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INVANZ

NDA

ERTAPENEM SODIUM | N021337 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:2015cv00415 1 patentANDA 207647ertapenem	E.D.N.C.	2015-08-21	Terminated 2018-02-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Qilu Pharma, Inc. FDA-2026-P-7530 · 6 docket documents Qilu Pharma, Inc. filed a suitability petition requesting that the FDA determine whether its proposed drug product is suitable for inclusion in an ANDA to establish bioequivalence to an NDA-approved reference drug product. The petition seeks FDA guidance on whether the proposed formulation, manufact	Suitability	2026-07-07	Open	Qilu Pharma, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

63 trials from ClinicalTrials.gov — 6 recruiting, 1 active, 40 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?NCT07148960	Phase 4	By Invitation	West Virginia University	300	2025-09-15 → 2027-07
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 Pyelonephritis NCT07840105	Phase 2	Not Yet Recruiting	Wockhardt	279	2026-09-30 → 2027-09-01
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia NCT04886284	Phase 2	Recruiting	Todd C. Lee MD MPH FIDSA	60	2024-05-20 → 2027-07
Cefotetan Therapy for Escherichia Coli Infections NCT07318584	Phase 2	Recruiting	Oregon Health and Science University	50	2026-06-26 → 2029-04
Antibiotic Prophylaxis in Patients Undergoing GVO NCT04140578	Phase 4	Recruiting	Taipei Veterans General Hospital, Taiwan	150	2017-01-28 → 2030-12-31
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections NCT01265784	Phase 2	Completed	Tetraphase Pharmaceuticals, Inc	143	2011-01 → 2012-05
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)NCT03358576	Phase 3	Completed	Iterum Therapeutics, International Limited	674	2018-09-18 → 2019-10-02
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.NCT00366249	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	1,061	2007-01 → 2009-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$24.89

per ea

Lowest NADAC/Unit

$24.89

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42023022185ERTAPENEM 1 GRAM VIAL	$24.89	EA	Generic	—	2026-10-21
42023022110ERTAPENEM 1 GRAM VIAL	$24.89	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$20.56

Highest Price

$232.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42023-0221-10ERTAPENEM 1GM/VIL INJ	$20.56	Big4	Endo USA, Inc.	09/30/2026
42023-0221-10ERTAPENEM 1GM/VIL INJ	$232.16	FSS	Endo USA, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Invanz (2024)

Total Spending

$11K

Total Claims

Beneficiaries

Avg Cost/Unit

$46.53

Spending Trend

$3.5M(2019)→$463K(2020)→$187K(2021)→$97K(2022)→$14K(2023)→$11K(2024)

YoY Change:-36.3%

5yr CAGR:+28.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Ertapenem (2024)

Total Spending

$1.4M

Total Claims

59,354

Beneficiaries

6,668

ASP Price

$11.50

Spending Trend

$7.3M(2019)→$5.0M(2020)→$4.3M(2021)→$2.7M(2022)→$1.9M(2023)→$1.4M(2024)

YoY Change:-15.6%

5yr CAGR:-25.2%

HCPCS: J1335 — Injection, ertapenem sodium, 500 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain8 active DMFs3 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SOLARA ACTIVE PHARMA SCIENCES LTDERTAPENEM SODIUM

DMF 283912014

ACS DOBFAR SPAERTAPENEM SODIUM

DMF 291022015

APITORIA PHARMA PRIVATE LTDERTAPENEM SODIUM

DMF 303112016

SHANDONG ANHONG PHARMACEUTICAL CO LTDERTAPENEM SODIUM

DMF 307092016

GLAND PHARMA LTDERTAPENEM SODIUM

DMF 324242018

SHANDONG ANHONG PHARMACEUTICAL CO LTDERTAPENEM SODIUM (PROCESS I)

DMF 372322022

JILIN ASYMCHEM PHARMACEUTICALS CO LTDERTAPENEM SODIUM

DMF 374632023

GLAND CHEMICALS PRIVATE LTDERTAPENEM SODIUM

DMF 401912024

PFIZER HEALTHCARE INDIA PVT LTDInactiveERTAPENEM SODIUM

DMF 273482013

ASYMCHEM LABORATORIES FUXIN CO LTDInactiveERTAPENEM SODIUM

DMF 294732015

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveERTAPENEM SODIUM

DMF 301232016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2022	SUPPL -51	View Letter (PDF)
Dec 23, 2020	SUPPL -49	View Letter (PDF)
Sep 23, 2019	SUPPL -48	View Letter (PDF)
Dec 21, 2018	SUPPL -47	View Letter (PDF)
Sep 14, 2018	SUPPL -46	View Letter (PDF)
Sep 20, 2017	SUPPL -45	View Letter (PDF)
Oct 2, 2014	SUPPL -42	View Letter (PDF)
Jul 26, 2013	SUPPL -41	View Letter (PDF)
Mar 5, 2012	SUPPL -38	View Letter (PDF)
Jul 25, 2011	SUPPL -31	View Letter (PDF)
May 27, 2010	SUPPL -34	View Letter (PDF)
Jan 25, 2010	SUPPL -30	View Letter (PDF)
Nov 10, 2009	SUPPL -33	View Letter (PDF)
Mar 26, 2008	SUPPL -28	View Letter (PDF)
Nov 19, 2007	SUPPL -26	View Letter (PDF)
Aug 14, 2006	SUPPL -21	View Letter (PDF)
Oct 19, 2005	SUPPL -19	View Letter (PDF)
May 20, 2005	SUPPL -18	View Letter (PDF)
Jan 26, 2005	SUPPL -17	View Letter (PDF)
Sep 10, 2004	SUPPL -15	View Letter (PDF)
May 26, 2004	SUPPL -14	View Letter (PDF)
May 4, 2004	SUPPL -13	View Letter (PDF)
Nov 9, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1GM BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Nov 21, 2001

No patent or exclusivity listings for this strength.