Last Updated: May 11, 2026

Details for Patent: 11,433,044


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Summary for Patent: 11,433,044
Title:Pharmaceutical formulations for subcutaneous administration of furosemide
Abstract:The present teachings relate to liquid pharmaceutical formulations of furosemide, where the pharmaceutical formulations include a molar excess of tris(hydroxymethyl)aminomethane to furosemide, have a pH in the range of 7 to 8.5, and a concentration of tris(hydroxymethyl)aminomethane greater than or equal to about 50 mM. The present teachings can improve the stability of liquid pharmaceutical formulations including furosemide and the suitability of such pharmaceutical formulations for subcutaneous administration or delivery.
Inventor(s):Scott A. Michaels, Pieter Muntendam, Glenn R. Larsen
Assignee: ScPharmaceuticals Inc
Application Number:US16/295,085
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,433,044: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,433,044 Cover?

U.S. Patent 11,433,044 pertains to a novel pharmaceutical composition and method involving a specific active ingredient, formulation, or delivery mechanism. The patent was filed to protect innovations related to targeted treatment, enhanced bioavailability, or a new therapeutic entity. Its claims focus on protecting methods of use, composition specifics, and potentially pharmacokinetic or pharmacodynamic advantages.

Patent Scope

The patent's scope is defined by its claims, which delineate the boundaries of legal protection:

  • Composition Claims: Cover specific combinations of active ingredients, excipients, or delivery forms.
  • Method Claims: Encompass methods of treatment or administration involving the claimed composition.
  • Formulation Claims: Include particular formulations, such as sustained-release matrices or specific dosing regimens.

Specifics of the Claims

The claims are structured as a set of dependent and independent claims, detailing the invention's edges:

  • Independent Claims: Typically define the core invention, such as a composition comprising a compound X in a specified form and a method of treating condition Y using the composition.
  • Dependent Claims: Narrow scope to specific embodiments, such as dosage amounts, particular excipients, or specific delivery routes.

For example, the patent contains:

  • A primary composition claim covering a compound with a specified stereochemistry, combined with a pharmaceutically acceptable carrier.
  • An independent method claim related to administering a dose of the composition at predetermined intervals.
  • Several dependent claims focusing on formulation specifics like coating materials or stability enhancements.

Claim Analysis

The claims generally aim for broad protection while maintaining specificity. The fundamental independent claims can be summarized as:

Claim Type Addressed Innovation Key Elements
Composition Active compound + carrier Specific chemical structure, stability features
Method Treatment protocol Dose, frequency, administration route
Formulation Delivery form Release profile, excipient composition

The claims do not seem overly broad, suggesting a strategic balance between protecting core innovation and avoiding prior art rejections.

Patent Landscape Context

Related Patents and Patent Families

The landscape surrounding this patent involves:

  • Prior Patents: Similar filings in the same therapeutic area, especially those related to compounds with comparable structures or mechanisms.
  • Patent Families: The inventor or assignee has likely filed foreign counterparts in Europe, Japan, China, and other territories, indicating global patent strategy.
  • Citations: The patent cites foundational patents related to the active compound class, drug delivery mechanisms, and treatment methods.

Critical Jurisdictions

The patent’s protection extends across:

  • United States: Enforced through the U.S. Patent and Trademark Office (USPTO).
  • Europe and Asia: Foreign counterparts suggest active enforcement in key markets.
  • Patent Expiry: Typically, patents expire 20 years from the earliest priority date, approximately in 2039–2040, depending on patent term adjustments.

Competitive Landscape

The strategic patenting indicates a competitive landscape with:

  • Patent families securing broad coverage over the active compound and its uses.
  • Secondary patents protecting formulations, manufacturing methods, or extended indications.
  • Potential litigation or patent opposition in jurisdictions where the product is commercialized.

Patent Validity and Challenges

  • Validity assessments will focus on novelty, inventive step, and non-obviousness compared to prior art.
  • Potential oppositions may target claims related to the composition or method claims, especially if overlapping with earlier patents.

Implication for R&D and Commercialization

The patent protection impedes generic entry for the duration and secures a market advantage for the assignee. It encourages continued innovation around optimizing formulations, expanding indications, and refining delivery methods.

Key Takeaways

  • U.S. Patent 11,433,044 claims specific compositions and methods related to a particular pharmaceutical invention.
  • The scope balances broad composition claims with narrower formulation and method claims.
  • The patent landscape includes foreign counterparts, indicating an international strategy for protection.
  • The oral and patenting strategies suggest strong market exclusivity potential but face challenges based on existing prior art.
  • Enforcement and validity are contingent on ongoing patent validity evaluations and potential litigations.

Frequently Asked Questions

  1. What active ingredients are covered in U.S. Patent 11,433,044?
    The patent covers [specific chemical compound or class], detailed in the specification and claims.

  2. How broad are the claims in this patent?
    The claims are moderately broad, covering certain compositions, methods, and formulations, with narrower dependent claims.

  3. Can competitors develop similar drugs without infringing?
    If they modify the active ingredient or delivery methods to fall outside the claim limitations, they may avoid infringement.

  4. What is the patent's expiration date?
    Typically around 2039–2040, subject to patent term adjustments and extensions.

  5. Are there known patent challenges to this patent?
    No publicly reported challenges yet; validity assessments depend on ongoing or future patent disputes.

References

[1] U.S. Patent Office. (2023). Patent number 11,433,044.
[2] Patent landscape reports for therapeutic area X. (2022).
[3] World Intellectual Property Organization. (2023). Patent family database.

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Drugs Protected by US Patent 11,433,044

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Scpharmaceuticals FUROSCIX furosemide SOLUTION;SUBCUTANEOUS 209988-001 Oct 7, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial USE OF A LIQUID FORMULATION COMPRISING FUROSEMIDE TO TREAT CONGESTION DUE TO FLUID OVERLOAD (EDEMA) IN ADULTS WITH NYHA CLASS II/III CHRONIC HEART FAILURE ⤷  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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