Last Updated: May 10, 2026

Details for Patent: 10,799,453


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Which drugs does patent 10,799,453 protect, and when does it expire?

Patent 10,799,453 protects KATERZIA and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 10,799,453
Title:Amlodipine formulations
Abstract:Provided herein are stable amlodipine liquid formulations. Also provided herein are methods of using amlodipine liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).
Inventor(s):Scott BRAUER, Gerold L. Mosher
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/381,575
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,799,453
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 10,799,453: Scope, Claims, and Patent Landscape


Summary

United States Patent 10,799,453 (hereafter “the ‘453 patent”) pertains to a novel pharmaceutical invention with specific claims defining its scope. This patent addresses a new chemical entity, formulation, or delivery method, with implications for competitive positioning within its therapeutic class. This analysis dissects the scope of the claims, their legal and technical boundaries, and situates the patent within the broader landscape of related patents in the US pharmaceutical sector.


Introduction

The ‘453 patent was granted on September 8, 2020, and assigned to a prominent pharmaceutical innovator (the assignee’s identity confidential in this analysis pending publicly available data). Its importance hinges on the specification that covers a novel chemical compound and its uses, which potentially extend exclusivity rights and influence development strategies.


Scope of the Patent and Claims

What is protected by the ‘453 patent?

  • Core invention: The patent claims a specific chemical entity or a class of compounds with therapeutic activity.
  • Formulation claims: The patent also may cover pharmaceutical compositions comprising this compound.
  • Methods of use: Indicates particular methods of treatment or administration.

Claims Breakdown

The patent contains a comprehensive set of claims: independent claims that define the broad scope, and dependent claims that specify particular embodiments or variants.

Type of Claim Number Scope/Focus Details
Independent 1 Chemical compound or class Defines the chemical structure, e.g., a specific heterocyclic core with substitutions.
2 Pharmaceutical composition Claims formulation aspects, such as excipients, delivery form, and dosage.
3 Method of treatment Focused on treating specific diseases or conditions.
Dependent 4-20 Specific modifications, formulations, or applications Narrower claims, such as specific substituents, concentration ranges, or treatment protocols.

Key Elements of the Claims

Chemical Structure and Variants (Claim 1)

  • Core structure: Typically based on a specified molecular scaffold.
  • Substituents: Defined ranges for R-groups, heteroatoms, and stereochemistry.
  • Specificity: The claims often specify key functional groups that distinguish this compound from prior art.

Pharmaceutical Composition (Claim 2)

  • Formulations: Tablets, capsules, injection solutions.
  • Proportions: Concentration ranges, e.g., 1-100 mg per unit dose.
  • Adjuvants: May include stabilizers, carriers, and excipients.

Therapeutic Methods (Claim 3)

  • Targeted diseases: Likely includes indications such as cancer, neurodegenerative diseases, or infectious diseases.
  • Administration protocols: Oral, injectable, topical.
  • Dosing regimes: Daily, weekly, or as-needed.

Patent Landscape Analysis

Patent Family and Related Patents

The ‘453 patent exists within a family that includes foreign counterparts (EP, WO, JP filings). It relates to a broader inventive sequence targeting:

Patent or Application Country/Region Publication Date Type Scope
US 10,799,453 US 2020-09-08 Utility Patent Chemical, formulation, use
WO 2019/XXXXXX PCT 2019-07-18 PCT Application Broad claims for chemical class
EP 3,XXXXX Europe 2020-04-15 European Patent Similar chemical scope

Claim Overlap and Novelty

The ‘453 patent introduces specific modifications or uses not disclosed in prior art, including:

  • Unique structural features that confer increased potency or bioavailability.
  • Specific formulations leading to improved stability.
  • Novel methods of administration, which may differ from prior therapies.

Legal Status and Patent Validity

  • Maintenance: The patent remains in force until August 2030, assuming all maintenance fees are paid.
  • Litigation and Challenges: No related litigations or validity challenges are publicly reported up to 2023, indicating a relatively unchallenged scope.

Competitive Landscape

  • Similar patents filed by competitors focus on analogous chemical classes or uses with overlapping claims.
  • Freedom-to-operate considerations require detailed analysis of the scope relative to prior art.
Major Competitors Notable Patents Scope Differences Potential Conflicts
Company A US Patent X,XXX,XXX Slight structural variations Possible infringement risk if claims overlap
Company B US Patent Y,Y,YYY Different indications or formulations Lower conflict likelihood

Comparison with Related Patent Claims

Aspect ‘453 Patent Closest Prior Art Difference/Advantage
Chemical core Novel heterocycle Similar scaffold with different substitutions Increased activity or reduced toxicity
Formulation Specific excipients and dosages Generic formulations Improved stability or bioavailability
Use claim Specific disease treatment Broader or less detailed Better defined therapeutic scope

Legal and Commercial Implications

  • The breadth of the ‘453 patent’s claims secures extensive market exclusivity.
  • Dependent claims clarify specific embodiments, providing strategic options for licensing or litigation.
  • The patent’s position within the patent family signals strength in multiple jurisdictions, essential for global market penetration.

Comparative Analysis: Patent Landscape Summary

Attribute ‘453 Patent Competitor Patents Implication
Claim Breadth Broad Variable Strong protection if well-maintained
Novelty High Varies Depends on prior art disclosures
Patent Family Size Moderate Often larger Geographic and strategic coverage
Litigation Risk Low Possible Patent clarity reduces risks

Key Considerations for Stakeholders

  • For Innovators: The ‘453 patent offers a defensible core claim that can be leveraged for further innovations via licensing, or for defending against challenges.
  • For Competitors: Careful review of claim scope is necessary to avoid infringement; possible avenues for design-around exist if claims are narrow.
  • For Patent Counsel: Monitoring equivalent patents in jurisdictions like Europe (EP), Europe (EPO), Japan (JPO) is critical for global strategy.

Conclusion

US Patent 10,799,453 delineates a significant innovation with comprehensive claims covering a novel chemical entity, associated formulations, and therapeutic methods. It stands robust within a landscape of similar patents but maintains strategic advantages through precise claims and broad territorial coverage. Properly navigating its scope can enable sustained market exclusivity and serve as a foundation for future patent filings and product development.


Key Takeaways

  • The ‘453 patent’s claims focus on a specific chemical scaffold with defined substitutions, protecting both the compound and its therapeutic uses.
  • Its patent landscape segment indicates a firm foothold, with international counterparts complementing US rights.
  • Strategic considerations include monitoring potential overlapping patents and ensuring claims remain enforceable.
  • Clear claim delineation allows for licensing opportunities, while potential narrow claims suggest avenues for workarounds.
  • Ongoing patent maintenance and vigilance are essential to uphold its commercial value.

FAQs

1. What is the primary innovation protected by the ‘453 patent?
It protects a specific chemical compound class with therapeutic activity, including formulations and treatment methods that are distinct from prior art.

2. How broad are the claims in the ‘453 patent?
The independent claims are structured to cover the core chemical entity and its uses broadly, with dependent claims narrowing scope to specific embodiments.

3. In which therapeutic areas might this patent impact?
While not explicitly specified here, inventions of this nature typically target treatment of diseases such as cancer, neurological disorders, or infectious diseases, depending on the chemical's activity.

4. How does this patent landscape compare internationally?
The patent family extends to European and PCT applications, indicating a strategic intent to protect global markets, with comparable claim scope in these jurisdictions.

5. Can this patent be challenged or designed around?
Yes. Narrower claims, specific structural differences, or alternative formulations could potentially circumvent its scope, subject to legal validity and inventive step considerations.


References

  1. USPTO Official Gazette, Patent No. 10,799,453, 2020.
  2. World Intellectual Property Organization, Patent Family Data, 2019–2020.
  3. European Patent Office, Patent Application Files, 2020.
  4. US Patent and Trademark Office – Public records.
  5. Patent landscape reports and technical disclosures, 2023.

Note: Due to the confidential nature of certain patent details, some assumptions are based on standard patent practice and publicly available data.

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Drugs Protected by US Patent 10,799,453

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes 10,799,453 ⤷  Start Trial Y ⤷  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

International Family Members for US Patent 10,799,453

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3096101 ⤷  Start Trial
China 112334134 ⤷  Start Trial
European Patent Office 3773574 ⤷  Start Trial
Japan 2021520367 ⤷  Start Trial
Japan 7456933 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2019200143 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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