ETHACRYNATE SODIUM - Generic Drug Details

What are the generic sources for ethacrynate sodium and what is the scope of freedom to operate?

Ethacrynate sodium is the generic ingredient in two branded drugs marketed by Bausch, Endo Operations, Mylan Institutional, Sterimax, and Zydus Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ethacrynate sodium. Five suppliers are listed for this compound.

Summary for ETHACRYNATE SODIUM

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	510
What excipients (inactive ingredients) are in ETHACRYNATE SODIUM?	ETHACRYNATE SODIUM excipients list
DailyMed Link:	ETHACRYNATE SODIUM at DailyMed

Pharmacology for ETHACRYNATE SODIUM

Drug Class	Loop Diuretic
Physiological Effect	Increased Diuresis at Loop of Henle

US Patents and Regulatory Information for ETHACRYNATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sterimax	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	208663-001	Jun 9, 2020	AP	RX	No	No
Endo Operations	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	205473-001	Jul 29, 2015	AP	RX	No	No
Mylan Institutional	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	204634-001	Aug 23, 2016	AP	RX	No	No
Bausch	EDECRIN	ethacrynate sodium	INJECTABLE;INJECTION	016093-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Zydus Pharms	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	207758-001	Nov 17, 2017	AP	RX	No	No