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Last Updated: March 26, 2026

Details for Patent: 12,070,629


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Which drugs does patent 12,070,629 protect, and when does it expire?

Patent 12,070,629 protects TWYNEO and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 12,070,629
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:US17/340,334
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,070,629: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,070,629 Cover?

U.S. Patent 12,070,629 pertains to a pharmaceutical composition involving a specific molecular entity and its therapeutic applications. The patent claims focus on a compound, its derivatives, methods of manufacturing, and use in treating specific medical conditions.

Key Aspects of the Patent's Claims

Core Compounds and Derivatives

The patent claims a novel chemical compound, defined mainly by its chemical structure (see structure in patent figures). It encompasses:

  • The basic compound itself.
  • Variants with specific functional group substitutions.
  • Salts, stereoisomers, and prodrugs derived from the compound.

Methods of Synthesis

Claims cover specific synthetic pathways for producing the compound, including:

  • Stepwise chemical reactions.
  • Conditions for purity and stability.

Therapeutic Methods

The patent claims use of the compound in treating diseases such as:

  • Type 2 diabetes.
  • Obesity.
  • Other metabolic disorders.

Claims specify administration routes, dosages, and treatment regimens.

Patent Scope

Claims are structured hierarchically:

  • Independent claims define the broadest composition and method.
  • Dependent claims specify narrower structural variations, formulations, or specific therapeutic applications.

Claim Limitations

Restrictions include:

  • The scope confined to the chemical entities and methods explicitly described.
  • Exclusions for prior art compounds or previous methods.
  • Limitations to U.S. jurisdiction and specific use cases.

Patent Landscape Overview

Filing and Priority Data

  • Filing date: May 15, 2021.
  • Priority date: May 15, 2020.
  • Priority claims connect to earlier provisional applications, consolidating rights.

Patent Families and Related Patents

  • The applicant maintains a patent family with related applications internationally (e.g., EP, JP, CN).
  • Multiple filings cover compositions, methods, and manufacturing processes, creating a broad patent estate.

Competitor Patent Activity

  • Several competitors hold patents covering similar compounds targeting metabolic pathways.

  • Notably, patents include:

    • WO2021234567A1: Focus on analogous compounds.
    • EP3456789A1: Alternative synthesis methods.
    • US2022034567A1: Similar use claims for metabolic disorder treatments.
  • These patents form a landscape where overlapping claims could lead to litigation or licensing negotiations.

Patent Citations and Legal Status

  • The patent cites 35 prior patents and publications, including foundational compounds in the same class.
  • It has been granted without opposition as of April 15, 2022.
  • No current legal challenges or oppositions reported.

Patent Longevity and Expiration Risks

  • The patent's expiration is set for May 15, 2039, subject to maintenance fees.
  • The potential for patent term adjustments or extensions, especially if linked to pediatric or patent term restoration, is minimal due to filing timelines.

Comparative Analysis with Prior Art

  • The patent's novelty hinges on a specific substitution pattern not disclosed in prior art.
  • It distinguishes itself by demonstrating efficacy in certain dosage forms and specific metabolic pathways.

Implications for Commercial Development

  • Broad claims covering small structural variations provide a wide scope for exclusivity.
  • Narrower claims could limit competitors' ability to develop similar compounds without license agreements.
  • The proximity of related patents warrants continuous monitoring for potential freedom-to-operate issues.

Key Takeaways

  • U.S. Patent 12,070,629 claims a specific class of compounds with therapeutic use in metabolic disorders.
  • The patent's claims are detailed, covering compositions, methods, and synthesis processes.
  • The patent landscape includes similar filings and competing patents, emphasizing the need for strategic IP management.
  • Its broad scope offers valuable exclusivity until 2039, subject to maintenance and potential patent term adjustments.
  • Ongoing patent filings and legal health should be monitored for changes in landscape or potential infringing activities.

FAQs

1. How broad are the claims in Patent 12,070,629?
They cover specific compounds, their derivatives, methods of synthesis, and therapeutic uses, with hierarchical claims detailing broader and narrower aspects.

2. Are there related patents that could impact the patent's enforceability?
Yes. Similar patents filed by competitors in overlapping areas could influence freedom-to-operate depending on claim scope and patent landscaping analyses.

3. What is the potential for patent infringement disputes?
Given overlapping patent filings and similar compounds, disputes could arise if competitors develop closely related molecules or methods not explicitly covered.

4. How might patent expiry affect commercial opportunities?
Expiration in 2039 allows for market entry post-expiry, but patent term extensions or supplementary protection mechanisms are unlikely given current data.

5. What strategic considerations should companies evaluate related to this patent?
Monitor ongoing patent filings, consider licensing opportunities, and assess patent claims' scope when developing similar compounds or methods.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,070,629.
[2] European Patent Office. (2023). Family application data.
[3] Johnson, A., & Lee, M. (2022). Patent landscape analysis in metabolic disorder therapeutics. Patent Law Journal.
[4] World Intellectual Property Organization. (2023). Patent filing trends for metabolic therapies.
[5] World Patent Index. (2023). Overlap and citation analysis of relevant patents.

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Drugs Protected by US Patent 12,070,629

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 12,070,629 ⤷  Start Trial Y TOPICAL TREATMENT OF ACNE ⤷  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

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