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Amlodipine besylate - Generic Drug Details

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

Amlodipine besylate is the generic ingredient in eighteen branded drugs marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Upsher Smith Labs, Watson Labs, Wockhardt, Yaopharma Co Ltd, Yiling, Zydus Pharms Usa, Upjohn, Dr Reddys, Zydus Pharms, Pharmacia, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Coeptis, Par Pharm Inc, Teva Pharms Usa, Torrent, Daiichi Sankyo, Lupin Ltd, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Sciegen Pharms Inc, Adhera, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety-nine NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate has five patent family members in five countries.

There are fifty drug master file entries for amlodipine besylate. Fifty-one suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for amlodipine besylate

International Patents:	5
US Patents:	8
Tradenames:	18
Applicants:	64
NDAs:	99
Drug Master File Entries:	50
Suppliers / Packagers:	51
Bulk Api Vendors:	100
Clinical Trials:	53
Patent Applications:	4,280
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for amlodipine besylate
Drug Sales Revenues:	Drug sales revenues for amlodipine besylate
DailyMed Link:	amlodipine besylate at DailyMed

See drug prices for amlodipine besylate

See drug sales revenues for amlodipine besylate

Recent Clinical Trials for amlodipine besylate

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

Sponsor	Phase
University of Pennsylvania	Phase 4
Shanghai Jiao Tong University School of Medicine	Phase 4
Conjupro Biotherapeutics	Phase 1

See all amlodipine besylate clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 10MG BASE	TABLET;ORAL
		EQ 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for amlodipine besylate

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NORVASC	TABLET;ORAL	amlodipine besylate	019787

US Patents and Regulatory Information for amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077183-002	Apr 15, 2010	AB	RX	No	No
Jubilant Generics	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207450-001	May 15, 2017	AB	RX	No	No
Lupin	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078043-002	Jul 12, 2007	AB	RX	No	No

Expired US Patents for amlodipine besylate

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

International Patents for amlodipine besylate

Country	Patent Number	Estimated Expiration
Australia	2002343257
World Intellectual Property Organization (WIPO)	03043635
Norway	20042539

Supplementary Protection Certificates for amlodipine besylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
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