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EXFORGE Drug Profile

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. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for EXFORGE

US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	123
Clinical Trials:	14
Patent Applications:	4,982
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

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	See Pricing	See Pricing	Y			See Pricing
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	See Pricing	See Pricing	Y			See Pricing
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	AB	RX	Yes	Yes	See Pricing	See Pricing	Y			See Pricing
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No	See Pricing	See Pricing			Y	See Pricing
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	See Pricing	See Pricing			Y	See Pricing
>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	021990-004	Jun 20, 2007	See Pricing	See Pricing
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	See Pricing	See Pricing
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	See Pricing	See Pricing
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	See Pricing	See Pricing
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	See Pricing	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for EXFORGE

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	10 mg/12.5 mg/160 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	5 mg/320 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	10 mg/320 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	See Pricing
➤ Subscribe	Tablets	10 mg/160 mg	➤ Subscribe	See Pricing