ERTAPENEM SODIUM

Post-LOE

ertapenem

Gland Pharma

ANDAINTRAMUSCULAR, INTRAVENOUSINJECTABLE

Approved

Mar 2021

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ERTAPENEM SODIUM (ertapenem) by Gland Pharma is [see clinical pharmacology ()]. Approved for older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see dosage, administration ()], older) with complicated intra-abdominal infections due to escherichia coli and 28 more indications. First approved in 2021.

Drug data last refreshed 19h ago

Mechanism of Action

[see Clinical Pharmacology ()].

Indications (30)

Administration ()]older) with complicated intra-abdominal infections due to Escherichia coli Clostridium clostridioforme

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT05645757Phase 1Completed

Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)

Started Apr 2023

54 enrolled

Bacterial Infection

NCT03788967Phase 3Completed

Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Started Jun 2019

1,372 enrolled

Complicated Urinary Tract InfectionAcute Pyelonephritis

NCT03358576Phase 3Completed

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Started Sep 2018

674 enrolled

Intra Abdominal Infections

NCT03357614Phase 3Completed

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Started Sep 2018

1,395 enrolled

Complicated Urinary Tract Infections

NCT02041767Phase 4Completed

Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

Started Dec 2013

20 enrolled

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection