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Serving 500+ biopharmaceutical companies globally:

Covington
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Chinese Patent Office
Cantor Fitzgerald
Chubb
Moodys
McKesson
Cerilliant
Merck
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Generated: August 17, 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 Labs, 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, Jubilant Generics, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, and Novel Labs Inc, and is included in eighty-seven 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.

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

Summary for Generic Name: amlodipine besylate

Tradenames:17
Patents:11
Applicants:57
NDAs:87
Drug Master File Entries: see list50
Suppliers / Packagers: see list74
Bulk Api Vendors: see list85
Clinical Trials: see list432
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
► Subscribe► Subscribe10MG; 20MGCAPSULE; ORAL
► Subscribe► Subscribe5MG; 20MGCAPSULE; ORAL
► Subscribe► Subscribe5MG; 10MGCAPSULE; ORAL

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;ORAL019787-001Jul 31, 1992► Subscribe► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 1992► Subscribe► Subscribe
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Estimated Expiration
Argentina037565► Subscribe
European Patent Office1448197► Subscribe
World Intellectual Property Organization (WIPO)03043635► 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
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
00486Netherlands► SubscribePRODUCT 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
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00528Netherlands► SubscribePRODUCT 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
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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
US Department of Justice
McKinsey
Teva
Cipla
Cantor Fitzgerald
Citi
Fish and Richardson
Queensland Health

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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