Amiloride hydrochloride - Generic Drug Details

What are the generic drug sources for amiloride hydrochloride and what is the scope of freedom to operate?

Amiloride hydrochloride is the generic ingredient in five branded drugs marketed by Chartwell Rx, Par Pharm, Sigmapharm Labs Llc, Padagis Us, Barr, Rising, Teva, Watson Labs, 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.

Summary for amiloride hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	11
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	65
Patent Applications:	7,124
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in amiloride hydrochloride?	amiloride hydrochloride excipients list
DailyMed Link:	amiloride hydrochloride at DailyMed

Recent Clinical Trials for amiloride hydrochloride

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

Sponsor	Phase
Yale University	Phase 1
University of Utah	Early Phase 1
Center for Addiction and Mental Health	Early Phase 1

See all amiloride hydrochloride clinical trials

Pharmacology for amiloride hydrochloride

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

Medical Subject Heading (MeSH) Categories for amiloride hydrochloride

Acid Sensing Ion Channel Blockers

Diuretics

Epithelial Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for amiloride hydrochloride

C03DB	Other potassium-sparing agents
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for amiloride hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111-001	May 10, 1988	AB	RX	No	No
Padagis Us	MIDAMOR	amiloride hydrochloride	TABLET;ORAL	018200-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Par Pharm	HYDRO-RIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	070347-001	Dec 25, 1990		DISCN	No	No
Chartwell Rx	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073357-001	Nov 27, 1991		DISCN	No	No
Rising	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073209-001	Oct 31, 1991	AB	RX	No	Yes
Par Pharm	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346-001	Jan 22, 1986	AB	RX	No	Yes
Sigmapharm Labs Llc	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	079133-001	Jan 30, 2009	AB	RX	No	No