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
Albany Medical College	Phase 1/Phase 2
ARKAY Therapeutics	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

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	020818-005	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002

International Patents for DIOVAN HCT

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

Country	Patent Number	Title	Estimated Expiration
Indonesia	17553
Russian Federation	2009115778
Luxembourg	91676

Supplementary Protection Certificates for DIOVAN HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	98C004	Belgium		PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983	97C0050	France		PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513