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Last Updated: April 16, 2024

CADUET Drug Patent Profile


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Which patents cover Caduet, and what generic alternatives are available?

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 ⤷  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
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-005 Jan 30, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-010 Jul 29, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-011 Jul 29, 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

International Patents for CADUET

See the table below for patents covering CADUET around the world.

Country Patent Number Title Estimated Expiration
United Kingdom 8608335 ⤷  Try a Trial
Australia 6484296 ⤷  Try a Trial
China 101062035 ⤷  Try a Trial
New Zealand 203521 DIHYDROPYRIDINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Poland 141830 ⤷  Try a Trial
China 1190955 ⤷  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
1003503 91253 Luxembourg ⤷  Try a Trial 91253, EXPIRES: 20200707
0503785 C300486 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1507558 12C0033 France ⤷  Try a Trial 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: CH - 6167801 20110705
1507558 2012/018 Ireland ⤷  Try a Trial PRODUCT 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
0247633 SPC/GB97/011 United Kingdom ⤷  Try a Trial SPC/GB97/011: 20070529, EXPIRES: 20111106
0247633 97C0118 France ⤷  Try a Trial PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.