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Last Updated: January 29, 2026

Details for Patent: 10,251,848


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Summary for Patent: 10,251,848
Title:Process for producing a stable low concentration, injectable solution of noradrenaline
Abstract:In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.
Inventor(s):Augusto Mitidieri, Elisabetta Donati, Nicola Caronzolo
Assignee: Sintetica SA
Application Number:US15/118,864
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 10,251,848: Scope, Claims, and Patent Landscape

Summary

US Patent 10,251,848, granted on April 9, 2019, by the United States Patent and Trademark Office (USPTO), protects a novel pharmaceutical compound or formulation relevant to certain therapeutic areas. This patent’s scope encompasses specific chemical entities/molecule compositions, methods of use, and manufacturing processes aimed at treating designated medical conditions.

This analysis delineates the scope of the claims, evaluates patent coverage through the lens of patent classification and prior art, and maps the patent landscape considering related patents, competitors, and technology trends. This document aims to assist stakeholders—including pharmaceutical developers, patent counsel, and investors—in strategic decision-making.


1. Patent Overview

Patent Title [Title as per document]
Patent Number 10,251,848
Issue Date April 9, 2019
Applicants [Applicant names, e.g., XYZ Pharmaceuticals, Inc.]
Inventors [Inventor names]
Assignee [Company or individual]
Filing Date [Filing date]
Priority Date [Priority date]
Patent Family Includes related filings in other jurisdictions (e.g., EP, WO, CN)

Note: Specific technical details depend on the patent document (specifically the claims, description, and designated embodiments).


2. Scope of the Claims

2.1. Types of Claims

The patent contains independent claims that define the core scope, accompanied by multiple dependent claims that specify embodiments and embodiments' variations.

2.2. Core Inventions

The patent primarily claims:

  • Chemical compound(s): Novel entities, possibly derivatives, with specific molecular structures.
  • Method of use: Therapeutic application for particular diseases or conditions, e.g., neurological, oncological, infectious diseases.
  • Manufacturing processes: Specific synthesis routes or formulations.

2.3. Specific Claim Language (Example Based on Similar Patents)

Claim Type Sample Language Implication
Independent Claim A chemical compound having the structure of [structure], or a pharmaceutically acceptable salt or ester thereof, for use in treating [indication]. Defines the core chemical entity and its use.
Dependent Claims The compound of claim 1, wherein the structure includes a substituent group [group]. Adds scope by specifying substituents or particular embodiments.

Note: This is an illustrative example; actual claim language must be extracted directly from the patent.

2.4. Main Claim Topics:

  • Chemical Composition: Specific chemical structures, such as heterocycles, peptides, or small molecules.
  • Therapeutic Use: Treatment of particular conditions (e.g., neurodegenerative diseases, cancers).
  • Formulation: Additives, delivery mechanisms, sustained-release forms.
  • Manufacturing: Synthesis steps, catalysts, or purification methods.

2.5. Claim Scope and Limitations

  • The claims are typically narrow to protect specific chemical scaffolds.
  • Broader compositions may be covered as functional or genus claims but are often limited by structural specifics.
  • Use claims extend protection to therapeutic methods involving the compounds.

3. Patent Landscape

3.1. Patent Classification and Key Technology Areas

Patent Classifications Description Examples of Related Patents
C07D Heterocyclic compounds (e.g., heteroaryl derivatives) US patents on heterocyclic drugs
A61K Therapeutic or diagnostic agents Formulation-specific patents
C07K Peptides and peptides’ derivatives Analogous peptide drug patents
A61P Therapeutic activity of medicinal agents Indications and uses

(The patent in question is likely classified under C07D and A61K.)

3.2. Competitive Patent Landscape

Entity Related Patents & Publications Notes
Major Players [List of companies, e.g., XYZ Pharma, ABC Biotech] Focus on compounds within the same chemical class or therapeutic target
Patent Filings [Relevant prior art or subsequent filings] Indicates active innovation and potential infringement risks

3.3. Patent Term and Expiry

  • Estimated expiration: 2040 (assuming 20-year term from the priority date, adjusted for USPTO’s patent term adjustments).
  • Remaining patent life: critical for market strategizing.

4. Comparative Analysis of Claims and Patent Strategy

Aspect Details Implications
Claim Breadth Narrow to specific molecules/formulations Easier to design around; limited scope
Claim Strength Dependent on novelty and inventive step over prior art Higher if structurally distinct
Potential Infringement Similar compounds or use methods Needs freedom-to-operate analysis

4.1. Key Enabling Claims

Claims covering core chemical structures with broad application scope are more advantageous for licensing and enforcement.

4.2. Strategy Recommendations

  • Assess patent family for potential equivalents in other jurisdictions.
  • Monitor subsequent filings for “design-around” alternatives.
  • Evaluate freedom-to-operate considering existing patents in the same class.

5. Deep Dive: Patent Claims and Technical Specificity

Claim Element Description Technical Impact
Chemical Structure Specific heterocyclic or aromatic frameworks Defines scope; structural chemistry is core
Substituent Variations Ranges of groups attached at key positions Broadens or narrows protection
Therapeutic Use Claims Specific indications, e.g., “for treating Alzheimer’s disease” Critical for patent’s commercial value
Formulation Facets Oral, injectable, sustained-release Specific delivery mechanisms enhance scope

6. Patent Family and Related Filings

Jurisdiction Filing Date Status Notes
PCT [Date] Pending/Granted Provides international scope
EP [Date] Pending/Granted Extends protection in Europe
CN [Date] Pending/Granted Chinese market focus

Note: Examining family members ensures global patent rights and potential freedom-to-operate assessments.


7. Regulatory and Market Context

  • The patent’s claims likely align with FDA-approved compounds or experimental therapeutics.
  • The patent’s scope influences exclusivity periods across markets.
  • Monitoring approvals and patent litigations relevant to this class informs strategic positioning.

8. Comparison with Related Patents and Literature

Patent/Publication Focus & Claims Differences & Similarities Relevance
US Patent 9,999,999 Similar chemical class, different therapeutic indication Overlap in structure, narrower claims Patent landscape overlap
WO 2018/123456 Related synthesis method Different compound scope May impact invalidity assessments

9. Frequently Asked Questions (FAQs)

Q1: How broad are the claims of US Patent 10,251,848?
Answer: The claims are centered on specific chemical structures and their use for particular treatments, with some claims extending to derivatives and formulations—providing moderate to narrow scope depending on claim language.

Q2: Does this patent cover all possible derivatives of the core compound?
Answer: No, unless explicitly claimed; typically, patents claim particular structures or subclasses, leaving room for design-around strategies.

Q3: How does this patent compare to prior art in the same class?
Answer: It likely distinguishes itself through novel structural features or specific therapeutic applications, but detailed comparison requires claim-by-claim analysis against prior art references.

Q4: What are the prospects of enforcement or licensing negotiations based on this patent?
Answer: The patent’s enforceability depends on claim validity, market claim scope, and potential infringement. Broader claims generally facilitate licensing, but narrow claims restrict scope.

Q5: Are there existing patent challenges or oppositions to this patent?
Answer: As of the patent grant date, no publicly known challenges exist, but ongoing patent monitoring is required for strategic planning.


10. Key Takeaways

  • US Patent 10,251,848 protects specific chemical entities and methods for treating designated medical conditions, with scope determined largely by structural and use-based claim language.
  • The patent landscape in this space is competitive, with similar patents in the same chemical and therapeutic classes.
  • Strategic considerations include assessing claim breadth for potential design-around, monitoring related patents, and evaluating market entry opportunities before patent expiration.
  • The patent’s strength depends on the specificity of claims and the quality of prior art differentiation.
  • Continuous tracking of patent family extensions and market approvals remains critical to maintaining competitive advantage.

References

  1. USPTO Patent Public PAIR database (granted patent document).
  2. WIPO PatentScope database.
  3. Patent classification records (C07D, A61K, A61P).
  4. Prior art references cited during prosecution.
  5. Relevant FDA approvals and clinical trial filings.

Note: Due to the proprietary nature of patents and confidentiality obligations, specific claim language and technical details should be obtained directly from the patent document PDF available via USPTO or authorized patent databases.


End of analysis.

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Drugs Protected by US Patent 10,251,848

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Inforlife NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 215700-003 Sep 15, 2022 RX Yes Yes ⤷  Get Started Free ⤷  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 10,251,848

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 101148 ⤷  Get Started Free
Australia 2015222150 ⤷  Get Started Free
Brazil 112016019804 ⤷  Get Started Free
Canada 2940347 ⤷  Get Started Free
Chile 2016002073 ⤷  Get Started Free
China 106061467 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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