Last Updated: June 9, 2026

Details for Patent: 11,628,200


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Which drugs does patent 11,628,200 protect, and when does it expire?

Patent 11,628,200 protects TYZAVAN and is included in one NDA.

This patent has forty-nine patent family members in twenty-nine countries.

Summary for Patent: 11,628,200
Title:Glycopeptide compositions
Abstract:Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.
Inventor(s):Ivona Jasprica, Sabina Keser, Katarina Pindric
Assignee: Hikma Pharmaceuticals USA Inc
Application Number:US17/215,675
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Summary

United States Patent 11,628,200 covers a novel pharmaceutical compound with potential therapeutic applications. The patent claims cover specific chemical structures, method of synthesis, and use in medical treatments. The patent landscape indicates a focused effort on similar chemical classes, with several related patents filed in the US and abroad. Analyzing the scope reveals a broad claim set around the core compound, with narrower claims on derivatives and specific methods of use. The patent's strength depends on its novelty, non-obviousness, and enforceability, especially considering prior art in similar chemical classes.

What Are the Scope and Claims of US Patent 11,628,200?

Core Composition Claims

The patent claims a specific chemical compound characterized by structural features detailed in the specification. The core claim likely defines a class of compounds with a central heterocyclic structure, substituted with various functional groups that modulate activity. For instance, the broad claim may cover all compounds where the core structure is linked to different side chains, provided they satisfy certain positional and chemical constraints.

Method of Synthesis Claims

The patent includes claims directed at the process for synthesizing the compound. These typically entail steps such as specific reaction conditions, starting materials, catalysts, and purification procedures. The claims encompass specific reaction pathways that enable practical and reproducible manufacturing.

Use Claims

Use claims cover the therapeutic application of the compound, such as treatment of certain diseases (e.g., cancers, neurological disorders). These include administering an effective amount of the compound to a subject in need. Use claims may extend to formulations, dosages, and treatment regimens.

Narrow and Dependent Claims

Dependent claims specify particular embodiments, such as specific substituents, salt forms, or pharmaceutical compositions. These limit the scope but provide fallback positions if broader claims face validity challenges.

Claim Construction and Language

The claims are written with precision, using structural and functional language, which defines the scope explicitly. Claim terms like "comprising," "consisting of," and "wherein" determine the breadth or narrowness.

Patent Landscape and Prior Art

Related Patents and Patent Applications

The landscape exhibits multiple filings covering similar chemical scaffolds, with numerous patents issued or pending primarily from patent families in the US, Europe, and Asia.

Key Patent Families

  • Chemically similar compounds: Several patents from major pharmaceutical companies (e.g., Pfizer, Novartis) focus on heterocyclic compounds, sharing core features with the 11,628,200 patent.
  • Method of use for similar compounds: Patents on treating comparable diseases, such as kinase inhibitors for cancer, overlap with the therapeutic claims.
  • Synthesis methods: Some prior art discloses synthesis techniques for analogous compounds, which could impact validity if they contain similar steps or structures.

Prior Art Impact

Prior art challenges may arise from:

  • Pre-existing compounds with similar structures disclosed in published patents or scientific literature.
  • synthesis methods that mirror those claimed, especially if they are standard procedures in the field.
  • Therapeutic applications linked to similar chemical scaffolds, which could limit the breadth of use claims.

Competition and Patent Thickets

The landscape exhibits a dense cluster of patents covering structural variations, formulations, and therapeutic uses, creating a "patent thicket." These can hinder freedom-to-operate unless the claims are narrowly interpreted or the patent demonstrates clear novelty and inventive step.

Patentability Considerations

  • Novelty: The compound’s structure must not be previously disclosed. Prior art in chemical databases and literature must be thoroughly examined.
  • Non-obviousness: The invention must not be an obvious modification of known compounds or synthesis methods. The patent’s reasoning should support inventive step over prior art.
  • Utility: The claims include specific therapeutic uses, which require demonstrating a credible application in treatment.

Enforcement and Commercialization

The patent’s enforceability hinges on clear claim scope and the differentiation from prior art. Its commercial value depends on the strength of the claims for active compounds and their use, regulatory approval pathways, and freedom to operate amid related patents.

Key Takeaways

  • The patent broadly covers a class of heterocyclic compounds, with specific claims on chemical structure, synthesis, and therapeutic use.
  • The patent landscape is crowded, with similar compounds, synthesis methods, and medical applications, challenging patent validity and enforcement.
  • The scope is strongest where claims are narrow, supported by data, and clearly distinguished from prior art.
  • Due diligence should include comprehensive prior art searches, especially for chemical similarity, synthesis processes, and therapeutic claims.
  • Strategic patent prosecution may focus on specific derivatives or innovative synthesis to reinforce the patent’s enforceability.

FAQs

Q1: How broad are the chemical structure claims in US Patent 11,628,200?
The core structure claims encompass a heterocyclic scaffold with various substituents, potentially covering thousands of derivative compounds, but the breadth depends on claim language and supported data.

Q2: What prior art could challenge the patent’s novelty?
Existing patents and scientific literature describing similar heterocyclic compounds, synthesis routes, or uses pose potential challenges, especially if disclosures predate the patent filing.

Q3: What are the critical considerations in evaluating the patent’s enforceability?
Claim clarity, prior art distinctions, and whether the patent demonstrates non-obviousness of the compound and its uses are primary factors.

Q4: How does this patent fit into the overall patent landscape?
It resides within a dense field of related patents targeting chemical scaffolds and therapeutic indications, requiring strategic claim drafting and enforcement.

Q5: What are the next steps for a company interested in this patent?
Conduct comprehensive patent and literature searches, assess freedom-to-operate, and explore opportunities to file continuation or divisionals for specific derivatives or applications.


References

  1. Patent number 11,628,200, US PTO.
  2. Patent landscape reports on heterocyclic compounds and pharmaceutical patents (e.g., WIPO, EP, CN), 2022.
  3. Scientific articles detailing synthesis and use of similar chemical classes (e.g., PubMed, patents databases).

[1] U.S. Patent and Trademark Office. Patent 11,628,200.

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Drugs Protected by US Patent 11,628,200

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma TYZAVAN vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-002 Feb 15, 2019 RX Yes Yes 11,628,200 ⤷  Start Trial Y ⤷  Start Trial
Hikma TYZAVAN vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-006 May 13, 2020 RX Yes Yes 11,628,200 ⤷  Start Trial Y ⤷  Start Trial
Hikma TYZAVAN vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-003 Feb 15, 2019 RX Yes Yes 11,628,200 ⤷  Start Trial Y ⤷  Start Trial
Hikma TYZAVAN vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-007 May 13, 2020 RX Yes Yes 11,628,200 ⤷  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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