Is there a generic for Ertapenem sodium?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Ertapenem sodium, referencing the brand INVANZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ertapenem sodium?

INVANZ (NDA 021337, MSD SUB MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ertapenem sodium are approved?

Ertapenem sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ertapenem sodium

Ertapenem sodium is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INVANZ · NDA 021337

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
INVANZRLD	MSD SUB MERCK	NDA 021337	AP	Nov 21, 2001

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
ERTAPENEM SODIUM	QILU ANTIBIOTICS	ANDA 218067	AP	Oct 31, 2024
ERTAPENEM SODIUM	SUN PHARM	ANDA 209145	—	May 02, 2023
ERTAPENEM SODIUM	GLAND	ANDA 212040	AP	Mar 26, 2021
ERTAPENEM SODIUM	SAVIOR LIFETEC CORP	ANDA 207647	AP	Mar 19, 2019
ERTAPENEM SODIUM	EUGIA PHARMA	ANDA 209133	AP	Jun 25, 2018
ERTAPENEM SODIUM	ACS DOBFAR SPA	ANDA 208790	AP	Apr 16, 2018

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ertapenem sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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