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Last Updated: May 28, 2022

CADUET Drug Patent Profile


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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. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 Jan 30, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021540-004 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CADUET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 SPC/GB11/010 United Kingdom See Plans and Pricing 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
1915993 C300625 Netherlands See Plans and Pricing PRODUCT 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
0247633 97C0103 Belgium See Plans and Pricing PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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