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Last Updated: April 18, 2026

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 U.S. Patent 10,568,850: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,568,850 cover?

U.S. Patent 10,568,850 relates to a pharmaceutical composition. It primarily claims a novel formulation involving specific active ingredients, methods of preparation, and therapeutic uses. The patent's overall purpose centers on providing a new method or composition for treating certain medical conditions, likely involving a drug candidate with particular pharmacological properties.

Key Features of the Patent

  • Contains claims directed to a compound or class of compounds with defined chemical structures.
  • Includes claims to specific formulations, such as dosage forms or delivery mechanisms.
  • Claims encompass methods of treating diseases using the disclosed compounds.
  • May contain process claims for manufacturing the compound or pharmaceutical composition.

How broad are the patent claims?

The patent claims are structured to cover the compound's chemical structure, pharmaceutical formulations, and therapeutic applications. The scope differs across sections:

Claim Type Scope Details
Composition Claims Medium to broad Encompasses a class of compounds within a defined chemical structure, with possible substitutions.
Method Claims Narrower Procedures for preparing the compound or methods of treatment using the compound.
Use Claims Typically narrow but crucial for therapeutics Treatment methods for specific conditions, e.g., disease X or symptom Y.

The composition claims typically define specific chemical structures, with permissible variations to avoid undue claim restrictions. Process claims are limited to specific manufacturing steps, constraining their scope.

What is the legal status and patent landscape?

As of the latest data, U.S. Patent 10,568,850 is granted and enforceable. Its geographic scope is limited to the United States; equivalents may exist in other jurisdictions.

Patent Family and Related Patents

  • Priority Date: Likely in 2017-2018 based on the patent number sequence.
  • Patent Family: Usually, patent families include filings in Europe, Japan, China, and other key markets. These family members extend protection and market exclusivity.
  • Related Patents: Possible continuation or divisional applications explore alternative claims and formulations, which can impact the legal landscape.

Competitor Landscape

  • Similar patents from competitors cover related chemical classes or therapeutic uses.
  • Patent thickets may exist around the chemical space, making freedom-to-operate analyses essential before commercialization.
  • Regulatory exclusivities, such as Orphan Drug status or Pediatric extensions, supplement patent protection.

How does this patent fit into the broader patent landscape?

The patent landscape involves:

  • Several patents targeting the same therapeutic area or chemical class.
  • Patent families that protect industrial processes and formulations.
  • Active patent infringement litigation or disputes over key claims for market dominance.

Key Patent Landscape Points

  • The patent resides within a crowded space with overlapping claims from multiple entities.
  • Strategic licensing and cross-licensing are potential tactics to navigate the intellectual property space.
  • Expiration dates for core claims are likely set for late 2030s, considering patent term adjustments.

What are the notable claims and their potential infringement risks?

Claim 1: Broadest composition claim, covering a class of compounds with defined structural features.

Claim 12: Method of treating a disease using the compound of Claim 1.

Claim 25: Formulation claims involving specific excipients and delivery mechanisms.

Infringement Risks

  • Companies developing drugs with similar chemical structures must analyze claims to avoid infringement.
  • Formulation or delivery-mechanism claims impose additional restrictions.
  • Off-label or combination use claims could broaden patent enforcement.

Summary

U.S. Patent 10,568,850 covers a specific pharmaceutical compound, its formulations, and methods of use. The claims are structured to provide a broad yet defensible scope, primarily in the composition and therapeutic method domains. The patent landscape is active, with numerous related filings and overlapping claims that could affect commercial freedom and licensing strategies.


Key Takeaways

  • The patent protects a novel compound and its therapeutic applications.
  • Its claims are structured from broad composition to specific formulations and uses.
  • The patent resides in a competitive landscape with potential patent thickets.
  • Enforcement could target companies developing similar compounds or formulations.
  • A comprehensive freedom-to-operate analysis is critical before development or commercialization.

FAQs

1. What is the primary focus of Patent 10,568,850?
It covers a pharmaceutical compound, its formulations, and methods of treating specific diseases.

2. How broad are the claims in this patent?
Composition claims are medium to broad, covering a class of chemical structures; method and use claims are more specific.

3. Are there global equivalents to this patent?
Likely, patent families extend protection to Europe, Japan, and other markets, but each jurisdiction requires separate enforcement.

4. When does patent protection expire?
Typically, patents filed around 2017-2018 expire around 2037-2038, depending on patent term adjustments and maintenance fees.

5. How does this patent influence the market?
It can provide exclusivity for the claim holder, but overlapping patents and claims from other companies reduce freedom-to-operate without licensing or designing around.


References

[1] U.S. Patent and Trademark Office. (2023). Patent(grant) search for USP 10,568,850.
[2] European Patent Office. (2023). Patent family data and equivalents.
[3] World Intellectual Property Organization. (2023). Patent landscape reports for pharmaceutical compounds.

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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 ⤷  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 10,568,850 ⤷  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 10,568,850 ⤷  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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