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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-eight drug master file entries for amlodipine besylate; atorvastatin calcium. Four 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 list48
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; atorvastatin calcium

Clinical Trials for: 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;ORAL021540-004Jan 30, 2004RXNo5,969,156*PED<disabled>Y<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 2004RXNo6,455,574<disabled> <disabled>
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-002Nov 29, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; atorvastatin calcium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-002Jan 30, 2004RE40667*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 20045,686,104*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 20046,126,971*PED<disabled>
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International Patent Family for Ingredient: amlodipine besylate; atorvastatin calcium

Country Document Number Estimated Expiration
Canada2301732<disabled in preview>
Austria277615<disabled in preview>
Germany69634054<disabled in preview>
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Supplementary Protection Certificates for Tradename: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1003503/01Switzerland<disabled>PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
/2006Austria<disabled>PRODUCT 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
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
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