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CADUET Drug Profile

When do Caduet patents expire, and what generic alternatives are available?

Caduet is a drug marketed by Pfizer and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has sixty-six patent family members in forty-six countries.

The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty 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 CADUET

International Patents:	66
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	91
Clinical Trials:	12
Patent Applications:	4,611
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CADUET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CADUET
DailyMed Link:	CADUET at DailyMed

Drug patent expirations by year for CADUET

Pharmacology for CADUET

Drug Class	Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor
Mechanism of Action	Calcium Channel Antagonists Hydroxymethylglutaryl-CoA Reductase Inhibitors

Synonyms for CADUET

(+-)-AMLODIPINE
(RS)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
(S)-Amlodipine-d4
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)
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-aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarboxylat
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-(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-ethyl-5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-ethyl5-methylester
3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-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
3,5-pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, benzene sulfonate
3,5-pyridinedicarboxylicacid,1,4-dihydro-2-((2-aminoethoxy)methyl)-4-(2-chlor
50A429
88150-42-9
88150-47-4 (maleate (1:1))
A800681
AB0008128
AB01209618-01
AB01274726_03
AB01274726_04
AB01274726_05
AB01274726-01
AB01274726-02
AB2000364
ABP000734
AC-4535
AC1L1D26
AC1Q32ZS
AK163198
AKOS015843475
ALBB-027270
Ambap88150-42-9
Amlocard
Amlodipin
amlodipine
Amlodipine (INN)
amlodipine (NORVASC)
Amlodipine (USAN/INN)
Amlodipine [INN:BAN]
AMLODIPINE BASE
Amlodipine besilate
Amlodipine Free Base
Amlodipine mesylate
Amlodipine/
Amlodipino
Amlodipino [Spanish]
Amlodipinum
Amlodipinum [Latin]
Amlodis
Amlopres
Amlor
Amvaz
AN-11880
AN-14382
API0005963
AS-13747
AX8042079
BBL023710
BC203909
BCP9000295
BCPP000403
BDBM50088383
BG0034
BIDD:GT0810
BRD-A22032524-074-02-4
BRD-A22032524-074-03-2
BSPBio_002727
C06825
C20H25ClN2O5
CA0134
CCG-101157
CCG-220414
CHEBI:2668
CHEMBL1491
CHEMBL3211346
CHEMBL3304444
Coroval
CPD000469198
CPD004727074
CS-2357
D07450
D08JIV
Dailyvasc (TN)
DB00381
DR002433
DTXSID7022596
EC 425-820-1
FT-0602653
GTPL6981
HE196050
HE402055
HMS2052N03
HMS2089H07
HMS2231K08
HMS3370G17
HMS3394N03
HMS3651I04
HSDB 7079
HTIQEAQVCYTUBX-UHFFFAOYSA-N
HY-B0317
I14-0798
Intervask
Istin
Istin (TN)
Istin;Norvasc;Caduet;Norvasc
J10237
K577
KBio3_001947
KBioGR_001643
KS-00000L67
Lipinox
LS-131183
MCULE-8264151664
methyl ethyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
MFCD00864687
MLS001401409
MolPort-001-792-963
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
Perivasc (TN)
R,S)-Amlodipine
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-05000001461-5
ST24045949
STL356053
UK-48,340
UK-4834011
W-3152
ZX-AN025779

US Patents and Regulatory Information for CADUET

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004	AB	RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-001	Jan 30, 2004	AB	RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-005	Jan 30, 2004	AB	RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	➤ Sign Up	➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-001	Jan 30, 2004	➤ Sign Up	➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	➤ Sign Up	➤ Sign Up
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-007	Jan 30, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for CADUET

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	2.5 mg/40 mg	➤ Subscribe	➤ Sign Up
➤ Subscribe	Tablets	5 mg/80 mg	➤ Subscribe	➤ Sign Up
➤ Subscribe	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	➤ Subscribe	➤ Sign Up

International Patents for CADUET

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Country	Document Number	Estimated Expiration
Poland	339092	➤ Sign Up
New Zealand	537880	➤ Sign Up
Eurasian Patent Organization	200000164	➤ Sign Up
Guatemala	199800127	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for CADUET

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0625	Netherlands	➤ Sign Up	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
/2006	Austria	➤ Sign Up	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
12/018	Ireland	➤ Sign Up	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
315	Luxembourg	➤ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for CADUET

Pharmacology for CADUET

Synonyms for CADUET

Paragraph IV (Patent) Challenges for CADUET

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