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Valsartan - Generic Drug Details

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What are the generic sources for valsartan and what is the scope of valsartan patent protection?

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent Pharms Ltd, Unichem Labs Ltd, and Watson Labs Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for valsartan. Thirty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for valsartan

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	18
Drug Master File Entries:	37
Suppliers / Packagers:	37
Bulk Api Vendors:	110
Clinical Trials:	272
Patent Applications:	6,405
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valsartan
DailyMed Link:	valsartan at DailyMed

Pharmacology for valsartan

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for valsartan

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Synonyms for valsartan

(2S)-3-Methyl-2-(pentanoyl-((4-(2-(2H-tetrazol-5-yl)phenyl)phenyl)methyl)amino)butanoic acid

(2S)-3-METHYL-2-(PENTANOYL-[2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YLMETHYL]-AMINO)-BUTYRIC ACID

(2S)-3-methyl-2-[N-({4-[2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic acid

(2S)-3-methyl-2-[N-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic acid

(2S)-3-methyl-2-[pentanoyl-[[4-[2-(1H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid

(2S)-3-methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid

(2S)-3-Methyl-2-{N-pentanoyl-N'-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butanoic acid

(2S)-3-Methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

(5)-2-{N-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]pentanamido}-3-methylbutanoic acid

(S)-2-(N-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoic acid

(s)-2-(n-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)pentanamido)-3-methylbutanoic acid

(S)-3-METHYL-2-(PENTANOYL-[2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YLMETHYL]-AMINO)-BUTYRIC ACID

(s)-3-methyl-2-(pentanoyl-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino)-butyric acid 137862-53-

(S)-3-METHYL-2-[N-((4-[2-(2H-1,2,3,4-TETRAZOL-5-YL)PHENYL]PHENYL)METHYL)PENTANAMIDO]BUTANOIC ACID

(s)-3-methyl-2-[N-({4-[2-(2h-1,2,3,4-tetrazol-5-yl) phenyl]phenyl}methyl)pentanamido]butanoic acid

(S)-3-methyl-2-[N-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic acid

(s)-3-methyl-2-{pentanoyl-[-2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

(S)-3-Methyl-2-{pentanoyl-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

(S)-3-Methyl-2-{pentanoyl-[2''-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

(S)-3-Methyl-2-{pentanoyl-[2''-(2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

(S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-pentanoyl-N-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amine

(S)-N-(1-Carboxy-2-methyl-prop-1-yl)-N-pentanoyl-N-[2'-(1H-tetrazol-5-yl)biphenyl-4-ylmethyl]-amine

(S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-pentanoyl-N-[2'(1H-tetrazol-5-yl)biphenyl-4-yl-methyl]amine

(S)-N-BUTYRYL-N-([2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL]METHYL)-VALINE

(S)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine

[3H]valsartan

137862-53-4

137863-60-6

2-{[2''-(2,3-Dihydro-1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-pentanoyl-amino}-3-methyl-butyric acid

3-Methyl-2-{((S)-pentanoyl)-[2''-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric acid

3-Methyl-2-{pentanoyl-[2''-(1H-tetrazol-5-yl)-biphenyl-4-yl]-amino}-butyric acid

4997-EP2270011A1

4997-EP2272841A1

4997-EP2277879A1

4997-EP2295406A1

4997-EP2295422A2

4997-EP2298772A1

4997-EP2298776A1

4997-EP2298779A1

4997-EP2301923A1

4997-EP2301931A1

4997-EP2301936A1

4997-EP2305219A1

4997-EP2308562A2

4997-EP2308839A1

62V534

80M03YXJ7I

AB0013966

AB00639940_09

AB00639940_11

AB00639940-06

AB00639940-08

AB07510

AB2000354

AC-4543

AC1L1U1M

AC1Q5QIK

ACT02671

ACWBQPMHZXGDFX-QFIPXVFZSA-N

AK-58790

AKOS015914315

AKOS015994698

AM90287

Ambap137862-53-4

AN-7255

ANGIOTAN

ANW-49040

Aventis brand of valsartan

AX8018200

BC204156

BDBM50049186

BG0645

BIDD:GT0345

Bio-0796

BR-58790

BRD-K45158365-001-02-3

BSPBio_003501

C24H29N5O3

cardopan

CCG-101028

CCG-221275

CEPA brand of valsartan

CGP 48933

CGP-48933

CHEBI:9927

CHEMBL1069

CPD000466318

CS-1967

D00400

D04HSR

D06UDG

DB00177

Diovan

Diovan (TN)

Diovan, Valsartan

DR002693

DS-1248

EC 604-045-2

Esteve brand of valsartan

Exforge

EZR-104

FT-0631156

GP8514

GTPL3937

GTPL593

HE308708

HMS1922L21

HMS2051L12

HMS2093K22

HMS2232F05

HMS3651E04

HSDB 7519

HY-18204

I14-41498

I997

J-007068

J10013

Kalpress

KBio2_002287

KBio2_004855

KBio2_007423

KBio3_003006

KBioGR_001078

KBioSS_002289

KS-00000ISS

KS-1194

L-Valine, N-(1-oxopentyl)-N-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-

L-Valine, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

L-Valine, N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-(9CI)

L-Valine, N-(1-oxopentyl)-N-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

L-Valsartan

Lacer brand of valsartan

LS-161334

MCULE-6728882368

MFCD00865840

Miten

MLS000759423

MLS001424088

MolPort-002-507-854

MolPort-003-666-608

N-?(1-?OXOPENTYL)-?N-?[[2'-?(2H-?TETRAZOL-?5-?YL)[1,?1'-?BIPHENYL]-?4-?YL]METHYL]-?L-?VALINE

N-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-N-pentanoyl-L-valine

N-(1-oxopentyl)-N-[[2'-(1h-tetrazol-5-yl) [1,1'-bi-phenyl]-4-yl]methyl]-l-valine

N-(1-Oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-(L)-valine

N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine

N-(1-OXOPENTYL)-N-[[2'-(2H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-L-VALINE

N-(p-(o-1H-Tetrazol-5-ylphenyl)benzyl)-N-valeryl-L-valine

N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine

N-PENTANOYL-N-([2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL]METHYL)-L-VALINE

N-pentanoyl-N-{[2'-(1H-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-L-valine

N-pentanoyl-N-{[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valine

N-pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine

N-valeryl-N-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)valine

N-Valeryl-N-[2'-(1H-tetrazol-5-yl)biphenyl-4-ylmethyl]-L-valine

N-Valeryl-N-[2'-(5-tetrazolyl)biphenyl-4-ylmethyl]-L-valine

NC00278

Nisis

Novartis brand of valsartan

NSC-758927

NSC758927

Pharmakon1600-01505209

Prexxartan

Prexxartan (oral solution)

Provas

PubChem9865

RTR-031794

S-6418

s1894

SAM001246581

Sanol brand of valsartan

SBI-0206738.P001

SC-00971

SCHEMBL2542

Schwarz brand of valsartan

SMR000466318

SPBio_001260

Spectrum_001796

SPECTRUM1505209

Spectrum2_001120

Spectrum3_001831

Spectrum4_000749

Spectrum5_001582

ST2408288

Tareg

TL8000869

TR-031794

UNII-80M03YXJ7I

VA11929

VAL-489

Valpression

Vals

Valsarran

valsartan (Diovan)

Valsartan (JAN/USAN/INN)

Valsartan (JP17/USAN/INN)

Valsartan [USAN:INN]

Valsartan [USAN:USP:INN:BAN]

Valsartan for peak identification, European Pharmacopoeia (EP) Reference Standard

Valsartan for system suitability, European Pharmacopoeia (EP) Reference Standard

Valsartan, >=98% (HPLC)

Valsartan, European Pharmacopoeia (EP) Reference Standard

Valsartan, pharmaceutical secondary standard; traceable to USP and PhEur

Valsartan, United States Pharmacopeia (USP) Reference Standard

valsartanin

Valtan

Valtan (TN)

Valzaar

Valzaar (TN)

Varexan

walsartan

ZINC3875259

Tentative approvals for VALSARTAN

Applicant	Application No.	Strength	Dosage Form
		80MG; 12.5MG	TABLET; ORAL
		320MG; 25MG	TABLET; ORAL
		320MG; 12.5MG	TABLET; ORAL

US Patents and Regulatory Information for valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	VALSARTAN	valsartan	TABLET;ORAL	203311-002	Jan 5, 2015	AB	RX	No	No
Alembic Pharms Ltd	VALSARTAN	valsartan	TABLET;ORAL	091367-002	Jan 5, 2015	AB	RX	No	No
Mylan Pharms Inc	VALSARTAN	valsartan	TABLET;ORAL	090866-001	Jan 5, 2015	AB	RX	No	No
Amneal Pharms	VALSARTAN	valsartan	TABLET;ORAL	204011-004	Jan 11, 2016	AB	RX	No	No

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Expired US Patents for valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996

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