EXFORGE Drug Patent Profile

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

Exforge is a drug marketed by Novartis and is included in two NDAs.

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.

Summary for EXFORGE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	15
Drug Prices:	Drug price information for EXFORGE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXFORGE
What excipients (inactive ingredients) are in EXFORGE?	EXFORGE excipients list
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
International Bio service	Phase 1
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1

See all EXFORGE clinical trials

Pharmacology for EXFORGE

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Paragraph IV (Patent) Challenges for EXFORGE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/320 mg	021990	1	2007-11-26
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/320 mg	021990	1	2007-11-09
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/160 mg	021990	1	2007-10-22
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/160 mg	021990	1	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
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	AB	RX	Yes	Yes
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	AB	RX	Yes	Yes
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No

Expired US Patents for EXFORGE

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

International Patents for EXFORGE

See the table below for patents covering EXFORGE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101208430
Cyprus	2553	Solid oral dosage forms of valsartan
Portugal	1410797
South Korea	20090099020
European Patent Office	0443983	Composés acylés (Acyl compounds)
Spain	2084801
South Korea	0171409

Supplementary Protection Certificates for EXFORGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0443983	C980036	Netherlands		PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
0443983	97C0039	Belgium		PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
0443983	98C004	Belgium		PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925