Amlodipine besylate; atorvastatin calcium - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; atorvastatin calcium and what is the scope of patent protection?

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Mylan, Zydus Pharms, and Pharmacia, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for amlodipine besylate; atorvastatin calcium

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate; atorvastatin calcium
DailyMed Link:	amlodipine besylate; atorvastatin calcium at DailyMed

Recent Clinical Trials for amlodipine besylate; atorvastatin calcium

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Dr. Reddy's Laboratories Limited	Phase 1

See all amlodipine besylate; atorvastatin calcium clinical trials

Pharmacology for amlodipine besylate; atorvastatin calcium

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 amlodipine besylate; atorvastatin calcium

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 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

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 amlodipine besylate; atorvastatin calcium

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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
Dr Reddys	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	203874-002	Mar 7, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	203874-001	Mar 7, 2014	AB	RX	No	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 amlodipine besylate; atorvastatin calcium

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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	⤷ Sign Up	⤷ Sign Up
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-007	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-003	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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