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EXFORGE Drug Profile

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Which patents cover Exforge, and what generic alternatives are available?

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. Four 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

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.

Indicators of Generic Entry

Summary for EXFORGE

US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	124
Clinical Trials:	14
Patent Applications:	5,207
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

See drug prices for EXFORGE

See drug sales revenues 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
Dong-A Pharmaceutical Co., Ltd.	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

ACT02671

ACWBQPMHZXGDFX-QFIPXVFZSA-N

AK-58790

AKOS015914315

AKOS015994698

AM90287

ANW-49040

AX8018200

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

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-Valine,N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-3-yl]methyl]- (9CI)

L-Valsartan

LS-161334

MCULE-6728882368

MFCD00865840

Miten

MLS000759423

MLS001424088

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-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

Q155472

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

TR-031794

UNII-80M03YXJ7I

V-120

VA11929

VAL-489

Valpression

Vals

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

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

Expired US Patents for EXFORGE

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

International Patents for EXFORGE

Country	Patent Number	Estimated Expiration
Russian Federation	2203054
South Korea	101161283
Malaysia	146868
Luxembourg	90100
Taiwan	473394
Netherlands	970001

Supplementary Protection Certificates for EXFORGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	SPC/GB97/009	United Kingdom		PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0443983	91347	Luxembourg		91347, EXPIRES: 20160212
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK