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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caduet

A generic version of Caduet was approved as amlodipine besylate; atorvastatin calcium by MYLAN on November 29^th, 2013.

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Summary for Caduet

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	13
Patent Applications:	2,513
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Caduet
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Caduet
What excipients (inactive ingredients) are in Caduet?	Caduet excipients list
DailyMed Link:	Caduet at DailyMed

Drug patent expirations by year for Caduet

Recent Clinical Trials for Caduet

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hyo-Soo Kim	Phase 4
Kosin University Gospel Hospital	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all Caduet clinical trials

Pharmacology for Caduet

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for Caduet

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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

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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
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
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	⤷ Try a Trial	⤷ Try a Trial
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-007	Jan 30, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for Caduet

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

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Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	P20002029	(54) Crystalline [R-(R,R,]-2-(4-Fluorophenyl)-Beta,Delta-Dihydroxy-5-(1-Methyl-Ethyl)-3-Phenyl-4-{Phenylamino) Carbonyl} - 1H - Pyrrole - 1 - Heptanoic Acid Hemi Calcium Salt (Atorvastatin)	⤷ Try a Trial
Romania	120070	FORME CRISTALINE ALE SĂRII SEMICALCICE A ACIDULUI\| [(R-(R, R)]-2-(4-FLUOROFENIL)-BETA-DELTA-DIHIDROXI-5-(1-METILETIL)-3-FENIL-4-[(FENILAMINO)CARBONIL]-1H-PIROL-1-HEPTANOIC (ATORVASTATIN) (CRYSTALLINE FORMS OF [R-(R,R)]-2-(4-FLUOROPHENYL)-BETA, DELTA-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN))	⤷ Try a Trial
Japan	2014051533	PROCESS FOR PREPARATION OF CRYSTALLINE [R-(R,R)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID (ATORVASTATIN)	⤷ Try a Trial
Hong Kong	16288	DIHYDROPYRIDINE ANTI-ISCHAEMIC AND ANTIHYPERTENSIVE AGENTS,PROCESSES FOR THEIR PRODUCTION,AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM	⤷ Try a Trial
Peru	107199	COMBINACIONES TERAPEUTICAS DE AMLODIPINA Y ATORVASTATINA	⤷ Try a Trial
Malaysia	123993	THERAPEUTIC COMBINATIONS	⤷ Try a Trial
Mexico	9203095	INHIBIDORES DE TRANS-6-[2-(3- O 4-CARBOXAMIDO-PIRROLSUBSTITUIDO-1-ILALQUIL]-4-HIDROXIPIRAN-2-ONA DE SINTESIS DE COLESTEROL.	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for Caduet

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0503785	C300375	Netherlands	⤷ Try a Trial	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
1915993	92315	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0502314	C300478	Netherlands	⤷ Try a Trial	PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
1003503	91253	Luxembourg	⤷ Try a Trial	91253, EXPIRES: 20200707
0502314	SPC/GB11/010	United Kingdom	⤷ Try a Trial	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
0247633	SPC/GB97/011	United Kingdom	⤷ Try a Trial	SPC/GB97/011: 20070529, EXPIRES: 20111106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for Caduet

Recent Clinical Trials for Caduet

Pharmacology for Caduet

Anatomical Therapeutic Chemical (ATC) Classes for Caduet

Paragraph IV (Patent) Challenges for CADUET

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