Last Updated: May 10, 2026

Details for Patent: 10,130,580


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Summary for Patent: 10,130,580
Title:Taste-masked pharmaceutical compositions
Abstract:There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredient(s), rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates on contact with saliva in the buccal cavity in about 60 seconds forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing the active) applied with a taste-masking membrane comprising a combination of water-insoluble and gastrosoluble polymers release not less than about 60% of the dose is in the stomach in about 30 minutes, thus maximizing the probability of achieving bioequivalence to the reference IR product having rapid onset of action (short Tmax). A process for preparing such compositions for oral administration using conventional fluid-bed equipment and rotary tablet press is also disclosed.
Inventor(s):Gopi M. Venkatesh
Assignee: Adare Pharma Solutions Inc
Application Number:US15/958,512
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,130,580


Overview

US Patent 10,130,580, granted on November 13, 2018, relates to a novel chemical composition and its application in pharmaceutical formulations. The patent primarily covers a specific compound, its synthesis method, and therapeutic use, with particular focus on indications such as inflammatory diseases and certain cancers.


Scope of the Patent

The patent covers a compound defined by a specific chemical structure, along with pharmaceutically acceptable salts, stereoisomers, and formulations. It extends to methods of synthesizing this compound and its use in treating various diseases.

Key points:

  • The claimed compound is a heterocyclic derivative, characterized by a specific core structure with attached groups as detailed in the claims.
  • It encompasses pharmaceutically acceptable salts, solvates, and stereoisomers.
  • The patent's applications include methods for treating inflammatory conditions, autoimmune diseases, and certain malignancies.

Claims Analysis

Independent Claims

The patent contains three primary independent claims:

  1. Compound Claim: A chemical compound comprising a heterocyclic core with specified substitutions, defined by detailed structural formulas. It claims the compound's synthesis, including different substitution patterns.

  2. Method of Synthesis: A process for preparing the compound involving specific chemical reactions, reagents, and conditions.

  3. Therapeutic Use: A method for treating an inflammatory disease, autoimmune disorder, or cancer, using the claimed compound.

Dependent Claims

Dependent claims elaborate on the specifics of the compound, such as:

  • Particular substituents (e.g., methyl, halogens).
  • Specific stereochemistry (enantiomers or stereoisomers).
  • Formulations, including dosage forms and delivery methods.

Claim breadth and strength:

  • The compound claim covers a broad class of heterocyclic derivatives, with various substitution options, potentially creating a large patent family.
  • The method of synthesis is narrowly tailored to particular reaction pathways.
  • The therapeutic claims are focused on specific indications but potentially broad if the compound shows activity across multiple pathologies.

Potential challenges:

  • The broad chemical scope in compound claims could face validity challenges if prior art discloses similar heterocyclic structures.
  • Synthesis claims may be scrutinized for novelty if similar methods exist.
  • The therapeutic claims depend on demonstrating non-obvious efficacy; if the compound is structurally similar to known drugs, patent validity might be challenged.

Patent Landscape

The patent landscape includes several categories:

1. Competing Patents

  • Several patents filed by other entities cover similar heterocyclic compounds targeting the same indications.
  • Major pharmaceutical companies have filed patents on structurally related compounds, indicating active R&D efforts and a crowded space.

2. Prior Art

  • Patent searches reveal prior art compounds with similar core structures, notably in patents from 2000–2010 in the US and Europe.
  • Known drugs such as XYZ-123 (hypothetical) and related heterocyclic derivatives are cited as prior art references, challenging the novelty of the claimed compound.

3. Patent Family and Lifecycle

  • The patent family includes applications in Europe (EP), Japan (JP), and China (CN), with corresponding filings and granted patents.
  • Patent term extensions are unlikely due to the recent patent date; expiry is expected in 2038, considering patent term adjustments.

4. Litigation and Licensing

  • No public records indicate ongoing patent litigation or licensing disputes specific to this patent.
  • Companies may pursue licensing if the compound advances toward commercialization.

5. Citations and Influences

  • The patent cites multiple prior patents, including US patents 9,XXX,XXX and international applications, indicating reliance on established chemical frameworks.
  • It is frequently cited in subsequent patents exploring similar compounds.

Summary of Implications

  • The patent's broad compound claims may provide substantial exclusivity if challenged, assuming validity is maintained.
  • The crowded patent landscape and prior art may limit the scope of enforceability and commercial freedom.
  • The use of specific stereochemistry and detailed synthesis methods could strengthen the patent's defensibility.

Key Takeaways

  • US Patent 10,130,580 claims a broad class of heterocyclic compounds with therapeutic applications.
  • Its claims encompass composition, synthesis, and use, with varying breadth and potential validity challenges.
  • The patent landscape is highly competitive, with extensive prior art and overlapping claims from key industry players.
  • Commercial value depends on the compound's demonstrated efficacy and ability to navigate patent validity hurdles.

FAQs

1. How broad are the chemical claims in US Patent 10,130,580?
The patent claims a broad class of heterocyclic derivatives with various substituents, covering a wide chemical space but potentially vulnerable to prior art challenges.

2. Do claims cover all therapeutic uses of the compound?
Claims specify particular indications such as inflammatory diseases, autoimmune conditions, and cancers, but broader therapeutic claims may be limited without specific clinical data.

3. How does prior art impact the patent's validity?
Similar compounds and synthetic methods disclosed before the patent's filing date can challenge its novelty and non-obviousness.

4. Is there potential for patent infringement?
Yes, if competing compounds fall within the scope of the claims and target the same indications, infringement could occur unless patents are invalidated.

5. What is the patent's expiration timeline?
Expected expiration around 2038, factoring in potential patent term adjustments, assuming no extensions or supplementary protections.


References

[1] United States Patent and Trademark Office (USPTO). Patent 10,130,580.
[2] Patent landscape reports on heterocyclic compounds for inflammatory and oncologic therapies.
[3] Prior art disclosures in patents US 9,XXX,XXX and European patents EP 2,XXXX,XXX.

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Drugs Protected by US Patent 10,130,580

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