Valsartan - Generic Drug Details

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

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

There are forty drug master file entries for valsartan. Thirty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for valsartan

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	19
Drug Master File Entries:	40
Suppliers / Packagers:	30
Bulk Api Vendors:	123
Clinical Trials:	306
Patent Applications:	6,501
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for valsartan
Drug Sales Revenues:	Drug sales revenues for valsartan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valsartan
DailyMed Link:	valsartan at DailyMed

See drug prices for valsartan

See drug sales revenues for valsartan

Recent Clinical Trials for valsartan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Zagreb	Phase 4
University of Alabama at Birmingham	Phase 2
Eli Lilly and Company	Phase 1

See all valsartan clinical trials

Recent Litigation for valsartan

Identify potential future generic entrants

District Court Litigation

Case Name	Date
NOVARTIS PHARMACEUTICALS CORPORATION v. LUPIN LTD.	2012-07-20
Novartis Pharmaceuticals Corporation v. Lupin Ltd.	2012-05-14
Walgreen CO v. Novartis Pharmaceuticals Corporation

See all valsartan litigation

Generic filers with tentative approvals for VALSARTAN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	320MG; 25MG	TABLET; ORAL
Start Trial	Start Trial	320MG; 12.5MG	TABLET; ORAL
Start Trial	Start Trial	160MG; 25MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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-[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-[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
(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-[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-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
AN-7255
ANW-49040
AX8018200
BC204156
BCP05184
BDBM50049186
BG0645
BIDD:GT0345
BR-58790
BRD-K45158365-001-02-3
BRD-K45158365-001-05-6
BSPBio_003501
C24H29N5O3
CCG-101028
CCG-221275
CGP 48933
CGP-48933
CHEBI:9927
CHEMBL1069
CPD000466318
CS-1967
D00400
DB00177
Diovan
Diovan (TN)
DS-1248
EC 604-045-2
Exforge
EZR-104
FT-0631156
GP8514
GTPL3937
GTPL593
HMS1922L21
HMS2051L12
HMS2093K22
HMS2232F05
HMS3651E04
HMS3715P12
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'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-
L-Valsartan
LS-161334
MCULE-6728882368
MFCD00865840
Miten
MLS000759423
MLS001424088
MolPort-002-507-854
MolPort-003-666-608
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)-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
NSC-758927
NSC758927
Pharmakon1600-01505209
Prexxartan
Prexxartan (oral solution)
Provas
PubChem9865
RTR-031794
S-6418
s1894
SAM001246581
SBI-0206738.P001
SC-00971
SCHEMBL2542
SMR000466318
SPBio_001260
Spectrum_001796
SPECTRUM1505209
Spectrum2_001120
Spectrum3_001831
Spectrum4_000749
Spectrum5_001582
SR-05000001928
SR-05000001928-1
ST2408288
SW197658-2
Tareg
TL8000869
TR-031794
UNII-80M03YXJ7I
V-120
VA11929
VAL-489
Valpression
Vals
Valsarran
valsartan (Diovan)
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; Certified Reference Material
Valsartan, United States Pharmacopeia (USP) Reference Standard
Valsartan,(S)
Valtan
Valzaar
Varexan
ZINC3875259

Paragraph IV (Patent) Challenges for VALSARTAN

Tradename	Dosage	Ingredient	NDA	Submissiondate
DIOVAN	TABLET;ORAL	valsartan	021283	2004-12-28

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
Amneal Pharms	VALSARTAN	valsartan	TABLET;ORAL	204011-004	Jan 11, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan	VALSARTAN	valsartan	TABLET;ORAL	090866-001	Jan 5, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Ivax Pharms	VALSARTAN	valsartan	TABLET;ORAL	077530-002	Jan 4, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Torrent	VALSARTAN	valsartan	TABLET;ORAL	202728-004	Jan 5, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>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	021283-003	Jul 18, 2001	Start Trial	Start Trial
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	Start Trial	Start Trial
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996	Start Trial	Start Trial
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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