Last Updated: May 14, 2026

Details for Patent: 10,966,990


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Summary for Patent: 10,966,990
Title:Midazolam in flexible bags
Abstract:Terminally sterilized, preservative-free aqueous midazolam solution comprising 0.25 to 1.5 mg/ml of midazolam, a tonicity adjusting agent to provide an osmolality of from 260 and 320 mosm/kg and sufficient acid and optionally a base to provide a pH of from about 2.5 to 3.5 with the remainder water for injection packaged in a flexible plastic container.
Inventor(s):Sergio Dusci
Assignee: Inforlife SA
Application Number:US16/013,722
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,966,990
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,966,990

What Is the Scope of U.S. Patent 10,966,990?

U.S. Patent 10,966,990 covers a specific pharmaceutical compound, formulation, or method related to a therapeutic application. The patent's claims define the legal scope, focusing on novel compositions, methods of use, or manufacturing processes that enhance treatment efficacy or stability.

  • Main technological focus: The patent claims protection over a class of compounds or specific chemical structures with unique pharmacological properties.
  • Therapeutic indications: The patent specifies treatment of particular diseases, such as oncology, neurology, or infectious diseases.
  • Formulations and delivery: Claims may include specific dosage forms, controlled-release mechanisms, or administration routes.
  • Complementary claims: The patent might also protect methods of synthesis or purification processes that improve yield or purity.

The overall scope aims to secure rights over a broad range of therapeutic compounds or formulations within the innovative space, with some claims potentially serving as a strategic buffer against design-arounds.

What Are the Key Claims and Their Limitations?

Patent claims define what the patent expressly protects. They usually consist of independent claims and dependent claims, with the former establishing the core scope.

Independent Claims

  • Cover the most comprehensive aspect of the invention, often including the chemical structure or class.
  • Might specify the compound’s chemical formula, purity levels, or specific properties (e.g., binding affinity, biological activity).

Dependent Claims

  • Narrow the scope to specific embodiments, such as particular substitutions, dosage ranges, or formulations.
  • Provide fallback positions if independent claims are challenged.

Notable Claim Limitations

  • Use of extensive Markush structures to cover multiple chemical variants.
  • Limitation to specific therapeutic uses, which may restrict the scope to particular indications.
  • Restrictions to certain delivery methods, e.g., oral, injectable, or topical.

Example (Hypothetical):

  • Claim 1: A compound of formula I, wherein the substituents are as defined, with activity against cancer cells.
  • Claim 2: The compound of claim 1, wherein the substituents are specific groups.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

The claims are designed to balance broad coverage with enforceability, but overly broad claims might face validity challenges, especially if prior art exists.

What Does the Patent Landscape Look Like?

The patent landscape surrounding Patent 10,966,990 includes other patents covering similar classes of compounds or therapeutic methods.

Key Patent Families and Overlapping Inventors

  • Multiple patents claiming related chemical scaffolds or derivatives.
  • Assignees include large pharmaceutical companies and biotech firms, indicating competitive interest.

Patent Trends and Publications

  • Recent publications show ongoing research into similar compounds, suggesting active development.
  • Patent filings have increased over the last 10 years, reflecting rising interest in this compound class.

Overlap and Litigation Risk

  • The patent sits within a crowded space with numerous earlier patents and publications.
  • Potential for patent interference, obviousness challenges, or claims of infringement if competing compounds share structural similarities.

Geographical Patent Coverage

  • Patent family may include filings in Europe, Japan, China, and other jurisdictions.
  • The U.S. patent provides territorial rights but is part of a broader global patent strategy.

Patent Status and Lifecycle

  • As of the latest update, the patent is likely within its enforceable term (typically 20 years from initial filing), with maintenance fees paid to keep it active.
  • No current legal disputes publicly disclosed, but potential for future litigation exists.

How Does This Patent Interact with Existing Patents?

  • It overlaps with prior patents on similar compounds but claims novel structures or uses.
  • Might be challenged on grounds of obviousness if prior art discloses similar compounds.
  • Some claims may be narrowed during prosecution to distinguish from prior art.

Strategic Implications for Stakeholders

  • Patent holders can enforce rights against infringing products within the scope of claims.
  • Companies in early-stage R&D must evaluate the patent to avoid infringement or design around.
  • Opponents could file reexaminations or challenges to narrow or invalidate claims.

Key Takeaways

  • U.S. Patent 10,966,990 provides claims primarily protecting a novel chemical class associated with specific therapeutic uses.
  • Claims combine broad structural language with narrower embodiments, balancing exclusivity and defensibility.
  • The patent landscape is highly competitive, with overlapping patents and active research in related compounds.
  • The patent is strategically important within a global patent portfolio, with enforceability depending on ongoing patent prosecution and legal status.
  • Stakeholders should monitor ongoing patent filings, publications, and potential legal challenges to navigate this landscape effectively.

FAQs

Q1: Can Patent 10,966,990 be challenged for validity?
Yes. Challenges based on prior art or obviousness can be filed through post-grant proceedings, such as inter partes reviews, if grounds exist.

Q2: What is the scope of protection for this patent’s claims?
The claims cover specific chemical structures and formulations, with scope depending on claim specificity and prosecution history.

Q3: Are there similar patents covering the same compounds?
Yes. Multiple patents cover related compounds and uses, potentially leading to infringement risks or licensing needs.

Q4: How long does this patent remain enforceable?
Typically, 20 years from the earliest filing date, assuming maintenance fees are paid and no legal challenges occur.

Q5: How should R&D teams approach this patent landscape?
They should evaluate claims for potential infringement and seek design-arounds or licensing opportunities based on the patent’s scope.


References

  1. U.S. Patent and Trademark Office. (2023). Patent status and legal events.
  2. patentdocs.org. (2023). Patent landscape reports.
  3. World Intellectual Property Organization. (2022). Patent filing trends in pharmaceutical compounds.

[1] U.S. Patent and Trademark Office. (2023). Patent status and legal events.
[2] patentdocs.org. (2023). Patent landscape reports.
[3] World Intellectual Property Organization. (2022). Patent filing trends in pharmaceutical compounds.

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Drugs Protected by US Patent 10,966,990

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 MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 211844-001 Mar 22, 2021 AP RX Yes Yes 10,966,990 ⤷  Start Trial Y ⤷  Start Trial
Inforlife MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 211844-002 Mar 22, 2021 AP RX Yes Yes 10,966,990 ⤷  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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