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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 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, 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, Ajanta Pharma Ltd, Jubilant Generics, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, and Novel Labs Inc, and is included in eighty-six NDAs. There are twelve 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 forty-nine drug master file entries for amlodipine besylate. Seventy-five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Tradenames:17
Patents:12
Applicants:56
NDAs:86
Drug Master File Entries: see list49
Suppliers / Packagers: see list75
Bulk Api Vendors: see list85
Clinical Trials: see list429
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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Invagen Pharms
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL206367-001Dec 10, 2015ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL206512-001Apr 22, 2016ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL206512-004Apr 22, 2016ABRXNoNo► Subscribe► Subscribe
Torrent Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL202933-002Nov 25, 2016ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200797-005Jun 3, 2015ABRXNoNo► 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;ORAL019787-002Jul 31, 19924,879,303*PED► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,879,303*PED► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 19924,572,909*PED► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 19924,572,909*PED► Subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,572,909*PED► Subscribe
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Estimated Expiration
Argentina037565► Subscribe
World Intellectual Property Organization (WIPO)03043635► Subscribe
European Patent Office1448197► 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
00375Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Medtronic
Teva
Baxter
Julphar
Colorcon
QuintilesIMS
Express Scripts
Cerilliant
Moodys

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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