CADUET Drug Patent Profile
✉ Email this page to a colleague
When do Caduet patents expire, and when can generic versions of Caduet launch?
Caduet is a drug marketed by Pharmacia and is included in one NDA.
The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Caduet
A generic version of CADUET was approved as amlodipine besylate; atorvastatin calcium by MYLAN on November 29th, 2013.
Summary for CADUET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 13 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CADUET |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CADUET |
What excipients (inactive ingredients) are in CADUET? | CADUET excipients list |
DailyMed Link: | CADUET at DailyMed |


Paragraph IV (Patent) Challenges for CADUET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 2.5 mg/40 mg | 021540 | 1 | 2009-09-17 |
CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 5 mg/80 mg | 021540 | 1 | 2009-04-07 |
CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg | 021540 | 1 | 2006-12-29 |
US Patents and Regulatory Information for CADUET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-009 | Jul 29, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-004 | Jan 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-001 | Jan 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for CADUET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-009 | Jul 29, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-003 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-008 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CADUET
See the table below for patents covering CADUET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | H0358967 | (R-(R.,R.))-2-(4-FLUOROPHENYL)-BETA,DELTA- DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL -4-((PHENYLAMINO)CARBONYL)-1H- PYRROLE-1-HEPTANIC ACID, LACTONE THEREOF AND SALT THEREOF | ⤷ Try a Trial |
New Zealand | 312907 | Crystalline [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl | ⤷ Try a Trial |
Ecuador | SP941129 | UN PROCEDIMIENTO PARA LA PREPARACION DE LA SAL DE BESILATO DE AMLODIPINA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CADUET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | SPC/GB11/010 | United Kingdom | ⤷ Try a Trial | 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 |
0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
1003503 | SZ 30/2006 | Austria | ⤷ Try a Trial | PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SĂ„UREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |