DIOVAN HCT Drug Patent Profile

When do Diovan Hct patents expire, and what generic alternatives are available?

Diovan Hct is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for DIOVAN HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	49
Patent Applications:	219
Drug Prices:	Drug price information for DIOVAN HCT
Drug Sales Revenues:	Drug sales revenues for DIOVAN HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIOVAN HCT
What excipients (inactive ingredients) are in DIOVAN HCT?	DIOVAN HCT excipients list
DailyMed Link:	DIOVAN HCT at DailyMed

See drug prices for DIOVAN HCT

See drug sales revenues for DIOVAN HCT

Recent Clinical Trials for DIOVAN HCT

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

Sponsor	Phase
ARKAY Therapeutics	Phase 1/Phase 2
Albany Medical College	Phase 1/Phase 2
LanZhou University	N/A

See all DIOVAN HCT clinical trials

Pharmacology for DIOVAN HCT

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

Paragraph IV (Patent) Challenges for DIOVAN HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	320 mg/12.5 mg and 320 mg/25 mg	020818	1	2007-02-07
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg	020818	1	2005-12-02

US Patents and Regulatory Information for DIOVAN HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-004	Apr 28, 2006	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006	AB	RX	Yes	Yes

Expired US Patents for DIOVAN HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-004	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006

International Patents for DIOVAN HCT

See the table below for patents covering DIOVAN HCT around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20090099020
Slovakia	178498	SOLID ORAL DOSAGE FORMS OF VALSARTAN
Germany	122010000024
Slovenia	1410797
Norway	20041287
South Korea	20080014149
Netherlands	970001

Supplementary Protection Certificates for DIOVAN HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	C980036	Netherlands		PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
0443983	C970001	Netherlands		PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
0443983	SPC/GB97/009	United Kingdom		PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
0443983	C00443983/02	Switzerland		PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016