# US 12,109,197 B2 · Combinations of β-lactam compounds and probenecid and uses thereof

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- Number: US 12,109,197 B2
- Document ID: US12109197B2
- Status: Granted
- Kind: B2
- Application number: 18/065,400
- Filed: 2022-12-13
- Published: 2023-07-13
- Granted: 2024-10-08
- Earliest claimed: 2018-06-07
- Assignees: Iterum Therapeutics International Limited
- Applicants: Iterum Therapeutics International Limited
- Inventors: Michael Dunne
- Web page: https://patentgrep.com/patent/US12109197B2

## CPC

- A61K 31/431: containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 9/2004: {Excipients; Inactive ingredients}
- A61K 31/145: having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2) (isothiourea A61K31/155)
- A61K 31/195: having an amino group
- A61K 31/407: condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
- A61K 31/424: condensed with heterocyclic ring systems, e.g. clavulanic acid
- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 31/4353: ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/5365: ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/545: Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula: [IMAGE cpc-sch-A61K-0953.gif] , e.g. cephalosporins, {cefaclor, or cephalexine}
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present disclosure relates to combinations of a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease via administering to subjects in need thereof a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof.

## Claims

### Claim 1

A method of treating or preventing uncomplicated urinary tract infection, comprising:
administering to a subject in need thereof from 400 mg to 600 mg of a β-lactam compound or a pharmaceutically acceptable salt thereof, and from 400 mg to 600 mg of probenecid or a pharmaceutically acceptable salt thereof, simultaneously twice daily for from 5 days to 10 days,
wherein the β-lactam compound is:
or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the β-lactam compound or the pharmaceutically acceptable salt thereof, and probenecid or the pharmaceutically acceptable salt thereof, are administered by oral administration.

### Claim 3 (depends on 1)

The method of claim 1, wherein an oral co-formulation comprising the β-lactam compound or the pharmaceutically acceptable salt thereof and probenecid or the pharmaceutically acceptable salt thereof is administered.

### Claim 4 (depends on 3)

The method of claim 3, wherein a tablet comprising the ß-lactam compound or the pharmaceutically acceptable salt thereof and probenecid or the pharmaceutically acceptable salt thereof is administered.

### Claim 5 (depends on 1)

The method of claim 1, wherein a food is administered to the subject during the administration of the β-lactam compound or the pharmaceutically acceptable salt thereof and probenecid or the pharmaceutically acceptable salt thereof.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject in need thereof is a human.

### Claim 7 (depends on 1)

The method of claim 1, wherein the β-lactam compound is selected from the group consisting of:
or pharmaceutically acceptable salts thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein the β-lactam compound is:
or a pharmaceutically acceptable salt thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the β-lactam compound is:
or a pharmaceutically acceptable salt thereof.

### Claim 10 (depends on 1)

The method of claim 1, wherein the β-lactam compound or the pharmaceutically acceptable salt thereof, and probenecid or the pharmaceutically acceptable salt thereof, are administered for 5 days.