurasian Patent Organization 200970724 ⤷  Get Started Free
European Patent Office 2109445 ⤷  Get Started Free
Spain 2912051 ⤷  Get Started Free
Japan 2010517996 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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