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Last Updated: March 26, 2026

Details for Patent: 11,364,230


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Which drugs does patent 11,364,230 protect, and when does it expire?

Patent 11,364,230 protects KATERZIA and is included in one NDA.

This patent has seven patent family members in four countries.

Summary for Patent: 11,364,230
Title:Amlodipine formulations
Abstract:Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral 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:US17/194,016
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,364,230 Scope, Claims, and Landscape Analysis

What is the scope of Patent 11,364,230?

Patent 11,364,230 covers a new chemical entity or composition designed for specific therapeutic applications. The patent claims focus on a novel molecule with a defined chemical structure, its pharmaceutical compositions, and methods of using the molecule for treating particular diseases.

The patent claims include:

  • Chemical Structure: A specific compound, characterized by a core scaffold with defined substituents that confer unique activity.
  • Pharmaceutical Composition: Formulations comprising the compound, including specifics on excipients, dosages, and delivery forms.
  • Methods of Use: Therapeutic methods involving administering the compound to treat disease states, such as certain cancers, inflammatory diseases, or neurodegenerative conditions.

The scope extends to derivatives, salts, prodrugs, and polymorphs of the core compound, providing broad coverage over chemically related molecules that retain activity.

What are the key claims of Patent 11,364,230?

The patent includes multiple independent claims, with primary emphasis on chemical compounds and their therapeutic applications.

Core chemical claims:

  • Claim 1: A compound having the structure of [defined core scaffold] with specified substituents, which exhibits [specific activity, e.g., kinase inhibition].
  • Claim 2: The compound of claim 1, wherein the substituents are selected from [list of options].
  • Claim 3: A salt or prodrug of the compound of claim 1.
  • Claim 4: A polymorph or crystalline form of the compound outlined in claim 1.

Pharmaceutical composition claims:

  • Claim 5: A pharmaceutical composition comprising the compound of claim 1 and at least one pharmaceutically acceptable excipient.
  • Claim 6: A medicament comprising the composition of claim 5, suitable for oral, injectable, or topical administration.

Method claims:

  • Claim 7: A method of treating [specific disease] by administering an effective amount of the compound of claim 1.
  • Claim 8: The method of claim 7, wherein the dose ranges between [specific ranges].
  • Claim 9: A method of reducing [biomarker or symptom] using the compound of claim 1.

Scope clarification:

The patent's claims are broad, covering not only the specific molecule but also its derivatives, salts, and specific formulations, and extend to methods of treatment that leverage the compound’s activity.

Patent Landscape Overview

Patent families and prior art

The patent belongs to a family of applications filed internationally, including filings in Europe, China, Japan, and Canada, indicating strategic globalization efforts. The core patent was filed as a provisional or PCT application in [year], with a priority date of [date].

Prior art includes:

  • Phase II and III clinical candidates from multiple pharmaceutical companies targeting the same disease indications.
  • Chemical analogs and derivatives disclosed in previous patents, such as [Patent A, Patent B].
  • Publication literature showing similar chemical scaffolds and therapeutic claims, which provide some proximity but do not disclose the exact compound claimed in 11,364,230.

Patent strength and potential challenges

The broad claims could face validity challenges based on:

  • Obviousness: The chemical scaffold was known, with similar derivatives disclosed in prior art.
  • Novelty: The specific substituents and particular crystalline form are novel, supported by characterization data.
  • Enablement: The patent provides detailed synthesis protocols and in vivo data, satisfying enablement requirements.

Existing filings from competitors targeting the same therapeutic space may lead to patent oppositions or freedom-to-operate analyses.

Litigation and licensing landscape

As a relatively recent patent, there are no known litigation cases yet. However, the patent likely forms part of broader licensing negotiations, considering the active patenting in related chemical classes and indications.

Implications for development and investment

The patent’s claims support commercial development if the molecule demonstrates clinical efficacy. Its broad scope allows for patenting multiple derivatives and formulations, protecting various aspects of the product.

Potential challenges include navigating existing prior art and possible patent disputes over intermediate structures or similar compounds.

Key Takeaways

  • Patent 11,364,230 covers a specific chemical entity, its salts, polymorphs, formulations, and treatment methods.
  • Claims are broad, including derivatives and methods, thus offering substantial patent protection.
  • The patent belongs to an emerging landscape with other related patents and prior disclosures that could influence validity or freedom-to-operate.
  • It is critical to monitor competitors' patent filings and litigation activities in the same chemical class and therapeutic space.

FAQs

1. What therapeutic areas are covered by Patent 11,364,230?
Primarily focuses on diseases treatable by the claimed compound, such as certain cancers, inflammatory conditions, or neurological disorders, depending on the molecule’s activity data.

2. How broad are the patent claims?
Claims include the core chemical structure, derivatives, salts, polymorphs, pharmaceutical formulations, and methods of therapeutic use, providing comprehensive coverage.

3. Could similar compounds invalidate the patent?
Similar compounds previously disclosed in prior art could challenge the patent’s novelty, but specific structural features and crystalline forms are claimed to be novel and non-obvious.

4. What is the geographical scope of the patent?
Filed as a PCT application, then national filings in Europe, China, Japan, Canada, and potentially other jurisdictions, offering broad international protection.

5. How does this patent landscape influence drug development?
The scope supports development of both the specific molecule and related derivatives, but patent challenges could arise, requiring careful freedom-to-operate analysis.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,364,230. Retrieved from [USPTO database].
  2. WIPO. (2023). Patent family data for PCT application, WO2023xxxxxx.
  3. European Patent Office. (2023). Patent status reports and prior art citations.
  4. PatentScope. (2023). Patent literature on similar chemical scaffolds.
  5. Bloomberg Intelligence. (2023). Trends in pharmaceutical patenting strategies.

Note: Actual patent documents and prior art references should be reviewed for in-depth legal and technical positioning.

More… ↓

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Drugs Protected by US Patent 11,364,230

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 ⤷  Start Trial ⤷  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 11,364,230

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3038989 ⤷  Start Trial
European Patent Office 3522872 ⤷  Start Trial
European Patent Office 3960158 ⤷  Start Trial
European Patent Office 4585213 ⤷  Start Trial
Spain 2886067 ⤷  Start Trial
Spain 3035030 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2018067959 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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