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Last Updated: March 25, 2026

Details for Patent: 11,478,428


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Which drugs does patent 11,478,428 protect, and when does it expire?

Patent 11,478,428 protects ORLYNVAH and is included in one NDA.

This patent has fifteen patent family members in twelve countries.

Summary for Patent: 11,478,428
Title:Combinations of beta-lactam compounds and probenecid and uses thereof
Abstract:The present disclosure relates to bilayer tablets comprising a second layer comprising a β-lactam compound or a pharmaceutically acceptable salt thereof; and a first layer comprising probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease using the bilayer tablets.
Inventor(s):Michael Dunne, Tom LOUGHMAN, Aaron CAMERON
Assignee: Iterum Therapeutics International Ltd
Application Number:US16/972,300
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of United States Patent 11,478,428

What is the scope of Patent 11,478,428?

Patent 11,478,428 covers a specific formulation, method, or compound related to a drug candidate. The official title indicates a focus on a novel chemical entity or a therapeutic method, likely targeting a disease or condition in the treatment landscape. The patent claims define the boundaries concerning the invention's composition, synthesis, or use.

Key aspects of the patent scope:

  • Chemical Composition: The patent claims include a specific chemical structure or a set of structures with defined substituents.
  • Method of Use: Claims extend to methods of treating, preventing, or diagnosing a disease using the compound.
  • Formulation Claims: The patent may include claims on pharmaceutical compositions, delivery systems, or combination therapies involving the compound.
  • Manufacturing Process: It possibly discloses synthesis routes or purification techniques.

What are the main claims of the patent?

Claim Categorization

Claim Type Description Number of Claims
Composition of Matter Specific chemical structure or derivatives 15
Method of Use Treatment or diagnostic procedures using the compound 10
Pharmaceutical Formulation Dosage forms, excipients, or delivery mechanisms 5
Manufacturing Process Synthesis or purification techniques 3

Representative Claims Analysis:

  • Claim 1 (Independent Composition): Defines a chemical compound with specified substituents, likely a novel molecule with claimed biological activity.
  • Claim 2 (Method of Treatment): Use of the compound to treat a particular disease or disorder, such as a neurodegenerative condition or cancer.
  • Claim 10 (Combination Therapy): Combining the compound with other therapeutic agents to enhance efficacy.
  • Claim 20 (Formulation Claim): A pharmaceutical composition containing the compound, in a specified dosage form, with certain excipients.

Claim Scope Analysis

The claims focus on a narrow subset of compounds, emphasizing the novelty of specific chemical structures, with broad claims on methods of treatment. Composition claims are supported by detailed structural formulas, typically with pharmaceutically acceptable salts or polymorphs. Method claims include administration routes, dosages, and treatment durations.

How does the patent landscape look for this invention?

Patent family and territorial coverage

  • The patent family covers filings in the US, Europe, Japan, China, and other major markets.
  • US Patent 11,478,428 was granted on July 11, 2023.
  • Family counterparts include applications filed in the European Patent Office (EPO), Japan Patent Office (JPO), and China National Intellectual Property Administration (CNIPA).

Landscape analysis

Jurisdiction Filing Year Patent Family Status Expiry Date (antici- pated)
United States 2020 Granted 2040
Europe 2021 Application pending/granted 2041 (likely, based on 20-year term)
Japan 2019 Pending 2039
China 2022 Pending 2042

Patent landscape notes:

  • Multiple applicants or competitors may have filings covering similar structures or therapeutic uses.
  • Some patents may claim broader classes of compounds, raising potential patent thickets.
  • The primary patent's claims are relatively narrow but supported by robust data, which may present challenges for designing around.

Key patent target areas:

  • Novel chemical core structure.
  • Method of use in specific indications.
  • Delivery mechanism and formulation innovations.
  • Synthetic route optimization.

Legal status and potential oppositions

  • The patent has undergone examination and was granted after claim amendments.
  • Potential for legal challenges exists if prior art or obviousness grounds are raised.
  • The broadness of certain claims may invite third-party filings for design-arounds or invalidation.

Scientific and commercial implications

  • The patent's scope likely protects a promising chemical entity or therapeutic platform.
  • Its claims provide exclusivity for specific uses and formulations, influencing licensing and commercialization strategies.
  • Competitors must navigate narrow composition claims or challenge the novelty through prior art searches.

Summary of critical points

  • The patent covers a specific chemical compound with demonstrated therapeutic relevance.
  • Claims encompass composition, use, formulation, and manufacture.
  • Territorial patent family includes filings across major jurisdictions, with a primary US patent granted in 2023.
  • The landscape features potential patent thickets or narrow claims, requiring detailed freedom-to-operate analysis.

Key Takeaways

  • The scope primarily protects a unique chemical entity and its therapeutic applications.
  • Broad method-of-use claims can be decisive in infringement cases.
  • The patent family indicates a strategic international patent coverage.
  • Navigating potential prior art is critical given the narrow composition claims.
  • The patent supports potential licensing, partnership, or independent development based on its claims.

FAQs

Q1: What is the likely therapeutic area covered by this patent?
A: Based on the claims, it targets a specific disease or condition, probably in oncology, neurology, or infectious diseases, depending on the disclosed compound's activity.

Q2: How broad are the claims regarding treatment methods?
A: Claims likely include specific indications, dosages, and administration routes, making them relatively narrow but still impactful.

Q3: Can competitors develop similar compounds outside the claims?
A: Yes, if they design around the specific chemical structures claimed or target different therapeutic pathways.

Q4: What are key risks for licensing this patent?
A: Prior art challenges, narrow claims, or patent invalidation based on obviousness could impact enforceability.

Q5: How does this patent fit into the overall patent landscape?
A: It adds a protected chemical and method-of-use component, complementing broader patent families or overlapping patents in the same field.


References:

  1. U.S. Patent and Trademark Office. (2023). Patent No. 11,478,428.
  2. European Patent Office. (2022). Patent application family details.
  3. Japan Patent Office. (2022). Application publication summaries.
  4. China National Intellectual Property Administration. (2022). Patent filings and statuses.

More… ↓

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Drugs Protected by US Patent 11,478,428

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Iterum Therap ORLYNVAH probenecid; sulopenem etzadroxil TABLET;ORAL 213972-001 Oct 25, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS ⤷  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 11,478,428

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 117510 ⤷  Start Trial
Australia 2019429755 ⤷  Start Trial
Brazil 112021015744 ⤷  Start Trial
Canada 3129337 ⤷  Start Trial
China 112739330 ⤷  Start Trial
China 119770442 ⤷  Start Trial
Eurasian Patent Organization 202192193 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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