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Serving leading biopharmaceutical companies globally:

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Queensland Health
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Generated: October 20, 2017

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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 amlodipine besylate freedom to operate?

Amlodipine besylate
is the generic ingredient in seventeen branded drugs 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, Pfizer, Dr Reddys Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Mylan, Dr Reddys Labs Inc, Watson Labs Inc, Novartis, Lupin Pharms, Teva Pharms, Par Pharm, Par Pharm Inc, Daiichi Sankyo, Torrent Pharms Ltd, Teva Pharms Usa, Lupin Ltd, Glenmark Pharms Ltd, Ajanta Pharma Ltd, Alkem Labs Ltd, Jubilant Generics, Zydus Pharms Usa Inc, Alembic Pharms Ltd, Symplmed Pharms Llc, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate has four patent family members in four countries and sixteen supplementary protection certificates in eight countries.

There are fifty drug master file entries for amlodipine besylate. Seventy-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

US Patents:11
Tradenames:17
Applicants:59
NDAs:90
Drug Master File Entries: see list50
Suppliers / Packagers: see list77
Bulk Api Vendors: see list97
Clinical Trials: see list434
Patent Applications: see list3,722
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amlodipine besylate at DailyMed

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Strength Dosage Form
u► Subscribe10MG; 20MGCAPSULE; ORAL
u► Subscribe5MG; 20MGCAPSULE; ORAL
u► Subscribe5MG; 10MGCAPSULE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207771-001Sep 22, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-011Jul 29, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL076418-003Oct 3, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Synthon Pharms
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077080-001Jun 27, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090483-001Mar 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL201087-001Jun 1, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL077183-003Apr 15, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-001Feb 5, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL077890-001Oct 14, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL076692-001Jul 20, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 1992► Subscribe► Subscribe
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Estimated Expiration
European Patent Office1448197► Subscribe
World Intellectual Property Organization (WIPO)03043635► 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
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
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
2011 00026Denmark► SubscribePRODUCT 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
315Luxembourg► SubscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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
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
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
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 leading biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
Daiichi Sankyo
Fuji
Federal Trade Commission
Teva
UBS
Covington
Julphar
Harvard Business School

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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