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CADUET Drug Profile

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Caduet is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. 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-eight drug master file entries for this compound. Four 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 list2
Formulation / Manufacturing:see details

Clinical Trials for: CADUET

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;ORAL021540-009Jul 29, 2004RXNo6,455,574<disabled> <disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-006Jan 30, 2004RXNo5,969,156*PED<disabled>Y<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 2004RXNo6,455,574<disabled> <disabled>
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Expired Patents for Tradename: CADUET

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-009Jul 29, 20044,681,893*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 20046,126,971*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 20046,126,971*PED<disabled>
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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
Israel128865<disabled in preview>
Canada2220018<disabled in preview>
Japan2004210797<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: CADUET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/058Ireland<disabled>PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF, AND AMLODIPINE, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/11/686/001-EU/1/11/686/056 20110414
1003503/01Switzerland<disabled>PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
C0033France<disabled>PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
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