HYZAAR Drug Patent Profile

Which patents cover Hyzaar, and what generic alternatives are available?

Hyzaar is a drug marketed by Organon and is included in one NDA.

The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for HYZAAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	16
Patent Applications:	4,274
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HYZAAR
Drug Sales Revenues:	Drug sales revenues for HYZAAR
What excipients (inactive ingredients) are in HYZAAR?	HYZAAR excipients list
DailyMed Link:	HYZAAR at DailyMed

See drug prices for HYZAAR

See drug sales revenues for HYZAAR

Recent Clinical Trials for HYZAAR

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

Sponsor	Phase
EMS	Phase 3
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
Azidus Brasil	Phase 1

See all HYZAAR clinical trials

Pharmacology for HYZAAR

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for HYZAAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	100 mg/12.5 mg	020387	1	2006-04-04
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	50 mg/12.5 mg and 100 mg/25 mg	020387	1	2004-05-24

US Patents and Regulatory Information for HYZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	AB	RX	Yes	No

Expired US Patents for HYZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995

International Patents for HYZAAR

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

Country	Patent Number	Title	Estimated Expiration
Portugal	89401	PROCESSO DE NOVOS DERIVADOS DE IMIDAZOIS SUBSTITUIDOS COM ACCAO BLOQUEADORA DO RECEPTOR DA ANGIOTENSINA II E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM EM ASSOCIACAO COM DIURETICOS E COMPOSTOS ANTI-INFLAMATORIOS NAO ESTEROIDES
Spain	2063734
Canada	2179067

Supplementary Protection Certificates for HYZAAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253310	96C0020	Belgium		PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419