Viewing data from:

DIOVAN HCT

NDA

HYDROCHLOROTHIAZIDE; VALSARTAN | N020818 | NOVARTIS PHARMACEUTICALS CORP

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS PHARMACEUTICALS CORPORATION v. LUPIN LTD. et al 1:2012cv04552 1 patentANDA 78946valsartan and hydrochlorothiazide	D.N.J.	2012-07-20	Terminated 2012-09-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

27 trials from ClinicalTrials.gov, 27 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension NCT00241007	Phase 3	Completed	Novartis	836	2003-12 → 2005-03
Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension NCT00548067	Phase 3	Completed	Novartis	111	2007-09 → 2008-03
Valsartan Intensified Primary Care Reduction of Blood Pressure Study NCT00902304	Phase 4	Completed	Novartis Pharmaceuticals	2,337	2009-07 → 2011-07
Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension NCT00168779	Phase 4	Completed	Boehringer Ingelheim	1,185	2005-09 → 2006-07
Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone NCT00170989	Phase 3	Completed	Novartis	2,714	2004-09 → 2005-07
Action to Control Cardiovascular Risk in Diabetes (ACCORD)NCT00000620	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	10,251	1999-09 → 2012-12
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide NCT01767259	N/A	Completed	Damanhour University	24	2012-10 → 2012-12
Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension NCT01415505	Phase 3	Completed	Forest Laboratories	812	2011-08 → 2013-04
BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)NCT00546754	Phase 3	Completed	Organon and Co	808	2007-05-01 → 2009-05-01
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension NCT00500604	Phase 4	Completed	Sanofi	1,617	2007-07 → 2010-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$11.48

per ea

Lowest NADAC/Unit

$10.56

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078031534DIOVAN HCT 160-12.5 MG TAB	$11.48	EA	Brand	$0.1136	2026-06-17
00078031434DIOVAN HCT 80-12.5 MG TABLET	$10.56	EA	Brand	$0.1325	2026-01-07

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$712.79

Highest Price

$1392.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0383-34DIOVAN HCT 160MG/25MG TAB	$1098.62	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0383-34DIOVAN HCT 160MG/25MG TAB	$882.00	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0471-34DIOVAN HCT 320MG/12.5MG TAB	$1227.38	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0471-34DIOVAN HCT 320MG/12.5MG TAB	$985.84	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0472-34DIOVAN HCT 320MG/25MG TAB	$1392.44	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0472-34DIOVAN HCT 320MG/25MG TAB	$1114.60	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Diovan HCT (2024)

Total Spending

$6.5M

Total Claims

7,543

Beneficiaries

1,777

Avg Cost/Unit

$11.93

Spending Trend

$11.5M(2019)→$10.6M(2020)→$8.8M(2021)→$7.8M(2022)→$7.7M(2023)→$6.5M(2024)

YoY Change:-3.7%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Aug 24, 2020	SUPPL -80	View Letter (PDF)
Jun 13, 2019	SUPPL -75	View Letter (PDF)
Sep 26, 2014	SUPPL -64	View Letter (PDF)
Jun 3, 2014	SUPPL -60	View Letter (PDF)
Mar 19, 2014	SUPPL -58	View Letter (PDF)
Mar 19, 2014	SUPPL -62	View Letter (PDF)
Oct 9, 2012	SUPPL -56	View Letter (PDF)
Jul 30, 2012	SUPPL -54	View Letter (PDF)
Feb 17, 2012	SUPPL -51	View Letter (PDF)
Jan 23, 2012	SUPPL -53	View Letter (PDF)
Dec 14, 2011	SUPPL -46	View Letter (PDF)
Dec 14, 2011	SUPPL -49	View Letter (PDF)
Jun 9, 2011	SUPPL -47	View Letter (PDF)
Apr 23, 2010	SUPPL -43	View Letter (PDF)
Aug 5, 2008	SUPPL -36	View Letter (PDF)
Sep 11, 2007	SUPPL -35	View Letter (PDF)
Dec 4, 2006	SUPPL -32	View Letter (PDF)
May 2, 2006	SUPPL -27	View Letter (PDF)
Jul 15, 2005	SUPPL -24	View Letter (PDF)
Jun 2, 2004	SUPPL -16	View Letter (PDF)
Jun 2, 2004	ORIG -1	View Letter (PDF)
Jan 17, 2002	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 12.5MG;80MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 6, 1998

No patent or exclusivity listings for this strength.

#002 — 12.5MG;160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 6, 1998

#003 — 25MG;160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 17, 2002

#004 — 12.5MG;320MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 28, 2006

#005 — 25MG;320MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 28, 2006