AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Amiloride hydrochloride; hydrochlorothiazide is the generic ingredient in three branded drugs marketed by Barr, Chartwell Rx, Rising, Teva, Watson Labs, Par Pharm, and Merck, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	2
Clinical Trials:	12
DailyMed Link:	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Hospital de Clinicas de Porto Alegre	Phase 3
Instituto de Cardiologia do Rio Grande do Sul	Phase 3
Guangdong Provincial People's Hospital	Phase 4

See all AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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; HYDROCHLOROTHIAZIDE

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
Barr	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111-001	May 10, 1988	AB	RX	No	No
Watson Labs	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073334-001	Jul 19, 1991		DISCN	No	No
Teva	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	070795-001	Apr 17, 1988		DISCN	No	No
Rising	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073209-001	Oct 31, 1991	AB	RX	No	Yes
Chartwell Rx	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073357-001	Nov 27, 1991		DISCN	No	No
Par Pharm	HYDRO-RIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	070347-001	Dec 25, 1990		DISCN	No	No

Expired US Patents for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982