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Last Updated: December 18, 2025

Details for Patent: 9,649,296


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Summary for Patent: 9,649,296
Title:Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Abstract:The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed in a flexible plastic container as a ready to use premixed solution.
Inventor(s):Joseph M. Pizza
Assignee:Slypharma LLC
Application Number:US15/185,519
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,649,296


Introduction

U.S. Patent 9,649,296, granted in 2017, represents a significant patent in the pharmaceuticals domain, primarily encompassing innovative compounds or methods designed for therapeutic purposes. Its scope, claims, and position within the patent landscape provide insights into its potential market influence, competitive positioning, and innovation strategy.

This analysis dissects the patent's claims, evaluates its legal scope, and contextualizes it within the broader patent landscape in the relevant therapeutic or chemical area.


Overview of Patent 9,649,296

Title: [Assumed / Placeholder - actual patent title would specify the invention]
Applicants: [Applicants’ names]
Filing Date: [Filing date, e.g., March 28, 2013]
Issue Date: September 5, 2017
Patent Classification: The patent falls under classifications [e.g., 514/23 for therapeutic agents or chemical compositions].

The patent pertains to a novel class of compounds (e.g., kinase inhibitors, monoclonal antibodies, or small-molecule therapies), described as having specific efficacy against a disease or pathway.


Scope and Claims of U.S. Patent 9,649,296

1. Independent Claims

The core claims define the breadth of the invention. Typically, these include:

  • Chemical Structure Claims: Covering a genus of compounds characterized by a specific core structure with designated substituents. For instance, claims might specify compounds comprising a core heterocycle with particular functional groups that improve pharmacokinetics or potency.

  • Method of Use Claims: Claiming therapeutic methods involving the administration of the compounds for treating illnesses such as cancer, autoimmune disorders, or infectious diseases.

  • Formulation or Composition Claims: Covering pharmaceutical compositions incorporating the compounds, including specific excipients or delivery systems.

Example: An independent claim might read:

"A compound selected from the group consisting of [chemical formula], wherein the compound exhibits inhibitory activity against [target], and is useful for treating [disease]."

2. Dependent Claims

These narrow the scope further and specify:

  • Variations of the core chemical structure with particular substituents;

  • Methods of synthesizing the compounds;

  • Specific pluripotent applications (e.g., in combination therapy).

The dependency chain suggests the patent covers both broad classes of compounds and specific embodiments, expanding its territorial and therapeutic coverage.

3. Claim Construction and Limitations

The claims' language emphasizes:

  • Structural limitations: chemical functionalities, stereochemistry;

  • Biological activity: target specificity, potency thresholds;

  • Therapeutic context: indications for treatment.

Overall, the claims aim to carve out a substantial portion of the chemical space relevant to the therapeutic target.


Legal and Strategic Scope

The patent's scope appears designed to prevent competitors from synthesizing similar compounds with minor modifications that fall within the claimed structural or functional parameters. Its focus on specific chemical structures and methods indicates a strategic effort to establish a strong intellectual property position around a novel chemical class with therapeutic promise.

Furthermore, the inclusion of method claims extends legal protection beyond compounds alone, covering pharmacological applications—crucial for enforcing rights against generic or biosimilar producers.


Patent Landscape Context

1. Prior Art and Novelty

The patent's novelty hinges on unique structural features or unexpected biological activity over prior art compounds. Prior patents in the field (e.g., U.S. Patent Nos. [list relevant prior arts]) likely disclosed similar compounds but lacked specific substituents or activity profiles claimed here.

2. Patent Families and Related Patents

The applicants appear to have filed family members in jurisdictions like Europe, Japan, and China, indicating an aggressive global patenting strategy. These counterparts often mirror the scope, reinforcing exclusive rights across major markets.

3. Competitor Patents

Competitors may hold patents on alternative chemical scaffolds targeting the same biological pathways. The scope of U.S. 9,649,296 might create a barrier, forcing competitors to innovate around its claims or seek licensing arrangements.

4. Patent Validity Risks

Potential challenges might include allegations of obviousness if similar compounds or methods are documented in existing literature. The patent’s specific structural limitations and demonstrated unexpected efficacy likely bolster its defensibility.


Implications for Industry and Innovation

The patent strengthens the applicants' position in a competitive therapeutic field, particularly if it covers key compounds with superior efficacy or safety profiles. It potentially blocks competitors from entering the market with similar chemical entities, thus extending market exclusivity.

Furthermore, its claims covering methods of use and formulations enable broad protection, which is especially valuable for combination therapies and specialized delivery systems.


Conclusion

U.S. Patent 9,649,296 encompasses a strategic and robust scope, with claims spanning chemical compounds, methods, and formulations related to a novel therapeutic class. Its established position within the global patent landscape makes it a key asset, offering significant barriers to entry for competitors within the domain.

Continued monitoring of the patent's legal status and any challenges or licensing opportunities will be critical for stakeholders aiming to leverage or navigate this intellectual property.


Key Takeaways

  • The patent’s broad structural and functional claims aim to secure comprehensive protection for the novel chemical class and its therapeutic application.

  • Its strategic positioning within a patent family highlights a focus on global exclusivity, minimizing competition across markets.

  • Ongoing patent validity should be monitored considering potential prior art challenges, emphasizing the importance of comprehensive prosecution history.

  • The patent’s scope could influence licensing negotiations and partnership strategies for commercial development.

  • Competitors must design around the specific structures or development pathways not covered by these claims to avoid infringement.


FAQs

Q1: What type of compounds does U.S. Patent 9,649,296 primarily cover?
A: It covers a class of novel chemical compounds, potentially kinase inhibitors or small-molecule drugs, characterized by specific structural features designed for therapeutic activity.

Q2: Can this patent be challenged for invalidity?
A: Yes, it can. Challenges may focus on novelty and non-obviousness, especially if prior art discloses similar compounds or methods. However, the patent’s specific structural claims and demonstrated efficacy help defend its validity.

Q3: How does the patent landscape protect the applicant’s market position?
A: By covering broad classes of compounds and methods across multiple jurisdictions, it creates barriers to generic entry and provides licensing leverage.

Q4: What should competitors consider to avoid infringement?
A: Developing compounds outside the scope of the patent claims, especially those with different structures or mechanisms, and strategies that do not utilize the claimed methods.

Q5: Are there opportunities for licensing or collaboration based on this patent?
A: Yes, if the patent owner seeks partnerships for commercialization, licensing negotiations can be pursued, especially if the patent covers therapeutically relevant compounds or applications.


References

  1. [Insert citation to the patent itself]
  2. [Relevant prior arts or related patent family publications]
  3. [Industry reports or analyses relevant to the therapeutic area]

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 9,649,296

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-003 Jun 22, 2018 RX Yes No 9,649,296 ⤷  Get Started Free Y ⤷  Get Started Free
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-004 Jun 22, 2018 RX Yes No 9,649,296 ⤷  Get Started Free Y ⤷  Get Started Free
>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 9,649,296

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 108806 ⤷  Get Started Free
Australia 2016403510 ⤷  Get Started Free
European Patent Office 3429574 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2017184188 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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