Ertapenem Sodium

Sold as Invanz. Every FDA application for this active ingredient: 1 branded and 6 generic.

As of Nov 15, 2026, FDA lists 7 applications for Ertapenem Sodium (sold as Invanz), first approved Nov 21, 2001, with 3 new uses approved and 0 published complete response letters.

First approved: Nov 21, 2001
Applications: 7
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $75.8M
First approved in the EU: Apr 18, 2002

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Ertapenem	Part D	$74.5M	+3%	77,178
Ertapenem	Part B	$1.3M	-8%	6,970
Invanz	Part D	$7K	-38%	19

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ERTAPENEM 1 GRAM VIAL: $24.89 per unitGeneric · -18% in a year

Approvals in the EU (EMA)

First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ertapenem SUN, genericSUN Pharmaceutical Industries (Europe) B.V. · Jul 15, 2022
Invanz, new substanceMerck Sharp & Dohme B.V. · Apr 18, 2002

Clinical Trials

12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute PyelonephritisComplicated Urinary Tract Infections(cUTI), Acute Pyelonephritis · Wockhardt	Phase 2	Not yet recruiting	Sep 24, 2026
Combination Antibiotic Therapy for Staphylococcus Aureus BacteremiaStaphylococcus Aureus Bacteremia · Intermountain Health Care, Inc.	Phase 4	Recruiting	Jan 29, 2026
Cefotetan Therapy for Escherichia Coli InfectionsE Coli Infection, ESBL Producing E.Coli · Oregon Health and Science University	Phase 2	Recruiting	Jan 6, 2026
Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of CareFebrile Urinary Tract Infection · Uppsala University	Phase 4	Recruiting	Nov 19, 2025
Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?Staphylococcus Aureus Bacteremia · West Virginia University	Phase 4	Enrolling by invitation	Aug 29, 2025
PRevention Of Trauma-related Infections Through an Embedded Clinical Trials NetworkSurgical Site Infection · The University of Texas Health Science Center, Houston	Phase 4	Not yet recruiting	Apr 9, 2025
A Platform Trial for Gram Negative Bloodstream InfectionsGram-negative Bacteremia · Sunnybrook Health Sciences Centre	Not applicable	Recruiting	Aug 5, 2024
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIsUrinary Tract Infections, Bacteremia · Lund University	Phase 3	Recruiting	Feb 4, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 21, 2001	InvanzNDA 21337 · New molecular entity	Msd Sub Merck	31	Marketed
Apr 16, 2018	Ertapenem SodiumANDA 208790	Acs Dobfar Spa	4	Marketed
Jun 25, 2018	Ertapenem SodiumANDA 209133	Eugia Pharma	5	Marketed
Mar 19, 2019	Ertapenem SodiumANDA 207647	Savior Lifetec Corp	2	Marketed
Mar 26, 2021	Ertapenem SodiumANDA 212040	Gland	1	Marketed
May 2, 2023	Ertapenem SodiumANDA 209145	Sun Pharm	0	Discontinued
Oct 31, 2024	Ertapenem SodiumANDA 218067	Qilu Antibiotics	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA