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CADUET Drug Profile

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Which patents cover Caduet, and what substitute generic drugs are available?

Caduet is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Summary for Tradename: CADUET

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list74
Clinical Trials: see list3
Patent Applications: see list7,149
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:CADUET at DailyMed
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;ORAL021540-009Jul 29, 2004RXYesNo6,455,574► Subscribe ► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-006Jan 30, 2004RXYesNo5,969,156*PED► SubscribeY► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 2004RXYesNo6,455,574► Subscribe ► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 2004RXYesNo5,969,156*PED► SubscribeY► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-003Jan 30, 2004RXYesNo5,969,156*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: CADUET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 20044,879,303*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-009Jul 29, 20044,681,893*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-011Jul 29, 20045,686,104*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 20046,126,971*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 20046,126,971*PED► Subscribe
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Paragraph IV activity for: CADUET

Drugname Dosage Strength RLD Submissiondate
amlodipine besylate and atorvastatin calciumTablets2.5 mg/40 mgCaduet9/17/2009
amlodipine besylate and atorvastatin calciumTablets5 mg/80 mgCaduet4/7/2009
amlodipine besylate and atorvastatin calciumTablets5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mgCaduet12/29/2006

International Patent Family for Tradename: CADUET

Country Document Number Estimated Expiration
Israel128862► Subscribe
Turkey200000561► Subscribe
Germany69616808► Subscribe
Germany69835245► Subscribe
Japan4790194► 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: CADUET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/018Ireland► SubscribePRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
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
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
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
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