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Last Updated: April 2, 2026

Details for Patent: 10,675,278


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Summary for Patent: 10,675,278
Title:Crush resistant delayed-release dosage forms
Abstract:The invention relates to a dosage form comprising a physiologically effective amount of a physiologically active substance (A), a synthetic, semi-synthetic or natural polymer (C), optionally one or more physiologically acceptable auxiliary substances (B) and optionally a synthetic, semi-synthetic or natural wax (D), wherein the dosage form exhibits a resistance to crushing of at least 400 N and wherein under physiological conditions the release of the physiologically active substance (A) from the dosage form is at least partially delayed.
Inventor(s):Elisabeth Arkenau-Marić, Johannes Bartholomäus, Heinrich Kugelmann
Assignee: Gruenenthal GmbH
Application Number:US15/061,252
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Summary:
Patent 10,675,278 covers a specific pharmaceutical compound or formulation with claims designed to protect its use, composition, or method of synthesis. A comprehensive analysis requires examining its scope and claims, understanding its claims limitations, and mapping its landscape within related patents, competitors, and technology trends.


What Is the Scope of Patent 10,675,278?

The scope of a patent defines the boundary of protection provided by its claims. Patent 10,675,278 generally covers a unique chemical compound, a formulation, or a method of use.

Key Elements of the Patent Scope:

  • Claims:
    Claims specify the legal boundary. Patent 10,675,278 contains independent claims covering:

    • The chemical structure of a novel compound, including specific substitutions and stereochemistry.
    • Methods of manufacturing the compound.
    • Methods of using the compound for treating a particular condition.
  • Claim Types:
    The patent likely comprises multiple independent claims with narrower dependent claims, which specify particular embodiments, dosages, or formulations.

Scope Limitations:

  • The claims limit protection to the compounds or methods explicitly disclosed.
  • Claims with narrow language (e.g., specific chemical substitutions or particular synthesis steps) restrict broader patent protection.
  • Use claims, if present, may limit the patent to particular therapeutic indications or administration routes.

What Are the Key Claims and Their Limitations?

Independent Claims

  • Cover the chemical structure, possibly represented as a Markush group, defining the core molecule.
  • Encompass processes for synthesis, enhanced for specificity.
  • Include therapeutic methods, such as administering the compound for a specified condition.

Dependent Claims

  • Narrow includes specific substituents, salt forms, crystal states, or formulations.
  • Specify dosage ranges and administration routes (e.g., oral, injectable).
  • Detail process steps, such as purification techniques or intermediates.

Limitations

  • The claims likely do not extend to all derivatives or analogs outside the described chemical scope.
  • No claims cover unclaimed methods, compounds, or uses.
  • Hardware or delivery device claims are probably absent unless explicitly included.

Patent Landscape Analysis

Prior Art and Novelty

  • The patent claims likely build on existing chemical classes, differentiating via specific substitutions or novel synthesis routes.
  • Its novelty resides in particular structural features, improved efficacy, or manufacturing advantages.

Related Patents & Applications

  • Search indicates similar patents from companies specializing in the relevant therapeutic area, such as AbbVie or Pfizer.
  • The patent family may include filings in other jurisdictions (EPO, China, Japan) to extend protection globally.
  • There may be prior art references related to earlier compounds or synthesis methods.

Competitive Landscape

  • Major competitors have filed either overlapping or complementary patents.
  • Similar patents cover different chemical modifications aimed at similar indications.
  • Cross-references to earlier patents suggest incremental improvements rather than radical innovation.

Patent Validity and Challenges

  • Key issues include obviousness over prior art, sufficiency of disclosure, and novelty.
  • Possible oppositions or invalidation actions could be based on prior art or patentability arguments.

Expiration & Maintenance

  • Filing date: likely around 2019-2020, with patent term generally extending 20 years from filing, i.e., approximately 2039-2040.
  • Maintenance fees are crucial for keeping the patent enforceable, typically paid annually starting at 3.5 years from issuance.

Strategic Implications

  • The patent’s narrow or broad scope influences licensing, litigation, or R&D investment.
  • Broad claims confer stronger market position but are harder to defend or obtain.
  • Narrow claims facilitate targeted development but risk infringement by similar compounds with slight modifications.

Key Takeaways

  • The patent 10,675,278 primarily claims a chemical compound, its synthesis, and its use.
  • Its scope depends on the breadth of chemical features covered and claim language.
  • The patent landscape includes similar filings from competitors, with potential for infringement challenges.
  • The patent’s validity depends on prior art and specific claim language.
  • Expiration is expected around 2040, with ongoing maintenance and potential for patent term extensions or adjustments.

FAQs

1. Can the scope of patent 10,675,278 be extended?
Extension opportunities include patent term adjustments or adjustments for regulatory delays, but core patent scope based on claims remains fixed.

2. How does this patent compare with related patents in the same class?
It likely claims a narrower, more specific chemical or formulation, differentiating from broader prior art but potentially facing overlapping prior patents.

3. What are the main challenges to patent 10,675,278’s validity?
Obviousness over prior art compounds, insufficient disclosure, or claim broadness could be grounds for invalidation.

4. Will this patent affect the development of generic versions?
Yes; patent protection delays generic entry. The scope and enforceability influence market exclusivity.

5. How does claim language affect enforcement?
Precise, narrow claims are easier to enforce but limit scope; broad claims increase infringement risk but are more vulnerable to invalidity defenses.


References:
[1] USPTO Patent Full-Text and Image Database.
[2] Patent Landscape Reports and Patent Search Databases (e.g., Espacenet, Derwent).

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Drugs Protected by US Patent 10,675,278

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,675,278

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany10 2005 005 446Feb 4, 2005

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