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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, 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, Par Pharm Inc, Daiichi Sankyo, Torrent Pharms Ltd, Teva Pharms Usa, Lupin Ltd, Ajanta Pharma Ltd, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, and Novel Labs Inc, and is included in eighty-two 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-seven 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:55
NDAs:82
Drug Master File Entries: see list49
Suppliers / Packaging: see list77
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
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-007Apr 11, 2006RXNo6,162,802► subscribeYY ► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 2009RXNo8,475,839*PED► subscribeY► subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-002Jan 21, 2015RXNo7,846,961► subscribeYY ► 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;ORAL019787-002Jul 31, 19924,879,303*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
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
315Luxembourg► subscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
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