Fosinopril sodium; hydrochlorothiazide - Generic Drug Details

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

Fosinopril sodium; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for fosinopril sodium; hydrochlorothiazide

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
DailyMed Link:	fosinopril sodium; hydrochlorothiazide at DailyMed

Recent Clinical Trials for fosinopril sodium; hydrochlorothiazide

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

Sponsor	Phase
Ranbaxy Laboratories Limited	N/A

See all fosinopril sodium; hydrochlorothiazide clinical trials

Pharmacology for fosinopril sodium; hydrochlorothiazide

Drug Class	Angiotensin Converting Enzyme Inhibitor Thiazide Diuretic
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for fosinopril sodium; hydrochlorothiazide

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

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for fosinopril sodium; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-002	Jul 9, 2009	AB	RX	No	No
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-001	Jul 9, 2009	AB	RX	No	No
Aurobindo Pharma	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245-002	Jul 9, 2009	AB	RX	No	Yes
Avet Lifesciences	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079025-002	Sep 17, 2010		DISCN	No	No
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	077144-001	Aug 16, 2005		DISCN	No	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076608-002	Dec 3, 2004		DISCN	No	No

Expired US Patents for fosinopril sodium; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994