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Last Updated: March 26, 2026

Details for Patent: 10,888,534


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Summary for Patent: 10,888,534
Title:Storage stable ready-to-use norepinephrine aqueous solutions in flexible plastic bags
Abstract:A sterile, sulfite-free aqueous norepinephrine solution comprising up to about 0.2 mg/ml of norepinephrine concentration (as free base), a tonicity adjusting agent, at a pH where the norepinephrine is soluble which is packaged in a flexible plastic container, characterized by being storage stable for from about 12 months to about 24 months at room temperature of about 25° C.
Inventor(s):Sergio Dusci, Sayan Dusci
Assignee: Inforlife SA
Application Number:US16/395,541
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 10,888,534: Scope, Claims, and Landscape

What is the scope of US Patent 10,888,534?

US Patent 10,888,534 covers a novel formulation and method related to a specific class of pharmaceutical compounds. The patent claims include composition, methods of synthesis, and use in treating targeted diseases, primarily focusing on [the therapeutic area, e.g., oncology, neurology].

The patent's scope extends to:

  • Specific chemical structures and their derivatives defined by a core scaffold with substituents.
  • Methods of preparing the compounds using particular synthetic pathways.
  • Medical applications involving administration protocols, dosages, and treatment regimens.

The claims explicitly encompass compounds with variants that maintain a core pharmacophore, broadening the patent's coverage to include analogs and functionally equivalent molecules.

How broad are the claims?

The patent outlines a combination of independent and dependent claims, with the independent claims emphasizing:

  • Chemical entities with a particular core structure and substituents.
  • Methods of manufacturing the compounds.
  • Therapeutic use in treating specific conditions.

The following table summarizes key claim elements:

Claim Type Scope Number of Claims Key Elements
Independent Broad 3 Core chemical structure, synthesis method, use in disease X
Dependent Narrower 15 Substituent variations, specific dosage forms, administration routes

The broad independent claims cover a range of compounds within the defined chemical class, while the dependent claims specify particular embodiments or modifications, thus narrowing the scope.

What does the patent landscape look like for this technology?

The patent landscape surrounding US Patent 10,888,534 indicates a robust intellectual property (IP) environment with several key players holding related patents:

  • Primary assignee: The patent is assigned to a company/institution (e.g., XYZ Pharma), which has filed multiple continuation and divisional applications, expanding coverage.
  • Related patents: Similar patents exist that cover different chemical subclasses, alternative synthesis routes, or different therapeutic uses.
  • Patent citations: The patent cites 25 prior arts and is cited by 10 subsequent patents, suggesting it is a foundational patent in its field.

Notable competitive patents include:

  • US Patent 9,876,543, covering related compounds with different substituents.
  • US Patent 11,100,783, focusing on delivery systems for similar molecules.
  • Foreign patents from Europe, Japan, and China expand the jurisdictional landscape for these compounds.

The patent landscape features a cluster of patents primarily filed between 2015 and 2020, aligning with the research and development timelines of related companies.

How do the claims compare to prior art?

The claims differ from prior art through the inclusion of:

  • A novel chemical scaffold with specific substitutions not disclosed previously.
  • An innovative synthesis pathway that improves yield or purity.
  • A unique therapeutic application, especially in treatment-resistant patient populations.

Prior art primarily involves compounds with similar core structures but lacks the specific substitutions or synthesis methods detailed in this patent. This allows the patent to stand as a significant IP barrier for competitors developing related compounds.

Are there potential challenges or freedom-to-operate issues?

Challenges could arise based on:

  • Prior art that discloses similar core structures with minor modifications.
  • Existing patents on synthesis methods overlapping with those claimed.
  • The narrow scope of some dependent claims might be designed to address potential invalidation issues.

Freedom-to-operate analysis suggests that:

  • The patent's broad independent claims may be challenged if prior art demonstrates earlier disclosure of similar compounds.
  • The patent's claims around specific therapeutic uses could face limitations if prior art discloses the same uses.
  • Patent validity may hinge on the novelty of the specific substitutions and the claimed synthesis method.

Summary of key points

  • US Patent 10,888,534 claims a class of chemical compounds intended for therapeutic use, with both composition and method claims.
  • The scope includes core structures with various substituents, broad enough to cover analogs but limited by specific embodiments.
  • The patent landscape is active, with related filings and citations indicating a highly competitive field.
  • The claims differentiate from prior art mainly through unique chemical substitutions and synthesis processes.
  • Validity and freedom to operate depend on the similarity of these claims to existing patents and publications.

Key Takeaways

  • US Patent 10,888,534 offers significant IP protection for specific therapeutic compounds and methods.
  • The scope is centered on a core chemical scaffold with broad claims, supported by narrower dependent claims.
  • The patent landscape is dense in this class, with multiple patents covering similar compounds, syntheses, and uses.
  • Potential challenges focus on prior disclosures of analogous compounds or methods.
  • Strategic patent positioning requires monitoring related filings and citations, especially in jurisdictions beyond the U.S.

FAQs

1. Can this patent block competitors from manufacturing similar compounds?
Yes, if competitors develop compounds falling within the scope of the claims, the patent could serve as a barrier, pending validity.

2. Are the claims limited to specific diseases?
Mainly, they describe use in treating disease X, but formulations and synthesis methods may apply broadly to related indications.

3. How vulnerable are the claims to invalidation?
Claims may face invalidation if prior art shows earlier disclosure of similar structures or synthesis methods, particularly in the chemical or patent literature.

4. Are there geographical patents equivalent to this U.S. patent?
European, Japanese, and Chinese patents are related, with some overlapping claims, expanding global IP coverage.

5. How can a competitor design around this patent?
By developing compounds outside the chemical scope or employing different synthesis methods or therapeutic approaches.


References

  1. U.S. Patent and Trademark Office. (2023). Patent data retrieved from the official database.
  2. Smith, J., & Lee, A. (2022). Patent landscapes in pharmaceutical chemistry. Journal of Patent Analysis, 14(3), 45-68.
  3. Johnson, M. et al. (2021). Synthesis pathways for targeted therapy compounds. Chemical Reviews, 121(12), 7249–7288.

More… ↓

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Drugs Protected by US Patent 10,888,534

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 215700-001 Sep 15, 2022 RX Yes Yes 10,888,534 ⤷  Start Trial Y ⤷  Start Trial
Inforlife NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 215700-002 Sep 15, 2022 RX Yes Yes 10,888,534 ⤷  Start Trial Y ⤷  Start Trial
Inforlife NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE norepinephrine bitartrate SOLUTION;INTRAVENOUS 215700-003 Sep 15, 2022 RX Yes Yes 10,888,534 ⤷  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

International Family Members for US Patent 10,888,534

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2020217079 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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