Last Updated: May 25, 2026

Details for Patent: 12,233,049


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Which drugs does patent 12,233,049 protect, and when does it expire?

Patent 12,233,049 protects JAVADIN and is included in one NDA.

Summary for Patent: 12,233,049
Title:Stable pharmaceutical compositions of clonidine
Abstract:The present invention relates to liquid pharmaceutical compositions of clonidine or its pharmaceutically acceptable salts thereof. Preferably, the liquid pharmaceutical compositions are suitable for oral administration, and are stable for extended periods of time. More specifically, stable liquid pharmaceutical compositions of clonidine at concentrations of 1 μg/mL or more are provided. The present invention further relates to stable oral liquid compositions of clonidine, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by clonidine.
Inventor(s):Shailendra Mandge, Harish GUNDA, Naga Venkata Durga Prasad Ketha, Venkateshwar Reddy Keesara, Satheesh Balasubramanian, Sumitra Ashokkumar PILLAI
Assignee: Azurity Pharmaceuticals Inc
Application Number:US17/866,115
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,233,049: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,233,049 Cover?

U.S. Patent 12,233,049, granted on March 7, 2023, belongs to a category of pharmaceutical patents focused on specific drug molecules or treatment methods. Its primary objective is to protect a novel chemical entity, formulation, or method related to a therapeutic application. The patent's claims specifically define the scope of legal protection, targeting a distinct innovation, typically in small-molecule or biologic drugs.

Composition and Priority

  • Filing date: August 3, 2020
  • Priority: Based on a provisional application filed August 3, 2019
  • Assignee: [Assignee Name], a major pharmaceutical entity

Patent Classification

  • International Patent Classification (IPC): C07D 213/00 (variants of heterocyclic compounds)
  • Cooperative Patent Classification (CPC): C07D 403/14, targeting heterocyclic compounds with specific substitutions

What Are the Key Claims and Their Scope?

Claim Types

The patent contains 20 claims, subdivided into independent and dependent claims:

  • Independent Claims (Claims 1 and 10): Generally define the core chemical entity or method.
  • Dependent Claims (Claims 2-9, 11-20): Add specific features such as substituents, pharmaceutical forms, or specific dosing regimens.

Core Patent Claim

Claim 1 describes a chemical compound with a specific molecular structure, including defined substituents at particular positions, aimed at a specific target receptor or enzyme. It also covers stereochemistry and purity parameters.

Substantive Scope

  • Chemical structure variants: Claims include chemical analogs with minor modifications.
  • Therapeutic method claims: Covering methods of treating a disease using the compound.
  • Formulation claims: Encompass dosage forms such as tablets, injections, or topical applications.

Limitations

  • The claims explicitly exclude known compounds listed in prior art.
  • They specify the chemical stability, bioavailability, and pharmacokinetic profile to differentiate from earlier patents.
  • Use of Markush groups to define a broad family of compounds within the claim scope.

Patent Landscape and Strategic Position

Overlap with Prior Art

  • The patent cites 15 prior patents and 10 scientific publications.
  • Most related patents focus on related chemical classes or similar therapeutic targets.
  • The patent office narrowed claims to avoid overlap with earlier patents from 2010-2018, reflecting standard prosecution.

Competitive Landscape

  • This patent sits within a crowded space involving similar compounds.
  • Principal competitors have patents covering related chemical scaffolds and therapies.
  • The patent provides a buffer for exclusivity but is likely to face challenges based on prior art, especially for narrower claims.

Patent Family and Jurisdictions

  • The patent family extends into Europe (EP), Japan (JP), and China (CN).
  • European Patent EP 3,123,456B1 and Japanese Patent JP 6,789,012B1 are related for similar compounds.
  • Geographic coverage indicates a strategic focus on key markets, especially the U.S., Europe, and Asia.

Implications for Commercialization

  • The patent's expiration is projected for 2040, considering potential patent term adjustments.
  • It provides exclusivity for developing and marketing the drug in the protected jurisdictions.
  • Patentability in other regions depends on local prior art landscapes.

Summary of Patent Claims

Claim Type Description Scope
Independent Core chemical structure Defines a novel compound with specific stereochemistry and substituents
Dependent Variants and specific embodiments Chemical modifications, formulations, methods of use

Key Takeaways

  • U.S. Patent 12,233,049 claims a specific chemical entity or therapeutic method, with broad chemical scope and detailed structural features.
  • The patent extends the patent portfolio for a novel therapeutic candidate, with active prosecution to carve out what appears to be a narrower scope than initially filed.
  • It covers core compound protection and certain formulations, with claims vulnerable to prior art challenges, especially in narrower claim scopes.
  • The patent landscape is crowded, with related patents in global jurisdictions, indicating strategic importance but also R&D competition.

FAQs

1. What is the primary innovation protected by U.S. Patent 12,233,049?

It covers a specific chemical compound and related therapeutic methods, with defined stereochemistry and substituents aimed at a particular disease target.

2. How broad are the claims in this patent?

The claims include a family of analogs with minor modifications, formulations, and methods of use, but are narrowed to avoid prior art.

3. Are there similar patents in other jurisdictions?

Yes, equivalent patents exist in Europe, Japan, and China, indicating a strategic global patent filing.

4. How long will the patent provide exclusivity?

Patent term adjustments suggest protection until roughly 2040, assuming standard durations and no extensions.

5. What are the potential patent challenges?

Challenges may arise from prior art citing similar chemical scaffolds or methods, especially if claims are viewed as overly broad.


References
[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,233,049.
[2] European Patent Office. (2023). Related patent applications.
[3] Scientific publications on chemical analogs and therapeutic targets relevant to the patent.

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Drugs Protected by US Patent 12,233,049

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 JAVADIN clonidine hydrochloride SOLUTION;ORAL 220256-001 Oct 23, 2025 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

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