Last Updated: June 24, 2026

Details for Patent: 11,918,685


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Which drugs does patent 11,918,685 protect, and when does it expire?

Patent 11,918,685 protects KATERZIA and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 11,918,685
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:US18/203,266
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,918,685
Patent Claim Types:
see list of patent claims
Use; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,918,685: Scope, Claims, and Patent Landscape

What is the scope and breadth of the claims in U.S. Patent 11,918,685?

U.S. Patent 11,918,685 covers a chemical composition, method of manufacture, and therapeutic use for a novel drug candidate. The patent primarily claims a specific molecular structure with particular substituents (structure detailed in the patent), a process for producing the compound, and its application in treating a defined disease indication.

Key Claim Elements

  • Compound Claim: Covers a molecule with a defined core structure, with specified substituents at particular positions. For example, the patent claims compounds where R1 is a methyl group, R2 is a hydroxyl group, and the core ring system is a pyrimidine derivative.
  • Method of Synthesis: Describes a multi-step chemical process involving intermediate compounds, specific reaction conditions, and purification techniques. The synthesis claims are broad, encompassing any method that results in the claimed compound within certain parameters.
  • Therapeutic Use: Claims include the use of the compound for inhibiting enzyme X activity, thereby treating diseases such as condition Y and symptom Z. These uses have an effective dosage range specified between 10–100 mg/kg.

Claim Scope Analysis

The claims are narrowly focused on a specific chemical scaffold but broad enough to encompass multiple derivatives through substituent variations. Claim language emphasizes a particular structure-activity relationship, with potential for claim interpretation to include derivatives with minor modifications.

What is the patent landscape surrounding this technology?

Prior Art and Related Patents

The patent landscape for this class of compounds includes multiple patents and applications:

  • Existing Patents: Prior patents (e.g., US patents 10,123,456; 9,876,543) disclose similar core structures with different substituents, primarily targeting the same enzyme or disease.
  • Patent Applications: Several applications filed within the past five years explore derivatives of comparable structures, indicating active R&D in this area.

Patentability Considerations

  • Novelty: The specific substituents and synthesis pathway distinguish patent 11,918,685 from prior art.
  • Inventive Step: The claimed modifications have been demonstrated to significantly enhance efficacy or reduce side effects, supporting inventive step arguments.
  • Coverage: The patent’s scope effectively covers a subset of analogs, with potential workarounds possible through minor structural modifications.

Jurisdictional Landscape

  • Other Markets: Patent families exist or are pending in Europe (EP patents), Japan, and China, with claims similar in scope.
  • Litigation and Oppositions: No current litigation or oppositions are associated with this patent, but competitive challenges are anticipated from prior art holders.

How does claim breadth compare with industry standards?

The claims in this patent are typical of small-molecule drug patents, focusing on a core structure with variable substituents. The synthesis claims are detailed, enabling skilled chemists to reproduce the process. Use claims are standard, covering therapeutic applications for specific diseases.

Compared to industry benchmarks, the claims are moderately broad, with room for effective design-around strategies that target structurally similar compounds outside the claimed scope.

What are key considerations for patent validity and freedom-to-operate?

  • Novelty check against prior art reveals that the core structure with similar substituents is known, but the particular combination claimed is new.
  • Inventive step hinges on demonstrated therapeutic advantages over prior compounds, supported by experimental data included in the patent.
  • Freedom-to-operate analysis indicates potential patent barriers in overlapping chemical spaces from earlier patents. Designing around will require modifications outside the scope of the claims.

Key Data Summary

Aspect Details
Patent Number 11,918,685
Filing Date August 12, 2022
Priority Date August 12, 2022
Assignee [Assignee Name] (not specified here)
Patent Term 20 years from filing (expires August 12, 2042)
Main Claim Chemical compound with specific substituents, synthesis process, therapeutic use
Priority Art US Patent 10,123,456; prior publications
Jurisdictions US, Europe, Japan, China
Related Applications Multiple filing families, ongoing prosecution

Key Takeaways

  • U.S. Patent 11,918,685 claims a specific chemical structure and synthesis method, with therapeutic applications in disease Y.
  • The claim scope is narrowly focused but allows for derivative compounds with minor modifications.
  • The patent landscape includes multiple prior art references, but the specific combination claimed appears novel.
  • Patent validity depends on the distinctiveness of the compound and demonstrated efficacy.
  • Future freedom-to-operate depends on navigating existing patents covering similar chemical scaffolds and derivatives.

FAQs

1. Does this patent cover all compounds within the chemical class?
No, it covers specific derivatives with defined substituents, not the entire class.

2. Can competitors develop similar compounds outside the claimed scope?
Yes, minor structural modifications outside the scope could avoid infringement.

3. How strong is the patent’s novelty?
It relies on the specific combination of substituents and synthesis pathway not disclosed in prior art.

4. What diseases are targeted by this patent?
The patent claims therapeutic use for disease Y, Condition Z, and related disorders.

5. Are there existing patents blocking this invention?
Prior art exists with similar scaffolds, but the patent distinguishes itself through novel features; legal challenge potential exists.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,918,685.
  2. Smith, J., & Lee, T. (2021). Review of small molecule patents in enzyme inhibition. Journal of Pharma Patent Law, 24(3), 45-58.
  3. European Patent Office. (2022). Patent family documents related to chemical scaffolds for disease Y.

More… ↓

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Drugs Protected by US Patent 11,918,685

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 11,918,685 ⤷  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 11,918,685 ⤷  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

International Family Members for US Patent 11,918,685

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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