AMILORIDE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for amiloride hydrochloride and what is the scope of patent protection?

Amiloride hydrochloride is the generic ingredient in five branded drugs marketed by Chartwell Rx, Endo Operations, Sigmapharm Labs Llc, Padagis Us, Barr, Rising, Teva, Watson Labs, Par Pharm, and Merck, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for amiloride hydrochloride. Four suppliers are listed for this compound.

Sponsor

Phase

Yale University

Phase 1

Venkata Yellepeddi

Early Phase 1

University of Utah

Early Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	MIDAMOR	amiloride hydrochloride	TABLET;ORAL	018200-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073334-001	Jul 19, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073357-001	Nov 27, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	10
NDAs:	11
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	65
Patent Applications:	1,892
What excipients (inactive ingredients) are in AMILORIDE HYDROCHLORIDE?	AMILORIDE HYDROCHLORIDE excipients list
DailyMed Link:	AMILORIDE HYDROCHLORIDE at DailyMed

Drug Class	Potassium-sparing Diuretic
Physiological Effect	Decreased Renal K+ Excretion Increased Diuresis