ZESTORETIC Drug Patent Profile

Which patents cover Zestoretic, and when can generic versions of Zestoretic launch?

Zestoretic is a drug marketed by Almatica and is included in one NDA.

The generic ingredient in ZESTORETIC is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for ZESTORETIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	151
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZESTORETIC
What excipients (inactive ingredients) are in ZESTORETIC?	ZESTORETIC excipients list
DailyMed Link:	ZESTORETIC at DailyMed

See drug prices for ZESTORETIC

See drug sales revenues for ZESTORETIC

Recent Clinical Trials for ZESTORETIC

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

Sponsor	Phase
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
IPCA Laboratories Ltd.	Phase 1

See all ZESTORETIC clinical trials

Pharmacology for ZESTORETIC

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 ZESTORETIC

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

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 ZESTORETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-003	Nov 18, 1993	AB	RX	Yes	No
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990	AB	RX	Yes	No
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-002	Jul 20, 1989	AB	RX	Yes	No

Expired US Patents for ZESTORETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-003	Nov 18, 1993

International Patents for ZESTORETIC

See the table below for patents covering ZESTORETIC around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P940134	PROCESS FOR THE PREPARATION OF CARBOXYALKYL DIPEPTIDE DERIVATIVES
Czechoslovakia	237326	METHOD OF PREPARATION OF CARBOXYALKYLDIPEPTIDE
Canada	1300313	DERIVES D'AMINO-ACIDES (AMINO ACID DERIVATIVES)

Supplementary Protection Certificates for ZESTORETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015