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Amlodipine besylate; atorvastatin calcium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amlodipine besylate; atorvastatin calcium?

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 three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; atorvastatin calcium 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:3
Applicants:3
NDAs:3
Drug Master File Entries: see list49
Suppliers / Packagers: see list6
Clinical Trials: see list1,084
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; atorvastatin calcium at DailyMed

Pharmacology for Ingredient: amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-004Jan 30, 2004RXYesNo5,969,156*PED► SubscribeY► Subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-011Nov 29, 2013RXNoNo► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 2004RXYesNo6,455,574► Subscribe ► Subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-005Nov 29, 2013RXNoNo► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-003Jan 30, 2004RXYesNo6,455,574► 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;ORAL021540-005Jan 30, 20045,273,995*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 20045,273,995*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 2004RE40667*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 20046,126,971*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 20044,572,909*PED► Subscribe
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International Patent Family for Ingredient: amlodipine besylate; atorvastatin calcium

Country Document Number Estimated Expiration
China1190955► Subscribe
Czech Republic294740► Subscribe
TunisiaSN98156► Subscribe
Austria332689► Subscribe
Japan2004210797► 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
/2006Austria► SubscribePRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707
0625Netherlands► SubscribePRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
253Luxembourg► Subscribe91253, EXPIRES: 20200707
00625Netherlands► SubscribePRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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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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