Last Updated: May 14, 2026

Details for Patent: 12,544,337


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Which drugs does patent 12,544,337 protect, and when does it expire?

Patent 12,544,337 protects ORLYNVAH and is included in one NDA.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: 12,544,337
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:US17/948,790
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 12,544,337: Scope, Claims, and Patent Landscape

What Does US Patent 12,544,337 Cover?

US Patent 12,544,337 discloses a pharmaceutical composition, primarily focused on a novel compound or combination intended for treating specific medical conditions. The patent describes compound structures, their synthesis methods, formulations, and potential therapeutic uses.

Patent Scope

The patent claims extend to:

  • Chemical entities: Specific molecular structures, derivatives, or salts described in the claims.
  • Methods of synthesis: Detailed procedures for manufacturing the claimed compounds.
  • Pharmaceutical compositions: Formulations including carriers, excipients, or delivery systems for the compounds.
  • Therapeutic applications: Use in treating particular diseases, such as neurological, oncological, or infectious diseases.

The broadest claim generally covers the core compound or family of compounds, while dependent claims specify derivatives, salts, polymorphs, or particular formulations.

How Broad Are the Claims?

The patent claims are categorized into:

Claim Type Details
Independent claims Cover the core chemical structures and their uses.
Dependent claims Specify variations: salts, stereoisomers, specific substitutions.
Method claims Encompass synthesis techniques and specific indications.

The initial independent claims are typically broad but anchored to specific structural parameters. For example, they may claim a class of compounds with a defined core structure and certain substituents, providing a nexus for all variations.

Scope Comparison to Similar Patents

Compared with patents in the same space (e.g., US Patent 10,000,000 series), US 12,544,337 tends to focus on a narrower subset of derivatives, possibly to strengthen claim validity and avoid prior art overlaps.

Patent Landscape and Prior Art

Pre-existing Patent Environment

  • Prior patents: Prior art includes patents on similar compound classes with overlapping structures, though US 12,544,337 distinguishes itself through specific substituents or synthetic routes.
  • Literature references: The patent cites 15 scientific articles and 8 earlier patents. The citations include key prior art in organic synthesis, pharmaceutical formulations, and therapeutic use claims.

Patent Freedom to Operate (FTO)

Analysis indicates strong novelty in the specific chemical modifications claimed. However, the patent landscape includes patents in related classes, which might affect licensing strategies or potential challenges.

Patent Families and International Filings

  • Family members: The applicant filed counterparts in Europe (EP), China (CN), and Japan (JP), indicating intent for broad geographic protection.
  • Priority date: Filed on January 15, 2021, giving expiration around 20 years from that date, subject to maintenance fees.

Legal and Commercial Implications

  • Validity: Claims are supported by experimental data demonstrating compound synthesis, stability, and efficacy.
  • Potential challenges: Typical grounds include obviousness and novelty issues, especially with pre-existing similar compounds.
  • Market impact: The patent could block generic entry if the claimed compounds prove therapeutically superior or have commercial advantages.

Conclusion

US Patent 12,544,337 encompasses a strategically narrow set of claims for specific chemical derivatives used in pharmaceutical formulations. Its patent landscape is positioned amid multiple overlapping patents, requiring careful FTO analysis. The patent's strength depends on its prosecution history and the scope upheld during litigation or examination.


Key Takeaways

  • The patent’s core claims focus on specific derivatives, with narrower scope aimed at avoiding prior art.
  • Similar patents in the space involve compounds with comparable structures but differ in substitutions or synthesis methods.
  • The patent families extend protection globally, increasing licensing opportunities.
  • Challenges could arise based on prior art, but claims are supported by experimental data.
  • The patent is part of a broader strategic portfolio potentially impacting market exclusivity.

FAQs

1. How does US Patent 12,544,337 differ from prior art?
It claims specific chemical modifications not disclosed in earlier patents or scientific literature, especially regarding certain substituents and synthesis methods.

2. Are the claims broad enough to cover various derivatives?
The independent claims are specific but allow for dependent claims covering salts, stereoisomers, and formulations, creating a structured scope.

3. What are the key risks for infringing this patent?
Infringement risks depend on whether a compound or method falls within the scope of the claims, including derivatives and synthesis routes.

4. Can the patent be challenged for validity?
Yes, based on novelty or obviousness, especially if prior art discloses similar compounds or synthetic pathways.

5. How does this patent fit into a global strategy?
Its international filings suggest a plan for worldwide patent protection, useful in licensing or defending market exclusivity.


References

[1] U.S. Patent and Trademark Office. (2023). USPTO Patent Search Database.
[2] European Patent Office. (2023). EP Patent Database.
[3] GlobalData. (2023). Patent Portfolio Analysis Reports.
[4] WIPO. (2023). PatentScope Database.
[5] Raftery, D. (2015). Patent law and pharmaceutical innovation. Journal of Intellectual Property Law, 21(4), 304-320.

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Drugs Protected by US Patent 12,544,337

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 12,544,337 ⤷  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 12,544,337

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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