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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
Formulation / Manufacturing:see details

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
Teva Pharms
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200435-004Sep 25, 2012RXNo<disabled><disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-003Apr 30, 2009RXNo6,294,197*PED<disabled>Y<disabled>
Upsher Smith
AMLODIPINE BESYLATE
amlodipine besylate
TABLET;ORAL077759-001Jul 9, 2007RXNo<disabled><disabled>
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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;ORAL019787-003Jul 31, 19924,572,909*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>
Australia2002343257<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
00478Netherlands<disabled>PRODUCT 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
C0048France<disabled>PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
00528Netherlands<disabled>PRODUCT 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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