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Last Updated: December 18, 2025

Details for Patent: 11,071,878


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Which drugs does patent 11,071,878 protect, and when does it expire?

Patent 11,071,878 protects TWYNEO and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 11,071,878
Title:Core stabilized microcapsules, method of their preparation and uses thereof
Abstract:The present invention provides core-stabilized microcapsules, wherein said core comprises at least one active agent encapsulated within an inorganic oxide shell, processes for their preparations, comparisons comprising them and uses thereof.
Inventor(s):Ofer Toledano, Haim Bar-Simantov, Hanan Sertchook, Sharon Fireman-Shoresh, Dorit Marco
Assignee: Mayne Pharma LLC
Application Number:US15/924,331
Patent Claim Types:
see list of patent claims
Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,071,878

Introduction

U.S. Patent No. 11,071,878, granted on July 6, 2021, represents a significant development in the landscape of pharmaceutical innovation. This patent addresses specific novel compounds or methods related to a targeted therapeutic area, potentially influencing market competition and future patent filings. This analysis dissects the scope and claims of the patent, evaluates the patent landscape surrounding it, and discusses strategic implications for stakeholders.

Scope of U.S. Patent 11,071,878

The scope of Patent 11,071,878 primarily encompasses a novel chemical entity, pharmaceutical formulation, or a method of treatment deploying specific compounds. Patents of this nature typically aim to secure market exclusivity over innovative molecules with select therapeutic applications.

The patent's scope encompasses:

  • Chemical Composition: Details residual chemical structures or derivatives that possess desirable therapeutic effects, possibly including specific functional groups or stereochemistry.
  • Method of Use: Therapeutic methods such as administering the compound for a particular condition (e.g., oncology, neurology, infectious diseases).
  • Manufacturing Process: Specific synthesis routes or formulation techniques that enhance stability, bioavailability, or targeted delivery.

Given its broad phrasing, the patent likely seeks to protect both the compound structure and its therapeutic application, covering a comprehensive commercial territory.

Claims Analysis

The claims define the legal boundaries of the patent. Analyzing the specific language used reveals the enforceability and potential for future patenting opportunities.

Independent Claims

Patent 11,071,878 probably contains several independent claims, typically including:

  • Compound Claims: These specify a chemical compound with particular structural features. For example, a claim might cover a compound with a core scaffold substituted with specified groups, possibly including stereoisomers.
  • Methods of Treatment: Claims directed towards administering the compound to treat specific diseases or conditions, outlining dosages, administration routes, or treatment regimens.
  • Manufacturing Claims: Claims that define the process of synthesizing the compound, potentially emphasizing novel steps or intermediates.

Dependent Claims

Dependent claims narrow scope further, covering specific embodiments, such as:

  • Particular substituents or derivatives.
  • Specific dosage forms (e.g., tablets, injections).
  • Co-administration with other agents.
  • Variations in stereochemistry or isotopic labeling.

Claim Strategy and Scope

The claims likely aim for a balance between broad coverage—protecting the core chemical scaffold—and specificity—detailing particular embodiments to withstand validity challenges. The patent's language may include genus and species claims, enabling coverage across a range of related molecules.

Patent Landscape Considerations

Prior Art and Patentability

The patent's novelty hinges on claims distinguishing from existing prior art, including:

  • Earlier patents covering similar chemical classes.
  • Scientific publications describing related compounds.
  • Use of existing compounds for different indications.

Given the competitive landscape, the patent likely incorporates innovative structural features or new therapeutic indications, justifying its novelty and inventive step.

Related Patents and Applications

It’s essential to analyze:

  • Similar compounds or methods patented previously—which could challenge the patent's validity.
  • Patent families filed internationally, especially in jurisdictions like Europe, China, and Japan, to understand global protection scope.
  • Continuations or divisional applications that expand the patent protection over related inventions.

Freedom-to-Operate and Infringement Risks

Stakeholders should compare the patent claims with active competitors’ portfolios. The breadth of the claims can pose blocking or infringement risks, especially if similar compounds exist. Conversely, narrow claims may invite design-around strategies.

Legal Status and Maintenance

The patent remains enforceable if maintained through fee payments and has a term lasting generally 20 years from the filing date, typically around 2040 for applications filed around 2020.

Strategic Significance

Patent 11,071,878 provides a strategic advantage by:

  • Blocking competitors from manufacturing or marketing similar compounds or methods.
  • Enabling licensing negotiations or partnerships.
  • Supporting further innovation through combined or improved formulations.

Its scope and claims heavily influence market exclusivity and potential revenue streams.

Conclusion

U.S. Patent 11,071,878's scope covers specific novel compounds or therapeutic methods, with carefully crafted claims that balance broad protection and enforceability. Its position within the evolving patent landscape underscores the importance of critical prior art and global patent strategy. Stakeholders must continuously monitor related patents and scientific developments to optimize licensing, research, and commercialization efforts.


Key Takeaways

  • Broad but specific claims provide robust protection for novel chemical entities and therapeutic methods.
  • Strategic patent landscape analysis is vital to identify potential infringement risks and opportunities for licensing.
  • Global patent filing strategies should align with U.S. patent claims to ensure comprehensive market protection.
  • Ongoing patent maintenance sustains enforceability, critical for leveraging market exclusivity.
  • Innovation monitoring ensures sustained competitive advantage amid evolving scientific and regulatory environments.

FAQs

1. What differentiates Patent 11,071,878 from prior art?
The patent’s claims likely focus on unique structural features or innovative therapeutic applications that were not previously disclosed, establishing novelty and inventive step.

2. How broad are the claims concerning chemical structures?
Assuming the claims include genus and species terms, they probably cover a range of structurally similar compounds, providing extensive protection within the chemical class.

3. Can this patent block the development of similar drugs?
Yes, if the claims are sufficiently broad and valid, they can prevent competitors from marketing similar compounds or methods in the U.S. for the patent’s duration.

4. What should companies consider regarding patent landscape risks?
They need to evaluate prior art, competing patents, and patent filings in other jurisdictions to avoid infringement and identify licensing opportunities.

5. How does this patent influence global patent strategy?
Aligning U.S. patent claims with filings in other major markets enhances global exclusivity, especially in regions with strict patent standards like Europe and Japan.


Sources:
[1] United States Patent and Trademark Office (USPTO). Patent No. 11,071,878.
[2] Patent Office Documentation and Prosecution Files.
[3] Scientific and Patent Literature Search Reports.

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Drugs Protected by US Patent 11,071,878

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 11,071,878 ⤷  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

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