ERTAPENEM SODIUM - Generic Drug Details

What are the generic drug sources for ertapenem sodium and what is the scope of patent protection?

Ertapenem sodium is the generic ingredient in two branded drugs marketed by Acs Dobfar Spa, Eugia Pharma, Gland Pharma Ltd, Savior Lifetec Corp, Sun Pharm, and Msd Sub Merck, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for ertapenem sodium. Fourteen suppliers are listed for this compound.

Summary for ERTAPENEM SODIUM

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	12
Patent Applications:	647
What excipients (inactive ingredients) are in ERTAPENEM SODIUM?	ERTAPENEM SODIUM excipients list
DailyMed Link:	ERTAPENEM SODIUM at DailyMed

Recent Clinical Trials for ERTAPENEM SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Albany College of Pharmacy and Health Sciences	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all ERTAPENEM SODIUM clinical trials

Pharmacology for ERTAPENEM SODIUM

Drug Class

Penem Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for ERTAPENEM SODIUM

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ERTAPENEM SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVANZ	Injection	ertapenem sodium	1 g/vial	021337	1	2012-12-21

US Patents and Regulatory Information for ERTAPENEM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790-001	Apr 16, 2018	AP	RX	No	No
Sun Pharm	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	209145-001	May 2, 2023		DISCN	No	No
Savior Lifetec Corp	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647-001	Mar 19, 2019	AP	RX	No	No
Gland Pharma Ltd	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	212040-001	Mar 26, 2021	AP	RX	No	No
Eugia Pharma	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	209133-001	Jun 25, 2018	AP	RX	No	No
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes

Expired US Patents for ERTAPENEM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001