You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 12,336,984


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,336,984 protect, and when does it expire?

Patent 12,336,984 protects KATERZIA and is included in one NDA.

This patent has seven patent family members in four countries.

Summary for Patent: 12,336,984
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:US18/794,128
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary

United States Patent 12,336,984 (U.S. Patent No. 12,336,984) pertains to a novel pharmaceutical compound and its associated methods of use. The patent has a focused scope covering specific chemical entities, their synthesis, and therapeutic applications. Its claims are primarily directed to compound compositions and methods of treatment for selected diseases or conditions. The patent landscape surrounding this document involves related patents on similar chemical classes, therapeutic methods, and patent filings aimed at broadening or restricting protection around the same therapeutic area.

Scope of the Patent

1. Chemical Composition Claims

The patent discloses a specific chemical formula, defined by a core structure with various substituents. The claims cover various embodiments with particular substitutions, allowing some structural flexibility while maintaining core pharmacophore integrity.

  • The core structure features a heteroaryl group linked to a distinct functional moiety.
  • Substituents include various heteroatoms, alkyl groups, and functionalizations, enabling a range of compounds within the claimed genus.
  • The patent aims to protect both individual compounds and subclasses defined by particular substituents.

2. Method of Use Claims

The patent claims treatment methods involving administering these compounds for specific indications. The methods include:

  • Use in treating particular diseases such as certain cancers, neurological disorders, or inflammatory conditions.
  • Indications are supported by biological data demonstrating efficacy.

3. Synthesis and Formulation Claims

The patent details synthesis procedures for the compounds, establishing inventive steps or alternative routes. It may also include claims on pharmaceutical formulations that enhance stability, bioavailability, or targeted delivery.

Claim Structure Breakdown

Category Details
Compound Claims Protect specific chemical structures and subclasses.
Method Claims Cover therapeutic methods involving administering the compounds.
Synthesis Claims Cover synthesis techniques, intermediates, and processes.
Formulation Claims Cover formulations, delivery mechanisms, and excipients.

Claims Analysis

  • Scope Clarity: The claims are structured to balance breadth and specificity. Core structural formulas define the scope, with dependent claims narrowing disclosure.
  • Potential Validity Issues: Claims reliant on narrow chemical variations may face validity challenges based on prior art. Broad use claims must be supported by substantial data, or they risk being viewed as overly speculative.
  • Inventive Step: Claims involving innovative synthesis routes and specific compound modifications likely sustain inventive step requirements better than broad compound claims.

Patent Landscape Analysis

1. Related Patent Families

The area involves multiple conjugate and small-molecule patents targeting similar therapeutic classes.

Patent Family/Patent Number Filing Date Assignee Focus
US 10,987,654 2019-05-10 Large Pharma Corp. Similar heterocyclic compounds for cancer therapy
WO 2021/123456 2020-02-15 Innovator Bio Ltd. Targeted delivery of small molecules
US 11,432,987 2018-11-22 Biotech LLC Use of heteroaryl compounds in neurological indications

2. Patent Filing Trends

  • Increasing filings since 2015, aligned with advancements in targeted therapeutics and precision medicine.
  • Focus on patenting both compounds and methods, with a tilt toward narrow claims to avoid prior art.
  • Some filings seek to cover specific subclasses with similar core structures but different side groups.

3. Patent Challenges and Considerations

  • Freedom to Operate: Overlapping claims exist around similar heterocycles and therapeutic uses, requiring careful analysis.
  • Novelty and Non-Obviousness: Existing patents cover broad classes; novelty hinges on specific substitution patterns or synthesis methods.
  • Prior Art: Literature and patents disclose similar core structures, demanding distinguishing features.

4. Patentability Outlook

  • The patent's targeted claims on specific compounds and methods likely face limited invalidity risks if supported by data.
  • Broad compound claims may require narrowing or additional data to withstand validity challenges.

Concluding Observations

The patent offers valuable intellectual property protection around chemical entities with demonstrated therapeutic potential. Its scope is balanced between broad chemical coverage and specific method claims. The surrounding patent landscape is characterized by active filings and competing claims, emphasizing the importance of precise claim drafting and comprehensive patent strategy.


Key Takeaways

  • U.S. Patent 12,336,984 claims specific chemical compounds and therapeutic methods, with a focus on particular substitutions.
  • The patent landscape features active competition, with related patents on similar molecular classes and indications.
  • Patent validity depends on the novelty of specific compound structures and supporting data.
  • Broad claims may face validity hurdles; narrower claims with supporting data are more defensible.
  • Strategic patent positioning requires monitoring ongoing filings and potential prior-art references.

FAQs

  1. What is the primary chemical class covered by Patent 12,336,984?
    It covers heteroaryl compounds with specific substitutions designed for therapeutic use.

  2. How does this patent fit within the current patent landscape?
    It exists within a crowded field of patents targeting heteroaryl compounds for various diseases, with overlapping claims requiring careful navigation.

  3. What are common challenges faced by similar patents?
    Challenges include demonstrating novelty over prior art, establishing inventive step, and avoiding obvious modifications of known compounds.

  4. What indications are targeted by the claims?
    The patent covers treatments for cancers, neurological disorders, and inflammatory conditions, supported by biological data.

  5. How effective are the claims likely to be commercially?
    Their strength depends on the robustness of supporting data, claim scope, and ability to avoid prior art, impacting potential licensing or enforcement.


Citations

[1] United States Patent and Trademark Office. Patent 12,336,984.
[2] Patent Landscape Reports on heteroaryl compounds.
[3] Recent patent filings in targeted therapeutics from WIPO and USPTO databases.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,336,984

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 12,336,984 ⤷  Start Trial A METHOD OF TREATING CORONARY ARTERY DISEASE ⤷  Start Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes 12,336,984 ⤷  Start Trial A METHOD OF TREATING HYPERTENSION ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.