Viewing data from:

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	NCED	2015-08-21	Terminated 2018-02-01	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Invanz (2023)

Total Spending

$14K

Total Claims

Beneficiaries

Avg Cost/Unit

$73.03

Spending Trend

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

YoY Change:+318.3%

5yr CAGR:+28.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Ertapenem (2023)

Total Spending

$1.9M

Total Claims

62,821

Beneficiaries

6,589

ASP Price

—

HCPCS: J1335 — Injection, ertapenem sodium, 500 mg

Source: CMS Medicare Part B Spending by Drug (2023). 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.