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Last Updated: November 29, 2024

AMLODIPINE BESYLATE Drug Patent Profile

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Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?

Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in sixty-nine NDAs.

The generic ingredient in AMLODIPINE BESYLATE 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.

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Summary for AMLODIPINE BESYLATE

US Patents:	0
Applicants:	52
NDAs:	69
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	58
Patent Applications:	5,013
Drug Prices:	Drug price information for AMLODIPINE BESYLATE
Drug Sales Revenues:	Drug sales revenues for AMLODIPINE BESYLATE
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE?	AMLODIPINE BESYLATE excipients list
DailyMed Link:	AMLODIPINE BESYLATE at DailyMed

Drug patent expirations by year for AMLODIPINE BESYLATE

Drug Prices for AMLODIPINE BESYLATE

Recent Clinical Trials for AMLODIPINE BESYLATE

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4

See all AMLODIPINE BESYLATE clinical trials

Pharmacology for AMLODIPINE BESYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE

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 AMLODIPINE BESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puracap Pharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078131-001	Sep 4, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090011-003	Mar 28, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076846-003	Jun 28, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	206180-003	Dec 19, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AMLODIPINE BESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007	⤷ Sign Up	⤷ Sign Up
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007	⤷ Sign Up	⤷ Sign Up
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-002	Sep 27, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AMLODIPINE BESYLATE

See the table below for patents covering AMLODIPINE BESYLATE around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2002343257		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03043635		⤷ Sign Up
European Patent Office	1448197		⤷ Sign Up
Argentina	037565	FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AMLODIPINE BESYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland	⤷ Sign Up	PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1915993	300625	Netherlands	⤷ Sign Up	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	C300486	Netherlands	⤷ Sign Up	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
0443983	C00443983/03	Switzerland	⤷ Sign Up	PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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