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Amlodipine besylate; atorvastatin calcium - Generic Drug Details

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Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Pfizer, Mylan Pharms Inc, and Dr Reddys Labs Ltd, and is included in three NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-four patent family members in fifty-two countries.

There are forty-nine drug master file entries for amlodipine besylate; atorvastatin calcium. Six suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; atorvastatin calcium

Tradenames:2
Patents:2
Applicants:3
NDAs:3
Drug Master File Entries: see list49
Suppliers / Packagers: see list6
Clinical Trials: see list1,084
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-008Jan 30, 2004RXYes5,969,156*PED► subscribeY► subscribe
Dr Reddys Labs Ltd
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL203874-002Mar 7, 2014RXNo► subscribe► subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-004Nov 29, 2013RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-009Jul 29, 20045,686,104*PED► subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-009Jul 29, 20045,273,995*PED► subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 20044,879,303*PED► subscribe
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International Patent Family for Ingredient: amlodipine besylate; atorvastatin calcium

Country Document Number Estimated Expiration
Slovakia6298► subscribe
Japan4790194► subscribe
Spain2233526► 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; ATORVASTATIN CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048France► subscribePRODUCT 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
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
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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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