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Generated: September 20, 2017

DrugPatentWatch Database Preview

AMLODIPINE BESYLATE Drug Profile

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

Amlodipine Besylate is a drug marketed by Sovereign Pharms, Wockhardt, Vintage, Vivimed Global, Mylan Pharms Inc, Apotex, Aurobindo Pharma, Polygen Pharms, 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 Labs, 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, Mylan, 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 fifty drug master file entries for this compound. Eight suppliers are listed for this compound. There are five tentative approvals 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 list70
Bulk Api Vendors: see list85
Clinical Trials: see list432
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 TE 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► Subscribe
Lupin Ltd
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200797-001Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Ny
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL078477-002Jan 16, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL078231-002Nov 30, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Synthon Pharms
AMLODIPINE BESYLATE
amlodipine besylate
TABLET, ORALLY DISINTEGRATING;ORAL022026-002Sep 27, 2007DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Teva Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL077179-004May 18, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-004Feb 5, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Pharms
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077771-002Apr 12, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-001Nov 29, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL091431-006Dec 30, 2013ABRXNoNo► Subscribe► Subscribe► 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
Australia2002343257► Subscribe
World Intellectual Property Organization (WIPO)03043635► Subscribe
Argentina037565► Subscribe
European Patent Office1448197► 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
0625Netherlands► SubscribePRODUCT 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
00499Netherlands► SubscribePRODUCT 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
00625Netherlands► SubscribePRODUCT 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
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
12/018Ireland► SubscribePRODUCT 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
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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
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Serving 500+ biopharmaceutical companies globally:

Covington
Mallinckrodt
AstraZeneca
Novartis
Cerilliant
Moodys
Healthtrust
QuintilesIMS
Cipla
Farmers Insurance

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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