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CADUET Drug Profile
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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 list | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: : | see details |
Pharmacology for Tradename: CADUET
| Ingredient-type | Dihydropyridines |
| Drug Class | Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Calcium Channel Antagonists Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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;ORAL | 021540-009 | Jul 29, 2004 | RX | No | 6,455,574 | Aug 11, 2018 | ||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-006 | Jan 30, 2004 | RX | No | 5,969,156*PED | Jan 8, 2017 | Y | |||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-001 | Jan 30, 2004 | RX | No | 6,455,574 | Aug 11, 2018 | ||||||||||||||||||||
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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;ORAL | 021540-009 | Jul 29, 2004 | 4,572,909*PED | <disabled> | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-005 | Jan 30, 2004 | 4,879,303*PED | <disabled> | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-008 | Jan 30, 2004 | RE40667*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: CADUET
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| amlodipine besylate and atorvastatin calcium | Tablets | 2.5 mg/40 mg | Caduet | 9/17/2009 |
| amlodipine besylate and atorvastatin calcium | Tablets | 5 mg/80 mg | Caduet | 4/7/2009 |
| amlodipine besylate and atorvastatin calcium | Tablets | 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg | Caduet | 12/29/2006 |
International Patent Family for Tradename: CADUET
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 8554898 | <disabled in preview> | |||||||||||||||||||||||||||
| Spain | 2233526 | <disabled in preview> | |||||||||||||||||||||||||||
| Panama | 8457101 | <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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2006 | Austria | <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 | ||||||||||||||||||||||||||
| C0048 | France | <disabled> | PRODUCT 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 | ||||||||||||||||||||||||||
| C/GB11/010 | United Kingdom | <disabled> | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK | ||||||||||||||||||||||||||
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