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AMLODIPINE BESYLATE Drug Profile

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Which patents cover Amlodipine Besylate, and what substitute generic drugs are available?

Amlodipine Besylate is a drug marketed by Sovereign Pharms, Wockhardt, Vintage, Vivimed Labs, Mylan, Apotex, Aurobindo Pharma, Polygen Pharms, Mylan Pharms Inc, Alkem, Synthon Pharms, Zydus Pharms Usa, Puracap Pharm, Sun Pharm Inds Inc, Gedeon Richter Usa, Lupin, Unichem Labs Ltd, Teva, China Resources, Epic Pharma Llc, Accord Hlthcare, Orchid Hlthcare, Invagen Pharms, Sandoz, Upsher Smith, Genpharm, West-ward Pharms Int, Hikma Pharms, Watson Labs, Cipla Ltd, Torrent Pharms, Sun Pharm Inds Ltd, Amneal Pharms Ny, Macleods Pharms Ltd, Sun Pharm Inds, Dr Reddys Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Watson Labs Inc, Lupin Pharms, Teva Pharms, Par Pharm, Par Pharm Inc, Alembic Pharms Ltd, Novel Labs Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd. and is included in sixty-four NDAs. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for Tradename: AMLODIPINE BESYLATE

Patents:1
Applicants:49
NDAs:64
Suppliers / Packagers: see list71
Bulk Api Vendors: see list85
Clinical Trials: see list143
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AMLODIPINE BESYLATE at DailyMed

Pharmacology for Tradename: AMLODIPINE BESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL076859-003Sep 10, 2007DISCNNoNo► Subscribe► Subscribe
Lupin Ltd
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200797-001Jun 3, 2015RXNoNo► Subscribe► Subscribe
Amneal Pharms Ny
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL078477-002Jan 16, 2008RXNoNo► Subscribe► Subscribe
Sun Pharm Inds Inc
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL078231-002Nov 30, 2007RXNoNo► Subscribe► Subscribe
Synthon Pharms
AMLODIPINE BESYLATE
amlodipine besylate
TABLET, ORALLY DISINTEGRATING;ORAL022026-002Sep 27, 2007DISCNNoNo6,828,339► SubscribeY ► Subscribe
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Premature patent expiration for: AMLODIPINE BESYLATE

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
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AMLODIPINE BESYLATE
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International Patent Family for Tradename: AMLODIPINE BESYLATE

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)03043635► Subscribe
European Patent Office1448197► Subscribe
Argentina037565► Subscribe
Australia2002343257► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMLODIPINE BESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
C0048France► SubscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
C0033France► SubscribePRODUCT 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: 6167801 20110705
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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