Prescription medicine
Probenecid and sulopenem etzadroxil Brand names: Orlynvah
Probenecid and sulopenem etzadroxil (Orlynvah) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the probenecid and sulopenem etzadroxil FDA label on DailyMed (effective December 6, 2025, ITERUM THERAPEUTICS US LIMITED); the NDA 213972 record on Drugs@FDA; every probenecid and sulopenem etzadroxil label on DailyMed.
Highlights of the record
FDA label of December 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
Forms and strengths
- 500 mg / 500 mg
Film-coated tablet.
On the market
- Earliest approval on file
- October 25, 2024 Orlynvah, Iterum Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 23, 2039 Orlynvah tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2 through July 30, 2026
What is probenecid and sulopenem etzadroxil used for?
From the label: indications and usageORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ( 1.1 ) Limitations of Use ORLYNVAH is not indicated for the treatment of: Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. […]
Conditions named in the indications of probenecid and sulopenem etzadroxil's FDA labels, with every medicine labeled for each:
From other probenecid and sulopenem etzadroxil labelsUrinary tract infections: Uncomplicated Urinary Tract Infections ORLYNVAH is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult …
Source: FDA drug label (ORLYNVAH), ITERUM THERAPEUTICS US LIMITED, effective December 6, 2025 (SPL set 24c451c0-4cfb-37f3-e063-6394a90a895e), via openFDA; the full label on DailyMed
Is there a generic for probenecid and sulopenem etzadroxil (Orlynvah)?
No generic probenecid and sulopenem etzadroxil is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Orlynvah tablets: the compound patent runs to June 3, 2029, and the last listed entry to December 23, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the probenecid and sulopenem etzadroxil label say about other medicines?
The probenecid and sulopenem etzadroxil label names 11 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | Valproic Acid No valproic acid dosage adjustment is recommended when used concomitantly with ORLYNVAH. |
| Indomethacin | drug interactions | Concomitant Drug/Drug Class: Indomethacin; Effect on Drug Concentration: ↑ indomethacin; Recommendation: May increase the risk of adverse reactions. Refer to drug-specific prescribing information for dosage adjustment instructions. |
| Ketoprofen | drug interactions | DRUG INTERACTIONS Ketoprofen: Concomitant use is not recommended ( 7.1 ) See full prescribing information for additional clinically significant drug interactions with ORLYNVAH |
| Ketorolac | contraindications | Known uric acid kidney stones [see Warnings and Precautions ( 5.3 )] Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions ( 7.1 )] Patients with a history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta- lactam … |
| Lorazepam | drug interactions | Concomitant Drug/Drug Class: Lorazepam; Effect on Drug Concentration: ↑ lorazepam; Recommendation: Follow the recommended lorazepam dosage modifications outlined in its prescribing information. |
| Methotrexate | drug interactions | Concomitant Drug/Drug Class: Methotrexate; Effect on Drug Concentration: ↑ methotrexate; Recommendation: If concomitant use cannot be avoided, monitor more frequently for adverse reactions associated with methotrexate as recommended in its prescribing information. |
| Naproxen | drug interactions | Concomitant Drug/Drug Class: Naproxen; Effect on Drug Concentration: ↑ naproxen; Recommendation: May increase the risk of adverse reactions. Refer to drug-specific prescribing information for dosage adjustment instructions. |
| Rifampin | drug interactions | Concomitant Drug/Drug Class: Rifampin; Effect on Drug Concentration: ↑ rifampin; Recommendation: Monitor more frequently for adverse reactions associated with rifampin as recommended in its prescribing information. |
| Theophylline | drug interactions | Falsely high readings for theophylline have been reported in an in vitro study, using the Schack and Waxler technique, when therapeutic concentrations of theophylline and probenecid (a component of ORLYNVAH) were added to human plasma. |
| Tromethamine | contraindications | Known uric acid kidney stones [see Warnings and Precautions ( 5.3 )] Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions ( 7.1 )] Patients with a history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta- lactam … |
| Valproic acid | drug interactions | Valproic Acid No valproic acid dosage adjustment is recommended when used concomitantly with ORLYNVAH. |
Check probenecid and sulopenem etzadroxil against other medicines
Source: FDA drug label (ORLYNVAH), ITERUM THERAPEUTICS US LIMITED, effective December 6, 2025 (SPL set 24c451c0-4cfb-37f3-e063-6394a90a895e), via openFDA; the full label on DailyMed
What do FAERS reports show for probenecid and sulopenem etzadroxil?
The FDA Adverse Event Reporting System holds 2 reports that list probenecid and sulopenem etzadroxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as probenecid and sulopenem etzadroxil?
9 other medicines are given the same way (oral) and in the same FDA class as probenecid and sulopenem etzadroxil or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxycycline | Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin and clavulanate | Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Nitrofurantoin | Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Minocycline | Urinary tract infections | 21 labelers | $0.343 per capsule 100 mg capsule | No current entry |
| Methenamine | Urinary tract infections | 10 labelers | $0.313 per tablet 1 g tablet | No current entry |
| Fosfomycin | Urinary tract infections | 10 labelers | $26.22 per unit 3 g sachet | No current entry |
| Sulfadiazine | Urinary tract infections | 2 labelers | $15.06 per tablet 500 mg tablet | No current entry |
| Gepotidacin | Urinary tract infections | none listed | $91.40 per tablet 750 mg tablet | No current entry |
Every medicine labeled for the same conditions as probenecid and sulopenem etzadroxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to probenecid and sulopenem etzadroxil
- 9 medicines for the same use
- Probenecid and sulopenem etzadroxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other