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Amlodipine besylate - Generic Drug Details

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Amlodipine besylate is the generic ingredient in seventeen branded drugs 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, Pfizer, Dr Reddys Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, 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, Torrent Pharms Llc, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, and Novel Labs Inc, and is included in eighty-four NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has four patent family members in four countries.

There are forty-nine drug master file entries for amlodipine besylate. Seventy-eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Tradenames:17
Patents:11
Applicants:56
NDAs:84
Drug Master File Entries: see list49
Suppliers / Packagers: see list78
Bulk Api Vendors: see list85
Clinical Trials: see list143
Patent Applications: see list2,198
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL2.5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL078224-001Feb 27, 2008RXNo► subscribe► subscribe
West-ward Pharms Int
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077262-002Jul 9, 2007RXNo► subscribe► subscribe
Dr Reddys Labs Inc
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL077183-003Apr 15, 2010RXNo► 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;ORAL019787-001Jul 31, 19924,572,909*PED► subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,572,909*PED► subscribe
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,879,303*PED► subscribe
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Estimated Expiration
Australia2002343257► subscribe
Argentina037565► subscribe
World Intellectual Property Organization (WIPO)03043635► 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
13/058Ireland► subscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF, AND AMLODIPINE, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/11/686/001-EU/1/11/686/056 20110414
07C/043Belgium► subscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
315Luxembourg► subscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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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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