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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 · 5 docket documents Qilu Pharma, Inc., acting as the US Agent for Qilu Antibiotics Pharmaceutical Co., Ltd., filed this suitability petition under section 505(j)(2)(c) requesting FDA determination that Ertapenem for Injection, 500 mg/vial, is suitable for submission in an ANDA, with the Reference Listed Drug being INVA	Suitability	2026-07-07	Open	Qilu Pharma, Inc.

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

Clinical Trials

58 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 39 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
Antibiotic Prophylaxis in Patients Undergoing GVO NCT04140578	Phase 4	Recruiting	Taipei Veterans General Hospital, Taiwan	150	2017-01-28 → 2030-12-31
Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects NCT01073059	Phase 1	Completed	Chonbuk National University	10	2009-08
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)NCT03788967	Phase 3	Completed	Spero Therapeutics	1,372	2019-06-03 → 2020-05-27
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)NCT00090272	Phase 3	Completed	Merck Sharp & Dohme LLC	952	2002-04 → 2005-03
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection NCT01069900	Phase 3	Completed	Bayer	458	2010-07-21 → 2015-01-21
Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion NCT01148771	Phase 4	Completed	Hartford Hospital	12	2010-08 → 2010-10
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)NCT01014013	Phase 3	Completed	Merck Sharp & Dohme LLC	271	2008-04 → 2009-02
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration NCT02041767	Phase 4	Completed	Assistance Publique - Hôpitaux de Paris	20	2013-12 → 2015-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$30.16

per ea

Lowest NADAC/Unit

$30.16

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42023022185ERTAPENEM 1 GRAM VIAL	$30.16	EA	Generic	—	2026-06-17
42023022110ERTAPENEM 1 GRAM VIAL	$30.16	EA	Generic	—	2026-06-17

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	$232.16	FSS	Endo USA, Inc.	09/30/2026
42023-0221-10ERTAPENEM 1GM/VIL INJ	$20.56	Big4	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.