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Last Updated: May 28, 2020

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CADUET Drug Profile


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When do Caduet patents expire, and when can generic versions of Caduet launch?

Caduet is a drug marketed by Pfizer 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Drug patent expirations by year for CADUET
Drug Prices for CADUET

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Recent Clinical Trials for CADUET

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SponsorPhase
Hyo-Soo KimPhase 4
Kosin University Gospel HospitalPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all CADUET clinical trials

Recent Litigation for CADUET

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED2015-01-14
Edwards Lifesciences AG v. CoreValve, Inc.2014-04-14
Pfizer Inc. v. Dr. Reddy's Laboratories Ltd.2012-04-13

See all CADUET litigation

Synonyms for CADUET
(RS)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
(s)-(-)-amlodipine
2-(2-aminoethoxy)methyl-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic acid O3-ethyl ester O5-methyl ester
2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate
2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methylester
2-[2-Aminoethoxymethyl]-3-ethoxycarbonyl-4-(2-chlorophenyl)-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-[2-aminoethoxymethyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-Ethyl 5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate (C6H5SO3H)
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzene sulfonate
3-ethyl 5-methyl 2-{[(2-aminoethyl)oxy]methyl}-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-Ethyl 5-methylester, (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-Ethyl-5-methyl ( -)-2-((2-aminoethoxy)methyl)-4-(2-chlorphenyl)-1,4-dihydro-6-methyl-3,5-pyridindicarboxylat
3-Ethyl-5-methyl ( -)-2-((2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-Ethyl-5-methyl (.+/-.)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-Ethyl-5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(2-chlorphenyl)-1,4-dihydro-6-methyl-3,5-pyridindicarboxylat
3-Ethyl-5-methyl (+-)-2-((2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-Ethyl-5-methyl (+-)-2-(2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-O-ethyl 5-O-methyl 4-(2-chlorophenyl)-1-deuterio-2-[2-(dideuterioamino)ethoxymethyl]-6-methyl-4H-pyridine-3,5-dicarboxylate
3,5-Pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester
3,5-pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, benzene sulfonate
50A429
88150-42-9
A800681
AB0008128
AB01209618-01
AB01274726_03
AB01274726_04
AB01274726_05
AB01274726-01
AB01274726-02
AB2000364
ABP000734
AC-4535
AK163198
AKOS015843475
ALBB-027270
Amlocard
amlodipine
amlodipine (NORVASC)
Amlodipine (USAN/INN)
Amlodipine [INN:BAN]
AMLODIPINE BASE
Amlodipine Free Base
Amlodipine(Norvasc)
Amlodipine/
Amlodipino
Amlodipino [Spanish]
Amlodipinum
Amlodipinum [Latin]
Amlodis
Amlor
API0005963
AS-13747
AX8042079
BBL023710
BCP02420
BCP9000295
BCPP000403
BDBM50088383
BG0034
BIDD:GT0810
BRD-A22032524-074-02-4
BRD-A22032524-074-03-2
BRD-A22032524-074-04-0
BSPBio_002727
C06825
C20H25ClN2O5
CA0134
CCG-101157
CCG-220414
CHEBI:2668
CHEMBL1491
CHEMBL3211346
CHEMBL3304444
CKD-330 COMPONENT AMLODIPINE
Copalia (amlodipine + valsartan)
Coroval
CPD000469198
CPD004727074
CS-2357
D07450
DB00381
DTXSID7022596
EC 425-820-1
FT-0602653
GTPL6981
HGP-0904
HGP0904
HMS2052N03
HMS2089H07
HMS2231K08
HMS3370G17
HMS3394N03
HMS3651I04
HMS3713C10
HSDB 7079
HTIQEAQVCYTUBX-UHFFFAOYSA-N
HY-B0317
Istin
Istin;Norvasc;Caduet;Norvasc
J10237
K577
Katerzia® (amlodipine oral suspension, 1 mg/mL)
KBio3_001947
KBioGR_001643
KS-00000L67
Lipinox
LS-131183
MCULE-8264151664
MFCD00864687
MLS001401409
NC00407
NCGC00165957-01
NCGC00165957-02
NCGC00165957-03
NCGC00165957-04
NCGC00165957-05
NCGC00165957-07
Norvasc
Norvasc (TN)
O3-ethyl O5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
O3-ethyl O5-methyl 2-(2-azanylethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Q411347
R3932
Racemic Amlodipine
s1905
SAM001246705
SC-15164
SC-16184
SC-16480
SCHEMBL26478
SMR000469198
SPBio_000351
Spectrum2_000486
Spectrum3_001004
Spectrum4_001132
Spectrum5_001550
SR-05000001461
SR-05000001461-3
SR-05000001461-4
SR-05000001461-5
ST24045949
STL356053
SW220228-1
UK-48340
UK-4834011
W-3152
ZX-AN025779
Paragraph IV (Patent) Challenges for CADUET
Tradename Dosage Ingredient NDA Submissiondate
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-09-17
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-04-07
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 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
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-009 Jul 29, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 Jan 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-005 Jan 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-010 Jul 29, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-011 Jul 29, 2004 AB RX Yes No   Start Trial   Start Trial   Start 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

Supplementary Protection Certificates for CADUET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 C300625 Netherlands   Start Trial 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
0443983 2007C/043 Belgium   Start Trial PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0247633 C970034 Netherlands   Start Trial PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
1507558 2012/018 Ireland   Start 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
1507558 C300528 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0089167 SPC/GB93/046 United Kingdom   Start Trial SPC/GB93/046: 20040307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
AstraZeneca
McKinsey
Boehringer Ingelheim
Express Scripts

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.