AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details

What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of patent protection?

Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Lupin Ltd, Strides Pharma, Teva Pharms, Torrent, and Novartis, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
DailyMed Link:	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN at DailyMed

Pharmacology for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	10 mg/12.5 mg/ 160 mg	022314	1	2009-10-22
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	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 mg	022314	1	2009-09-14

US Patents and Regulatory Information for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	201087-003	Jun 1, 2015	AB	RX	No	No
Aurobindo Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	206180-004	Dec 19, 2017	AB	RX	No	No
Strides Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	201087-002	Jun 1, 2015	AB	RX	No	No
Aurobindo Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	206180-001	Dec 19, 2017	AB	RX	No	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes
Teva Pharms	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	200435-002	Sep 25, 2012		DISCN	No	No

Expired US Patents for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009