Viewing data from:

DIOVAN

NDA

VALSARTAN | N021283 | NOVARTIS PHARMACEUTICALS CORP

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

301 trials from ClinicalTrials.gov — 10 recruiting, 1 active, 227 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans NCT03938389	Phase 4	Active	Ohio State University	90	2020-02-25 → 2026-06
TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy NCT07139405	Phase 2	Not Yet Recruiting	Myopharm Limited	48	2026-09-01 → 2027-12-30
The Effect of Sacubitril/Valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients With Ischemic Heart Failure With Mid-range Ejection Fraction NCT05508035	Phase 3	Recruiting	John Paul II Hospital, Krakow	488	2023-07-13 → 2028-12
: Vascular Function in Health and Disease NCT02966665	Phase 1	Recruiting	Russell Richardson	420	2008-09 → 2026-08
Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot NCT07539298	Phase 2/3	Recruiting	Jonathan Beaudoin	50	2026-07-13 → 2029-12-01
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan NCT05194111	Phase 1/2	Recruiting	Virginia Commonwealth University	70	2022-08-11 → 2028-11-30
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study NCT04191681	Phase 4	Recruiting	The Cleveland Clinic	50	2019-11-08 → 2022-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania NCT06704633	Phase 4	Recruiting	Martin Rohacek	298	2026-06-30 → 2028-11-30

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$12.68

per ea

Lowest NADAC/Unit

$7.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078036034DIOVAN 320 MG TABLET	$12.68	EA	Brand	$0.1648	2026-08-19
00078035934DIOVAN 160 MG TABLET	$10.03	EA	Brand	$0.1123	2026-08-19
00078035834DIOVAN 80 MG TABLET	$9.33	EA	Brand	$0.0891	2026-08-19
00078042315DIOVAN 40 MG TABLET	$7.82	EA	Brand	$0.0973	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$176.58

Highest Price

$1077.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0358-34DIOVAN 80MG TAB	$633.02	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0358-34DIOVAN 80MG TAB	$791.73	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0359-34DIOVAN 160MG TAB	$680.63	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0359-34DIOVAN 160MG TAB	$851.39	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0360-34DIOVAN 320MG TAB	$861.17	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0360-34DIOVAN 320MG TAB	$1077.07	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0423-15DIOVAN 40MG TAB	$176.58	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0423-15DIOVAN 40MG TAB	$220.78	FSS	Novartis Pharmaceuticals Corporation	08/31/2026

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

API Supply Chain32 active DMFs17 inactive

28 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDVALSARTAN USP

DMF 182532005

JUBILANT BIOSYS LTDVALSARTAN USP

DMF 189672005

LUPIN LTDVALSARTAN USP

DMF 193012006

DR REDDYS LABORATORIES LTDVALSARTAN

DMF 203192007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDVALSARTAN USP (PROCESS II)

DMF 234912010

ALEMBIC PHARMACEUTICALS LTDVALSARTAN USP (PROCESS II)

DMF 235842010

NOVARTIS PHARMACEUTICALS CORPVALSARTAN DRUG SUBSTANCE

DMF 239022010

MACLEODS PHARMACEUTICALS LTDVALSARTAN USP

DMF 241782010

APITORIA PHARMA PRIVATE LTDVALSARTAN USP (PROCESS II)

DMF 245442011

TAPI NL BVVALSARTAN

DMF 247242011

DIVIS LABORATORIES LTDVALSARTAN USP

DMF 247972011

SECOND PHARMA CO LTDVALSARTAN

DMF 258482012

CADILA PHARMACEUTICALS LTDVALSARTAN USP (PROCESS 2)

DMF 261672012

IPCA LABORATORIES LTDVALSARTAN USP

DMF 288242016

HETERO LABS LTDVALSARTAN (PROCESS-III)

DMF 293922015

MSN LIFE SCIENCES PRIVATE LTDVALSARTAN USP

DMF 315982018

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDVALSARTAN

DMF 321752017

ZHUHAI RUNDU PHARMACEUTICAL CO LTDVALSARTAN

DMF 323282017

BIOCON LTDVALSARTAN DISODIUM

DMF 334272019

ZHUHAI RUNDU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM

DMF 334712019

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM

DMF 334752018

SYNTHON BVVALSARTAN DISODIUM

DMF 336482019

HARMAN FINOCHEM LTDVALSARTAN USP

DMF 342872019

ZYDUS LIFESCIENCES LTDVALSARTAN USP

DMF 348262020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDValsartan

DMF 355102020

MANKIND PHARMA LTDVALSARTAN DISODIUM

DMF 362032021

IOL CHEMICALS AND PHARMACEUTICALS LTDVALSARTAN USP

DMF 383392023

LAURUS LABS LTDVALSARTAN USP

DMF 384502023

CHANGZHOU PHARMACEUTICAL FACTORYVALSARTAN

DMF 410942025

LINHAI TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM (PROCESS II)

DMF 416222025

CHANGZHOU PHARMACEUTICAL FACTORYVALSARTAN DISODIUM

DMF 420152025

LINHAI TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM (PROCESS III)

DMF 425632025

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN USP

DMF 178972004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN

DMF 179092004

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveVALSARTAN DRUG SUBSTANCE

DMF 209392007

ALEMBIC PHARMACEUTICALS LTDInactiveValsartan USP ( PROCESS I)

DMF 211342007

AUROBINDO PHARMA LTDInactiveVALSARTAN USP (NON-STERILE DRUG SUBSTANCE)

DMF 218452008

CADILA PHARMACEUTICALS LTDInactiveVALSARTAN

DMF 221832008

IPCA LABORATORIES LTDInactiveVALSARTAN USP

DMF 226142010

CADILA HEALTHCARE LTDInactiveVALSARTAN USP

DMF 226842009

SIGNA SA DE CVInactiveVALSARTAN USP

DMF 231502009

HETERO LABS LTDInactiveVALSARTAN

DMF 248732011

ZHUHAI RUNDU PHARMACEUTICAL CO LTDInactiveVALSARTAN

DMF 255102011

HETERO LABS LTDInactiveVALSARTAN (PROCESS II)

DMF 263972012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVALSARTAN USP

DMF 266902012

ALEMBIC PHARMACEUTICALS LTDInactiveVALSARTAN USP (PROCESS III)

DMF 277802013

NINGBO MENOVO PHARMACEUTICAL CO LTDInactiveVALSARTAN

DMF 332542018

CHROMO LABORATORIES INDIA PRIVATE LTDInactiveVALSARTAN USP

DMF 335862019

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN USP

DMF 337702019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
May 12, 2026	SUPPL -62	View Letter (PDF)
Sep 8, 2021	SUPPL -59	View Letter (PDF)
Apr 22, 2021	SUPPL -58	View Letter (PDF)
Jun 13, 2019	SUPPL -53	View Letter (PDF)
Feb 7, 2017	SUPPL -50	View Letter (PDF)
Jul 28, 2015	SUPPL -46	View Letter (PDF)
Oct 1, 2014	SUPPL -44	View Letter (PDF)
Mar 19, 2014	SUPPL -42	View Letter (PDF)
Mar 19, 2014	SUPPL -41	View Letter (PDF)
Oct 9, 2012	SUPPL -39	View Letter (PDF)
Jul 30, 2012	SUPPL -37	View Letter (PDF)
Feb 29, 2012	SUPPL -35	View Letter (PDF)
Jan 23, 2012	SUPPL -36	View Letter (PDF)
Dec 14, 2011	SUPPL -33	View Letter (PDF)
Jun 7, 2011	SUPPL -32	View Letter (PDF)
Jun 17, 2009	SUPPL -27	View Letter (PDF)
Jan 9, 2008	SUPPL -24	View Letter (PDF)
Aug 22, 2007	SUPPL -21	View Letter (PDF)
Dec 4, 2006	SUPPL -18	View Letter (PDF)
Aug 8, 2005	SUPPL -11	View Letter (PDF)
Dec 6, 2004	SUPPL -12	View Letter (PDF)
Aug 14, 2002	SUPPL -1	View Letter (PDF)
Apr 5, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 18, 2001

No patent or exclusivity listings for this strength.

#002 — 160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 18, 2001

#003 — 320MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 18, 2001

#004 — 40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 2002