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CADUET Drug Profile

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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. Five 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:	3
Bulk Api Vendors:	85
Clinical Trials:	10
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CADUET
DailyMed Link:	CADUET at DailyMed

Generic Entry Opportunity Date for CADUET

NDA:

021540

Dosage::

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CADUET

Ingredient-type	Dihydropyridines
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

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

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Expired US Patents for CADUET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004

Paragraph IV (Patent) Challenges for CADUET

Drugname	Dosage	Strength	RLD	Date
	Tablets	2.5 mg/40 mg
	Tablets	5 mg/80 mg
	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

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International Patents for CADUET

Country	Document Number	Estimated Expiration
Australia	755636
Eurasian Patent Organization	003549
Slovenia	1491193
Serbia	50485

Supplementary Protection Certificates for CADUET

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB11/010	United Kingdom		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
30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
00375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE