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Amlodipine besylate - Generic Drug Details

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Amlodipine besylate is the generic ingredient in fifteen 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, Roxane, 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, Daiichi Sankyo, Torrent Pharms Ltd, Lupin Ltd, Symplmed Pharms Llc, Boehringer Ingelheim, Par Pharm Inc, Alembic Pharms Ltd, Novel Labs Inc, and Teva Pharms Usa, and is included in seventy-six 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-eight drug master file entries for amlodipine besylate. Sixty-nine suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Tradenames:15
Patents:11
Applicants:54
NDAs:76
Drug Master File Entries: see list48
Suppliers / Packaging: see list69
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

Clinical Trials for: amlodipine besylate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077671-001Jul 19, 2007RXNo
Gedeon Richter Usa
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077333-002Jul 17, 2007DISCNNo
Lupin
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090245-004Mar 30, 2015RXNo
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 19924,572,909*PED<disabled>
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 19924,879,303*PED<disabled>
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 19924,572,909*PED<disabled>
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)03043635<disabled in preview>
Argentina037565<disabled in preview>
European Patent Office1448197<disabled in preview>
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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
12/018Ireland<disabled>PRODUCT 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
00499Netherlands<disabled>PRODUCT 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
C/GB11/010United Kingdom<disabled>PRODUCT 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
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