NORVASC Drug Patent Profile

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

Norvasc is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in NORVASC is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norvasc

A generic version of NORVASC was approved as amlodipine besylate by APOTEX on May 23^rd, 2007.

Summary for NORVASC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	57
Patent Applications:	4,669
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NORVASC
What excipients (inactive ingredients) are in NORVASC?	NORVASC excipients list
DailyMed Link:	NORVASC at DailyMed

See drug prices for NORVASC

See drug sales revenues for NORVASC

Recent Clinical Trials for NORVASC

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	Phase 2

See all NORVASC clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NORVASC

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

US Patents and Regulatory Information for NORVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	AB	RX	Yes	No
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	AB	RX	Yes	No
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	AB	RX	Yes	Yes

Expired US Patents for NORVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992

International Patents for NORVASC

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

Country	Patent Number	Title	Estimated Expiration
Kenya	3778	DIHYDROPYRIDINE ANTI-ISCHAEMIC AND ANTIHYPERTENSIVE AGENTS,PROCESSES FOR THEIR PRODUCTION,AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Sweden	8701348
Egypt	16987	PROCESS FOR PREPARING NOVEL 1,4-DIHYDROPYRIDINE DERIVATIVES
Ecuador	SP941129	UN PROCEDIMIENTO PARA LA PREPARACION DE LA SAL DE BESILATO DE AMLODIPINA
Norway	864435
Germany	3761485

Supplementary Protection Certificates for NORVASC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	300625	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	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0089167	SPC/GB93/046	United Kingdom		SPC/GB93/046: 20040307
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
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
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