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Valsartan - Generic Drug Details

What are the generic drug sources for valsartan and what is the scope of valsartan freedom to operate?

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-six 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:	36
Bulk Api Vendors:	106
Clinical Trials:	284
Patent Applications:	6,458
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for valsartan
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
➤ Sign Up	➤ Sign Up	320MG; 25MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	320MG; 12.5MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	160MG; 25MG	TABLET; ORAL

US Patents and Regulatory Information for valsartan

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	VALSARTAN	valsartan	TABLET;ORAL	090866-001	Jan 5, 2015	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ohm Labs Inc	VALSARTAN	valsartan	TABLET;ORAL	077492-002	Jun 26, 2014	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ohm Labs Inc	VALSARTAN	valsartan	TABLET;ORAL	077492-003	Jun 26, 2014	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for valsartan

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