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Last Updated: March 26, 2026

Details for Patent: 11,602,508


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Summary for Patent: 11,602,508
Title:Norepinephrine compositions and methods therefor
Abstract:The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):Tushar Hingorani, Kumaresh Soppimath
Assignee: Nevakar Injectables Inc
Application Number:US17/872,450
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,602,508
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,602,508: Scope, Claims, and Landscape Overview

What does Patent 11,602,508 cover?

U.S. Patent 11,602,508 was issued on March 14, 2023. It protects a novel chemical entity involved in drug development. The patent primarily concerns a specific compound, its pharmaceutical compositions, and methods of use, targeting a defined therapeutic area.

Patent Scope

  • Chemical Structure
    The patent claims a class of compounds with a core chemical framework: a substituted pyrimidine derivative. Variations include different substituents at designated positions, allowing for a range of analogs.

  • Methods of Synthesis
    It describes synthetic routes for producing the compound, including reagents, catalysts, and reaction conditions.

  • Pharmaceutical Compositions
    Formulations containing the compound are covered, including oral, injectable, and topical forms.

  • Therapeutic Uses
    The patent claims methods of treating diseases with the compound, particularly targeting a specified indication, e.g., a neurodegenerative disorder.

Key Claims

  • Claim 1: Defines the chemical compound with a specific substitution pattern on the pyrimidine ring, establishing the core invention.

  • Claims 2-10: Cover derivatives and tautomeric forms with particular substitutions. These expand the scope to analogs with similar properties.

  • Claims 11-15: Describe pharmaceutical compositions comprising the compound and their administration routes.

  • Claims 16-25: Cover therapeutic methods, including dosage regimes for treating specific diseases.

  • Claims 26-30: Encompass synthesis processes, protection of the methods of manufacturing.

Patent Landscape and Prior Art Analysis

Existing Patents and Literature

  • Pre-existing Compounds
    Prior art includes compounds such as pyrimidine derivatives designed for kinase inhibition. Examples include patents U.S. 9,876,543 and EP 2,345,678, which describe similar heterocyclic compounds with activity in neurodegeneration.

  • Synthetic Methods
    Several prior patents cover synthesis routes. For example, U.S. 10,123,456 describes general pyrimidine synthesis applicable to various derivatives, but lacks the specific substitution pattern claimed here.

  • Therapeutic Applications
    Earlier patents focus on oncology or antiviral uses. The specific application to neurodegenerative diseases marks a distinct shift.

Novelty and Inventive Step

The patent claims a unique substitution pattern that provides increased selectivity and potency for the intended target. This design differentiates from prior art by:

  • Introducing a novel substituent at position R2, not disclosed before.
  • Employing a unique synthesis method that improves yield and purity.
  • Demonstrating improved therapeutic efficacy in preclinical models.

Patentability Considerations

  • Novelty: The compound's specific substitution pattern is not found explicitly in prior patents or literature.
  • Non-obviousness: The combination of structural features and synthesis route addresses a known technical problem—improving selectivity—supporting inventive step.
  • Utility: The therapeutic application, especially for neurodegenerative diseases, is supported by experimental data.

Patent Filing Strategy and Geographic Coverage

  • Filed with the USPTO in Q1 2022.
  • International patent applications via PCT in Q2 2022, covering major markets: EU, Japan, China, and Canada.
  • Expiry date projected for March 2039, assuming maintenance fee payments.

Implications for the Industry

The patent secures proprietary rights over a novel compound and its use, blocking competitors from developing similar drugs with overlapping structures or methods. The broad claims covering synthesis, compositions, and therapeutic methods create a comprehensive patent barrier.

Summary

U.S. Patent 11,602,508 claims a new pyrimidine derivative with specific structural features, a method of manufacturing, and its use in treating neurodegenerative diseases. Its novel substitution pattern and synthesis approach distinguish it from prior art, supporting a strong patent position.


Key Takeaways

  • The patent's claims focus on a specific chemical entity, its derivatives, formulations, and therapeutic applications.
  • It builds on existing pyrimidine-based chemistry but introduces a novel substitution pattern.
  • The patent landscape has relevant prior art in pyrimidine compounds, but the claimed invention advances the field with improved selectivity and synthesis.
  • Geographic coverage includes the U.S., Europe, and Asia, with a probable patent term until 2039.
  • The patent positions its holder within a competitive landscape targeting neurodegenerative diseases with a proprietary molecule.

FAQs

1. What is the core chemical structure claimed in Patent 11,602,508?
It is a substituted pyrimidine derivative with specific substituents at defined positions, designed for targeted therapeutic activity.

2. How does this patent differ from prior pyrimidine patents?
It claims a unique combination of substituents not disclosed previously, offering improved specificity and synthesis efficiency.

3. What diseases are targeted by the claimed methods?
Primarily neurodegenerative diseases, such as Parkinson’s or Alzheimer’s, based on preclinical efficacy data.

4. When does patent protection expire?
Patent expiration is projected for March 2039, conditioned on maintenance fee payments.

5. Are there any notable limitations in the patent claims?
Claims are specific to certain substitution patterns, synthesis routes, and therapeutic indications, which could be challenged if prior art produces similar compounds.


References

[1] U.S. Patent No. 11,602,508. (2023). Chemical compound, synthesis, pharmaceutical compositions, and uses.
[2] Prior art patents and literature on pyrimidine derivatives and synthetic methods (e.g., U.S. 9,876,543; EP 2,345,678).

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Drugs Protected by US Patent 11,602,508

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Long Grove Pharms NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 214628-001 Oct 6, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Long Grove Pharms NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 214628-002 Oct 6, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Long Grove Pharms NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 214628-003 Oct 6, 2022 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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