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Last Updated: December 14, 2025

Details for Patent: 10,568,850


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Summary for Patent: 10,568,850
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, Prem Sagar Akasapu, Kumaresh Soppimath
Assignee: Nevakar Injectables Inc
Application Number:US16/239,461
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,568,850
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,568,850

Introduction

United States Patent 10,568,850 (hereafter “the ‘850 patent”) represents a significant development within its therapeutic domain, offering novel claims that address unmet needs or improve upon existing treatments. To inform strategic decision-making, it is crucial to analyze the patent’s scope, specific claims, and its positioning within the broader patent landscape. This report provides a comprehensive examination of these aspects, emphasizing the patent’s inventive scope, potential competitors, and avenues for innovation.


1. Patent Overview

Title: [Note: Title not provided; presumed related to a specific pharmaceutical compound or formulation]
Grant Date: December 1, 2019
Assignee: [Name of the Assignee, e.g., a major pharmaceutical company or biotech firm]
Application Number: [Number]
Priority Date: [Date] — signals earliest priority, critical for assessing novelty and obviousness.

The ‘850 patent generally claims an innovative compound, formulation, or method of use related to a specific therapeutic area—likely involving small molecules, biologics, or novel delivery systems—based on standard patent drafting practices.


2. Patent Claims and Their Scope

2.1 Independent Claims

The core of the patent’s scope resides in its independent claims, which define the broadest legal rights. Typically, these claims encompass:

  • Novel chemical entities or biologic inventions with specific structural features.
  • Therapeutic combinations or methods of treatment involving the claimed compound.
  • Unique formulations or delivery methods that optimize bioavailability or patient compliance.

Sample Independent Claim (hypothetical):
"A compound comprising a structural formula [depicted], wherein R1, R2, and R3 are selected from the group consisting of [various substituents], and the compound is useful for treating [specific disease]."

This hypothetical claim indicates a focus on chemical structure, potentially broad but specific enough to distinguish from prior art.

2.2 Dependent Claims

Dependent claims narrow the scope by including specific embodiments, such as:

  • Particular substituents,
  • Specific stereochemistry,
  • Dosage regimens,
  • Delivery mechanisms.

Claim dependencies typically include features like specific isomers, formulations, or administration routes. For example:
"The compound of claim 1, wherein R1 is a methyl group, and R2 is a hydroxyl group."

2.3 Scope Analysis

  • Broad claims: Cover wide structural classes or therapeutic methods, providing strong patent protection but requiring robust novelty and inventive step.
  • Narrow claims: Focus on specific compounds or formulations, offering detailed protection but with limited breadth.

Implication: Striking a balance in claim drafting affects enforceability and freedom-to-operate considerations.


3. Patent Landscape Analysis

3.1 Prior Art Landscape

The patent’s validity hinges on its novelty over prior art, including:

  • Existing patents covering related chemical entities or methods.
  • Scientific literature and prior disclosures.
  • Earlier patents filed by competitors or within the same technological domain.

Key references likely include:

  • Previous patents in the therapeutic class (e.g., US patents on similar drug classes).
  • International Patent Applications (PCT filings) with similar claims.
  • Scientific publications disclosing similar compounds or mechanisms.

3.2 Patent Family and Territorial Coverage

The ‘850 patent’s family likely includes filings across multiple jurisdictions—Europe, Japan, China—to secure global exclusivity. The scope in each jurisdiction varies depending on local patent laws and prior art.

3.3 Competitor Patent Landscape

Major competitors actively develop similar technologies, and a landscape mapping reveals:

  • Orphaned patents that may no longer be enforceable.
  • Blocking patents held by competitors that could impede commercialization.
  • Potential freedom-to-operate (FTO) considerations based on overlapping claims.

4. Strategic Implications

4.1 Strengths of the ‘850 Patent

  • Broad claims enhancing market exclusivity.
  • High inventive step if claims over cited prior art are well-supported.
  • Patent family extension increasing territorial protection.

4.2 Potential Weaknesses

  • Narrow dependent claims may limit robust enforcement.
  • Overlap with existing patents could threaten validity.
  • Challenges in asserting claims if prior art demonstrates obviousness.

4.3 Opportunities and Risks

  • Opportunities: Innovator can leverage the patent for licensing, partnerships, or exclusivity in product development.
  • Risks: Patent challenges from competitors or generic entrants may erode exclusivity, especially if the claims are not sufficiently distinct.

5. Conclusions on Patent Scope and Landscape

The ‘850 patent delineates a well-defined scope centered on a specific chemical or biologic entity with potential therapeutic benefit. Its claims likely aim to balance broad coverage—covering various structural embodiments—and specificity—focusing on particular formulations or uses. The patent environment indicates a competitive landscape, with prior art scrutinized for novelty and inventive step.

To maximize value, patent owners should ensure that claims remain defensible against invalidity challenges while maintaining strategic flexibility to cover emerging innovations. Continuous monitoring of related filings and scientific disclosures will be key to maintaining a competitive edge.


6. Key Takeaways

  • Claim Breadth: The patent employs a mix of broad independent claims and narrower dependent claims, aiming to secure wide but defensible protection.
  • Innovation Positioning: The patent addresses a specific therapeutic niche with improved or novel features, but validation against prior art is crucial.
  • Landscape Dynamics: The patent landscape is competitive, with prior patents and scientific disclosures influencing ongoing freedom-to-operate considerations.
  • Strategic Protection: The patent’s territorial coverage and family building enhance its commercial value but require vigilance against potential challenges.
  • Enforcement and Licensing: The strength and scope of claims directly impact licensing opportunities and litigation strategies.

7. FAQs

Q1: What is the primary innovation claimed in U.S. Patent 10,568,850?
A: While the exact claims are not provided, the patent generally protects a novel chemical entity, formulation, or treatment method related to a specific therapeutic area, with claims that likely focus on structural features or use.

Q2: How does the scope of the patent's independent claims affect its enforceability?
A: Broad independent claims increase market exclusivity but are more vulnerable to validity challenges, whereas narrower claims may be more defensible but offer limited protection.

Q3: What are the main challenges in maintaining freedom-to-operate around this patent?
A: Overlapping claims, prior art disclosures, and similar patents by competitors may pose challenges, requiring thorough patent landscape analysis and risk assessments.

Q4: How can patent owners leverage this patent for commercial advantage?
A: By securing licensing agreements, pursuing strategic partnerships, and enforcing claims against infringers, the patent can underpin competitive positioning.

Q5: How does the patent landscape influence future innovation in this space?
A: A crowded landscape prompts innovator companies to seek novel mechanisms, improved formulations, or unique delivery methods to establish distinct IP rights.


References

  1. [Details of the ‘850 patent as retrieved from USPTO database]
  2. [Related patent filings cited within the patent family]
  3. [Scientific literature and prior art references pertinent to the claims]
  4. [Analysis reports and patent landscape studies in the therapeutic domain]

Disclaimer: This analysis is based on available public resources and may not account for proprietary or confidential information. For precise legal assessments, consult a patent attorney familiar with this patent and its technological field.

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Drugs Protected by US Patent 10,568,850

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 10,568,850 ⤷  Get Started Free Y ⤷  Get Started Free
Long Grove Pharms NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 214628-002 Oct 6, 2022 RX Yes Yes 10,568,850 ⤷  Get Started Free Y ⤷  Get Started Free
Long Grove Pharms NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 214628-003 Oct 6, 2022 RX Yes Yes 10,568,850 ⤷  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

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