BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Benazepril hydrochloride; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Ltd, and Validus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	6
Clinical Trials:	8
DailyMed Link:	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
TSH Biopharm Corporation Limited	Phase 4
Ranbaxy Laboratories Limited	N/A

See all BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	078794-003	Aug 21, 2014	AB	RX	No	No
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992		DISCN	Yes	No
Sun Pharm Inds Ltd	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	077483-004	Sep 8, 2005		DISCN	No	No
Sun Pharm Inds Ltd	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	077483-003	Sep 8, 2005		DISCN	No	No
Mylan Pharms Inc	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076612-001	Feb 11, 2004		DISCN	No	No

Expired US Patents for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-003	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-004	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-002	May 19, 1992