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EXFORGE Drug Profile

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When do Exforge patents expire, and when can generic versions of Exforge launch?

Exforge is a drug marketed by Novartis and is included in two NDAs. There are three patents protecting this drug and six Paragraph IV challenges.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

US ANDA Litigation and Generic Entry Outlook for Exforge

Exforge was eligible for patent challenges on December 31, 1968.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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Summary for EXFORGE

US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	124
Clinical Trials:	14
Patent Applications:	5,209
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXFORGE
Drug Sales Revenues:	Drug sales revenues for EXFORGE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXFORGE
DailyMed Link:	EXFORGE at DailyMed

Drug patent expirations by year for EXFORGE

Recent Clinical Trials for EXFORGE

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1
Severance Hospital	Phase 1

See all EXFORGE clinical trials

Recent Litigation for EXFORGE

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 EXFORGE litigation

Pharmacology for EXFORGE

Drug Class	Dihydropyridine Calcium Channel Blocker Angiotensin 2 Receptor Blocker
Mechanism of Action	Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists

Synonyms for EXFORGE

(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
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
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 EXFORGE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EXFORGE	TABLET;ORAL	amlodipine besylate; valsartan	021990	2007-11-26
EXFORGE	TABLET;ORAL	amlodipine besylate; valsartan	021990	2007-11-09
EXFORGE	TABLET;ORAL	amlodipine besylate; valsartan	021990	2007-10-22
EXFORGE	TABLET;ORAL	amlodipine besylate; valsartan	021990	2007-10-01

US Patents and Regulatory Information for EXFORGE

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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
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	AB	RX	Yes	No	Start Trial	Start Trial	Y			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 EXFORGE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	Start Trial	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration