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Details for Generic Name: amlodipine besylate; atorvastatin calcium

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Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Mylan Pharms Inc, and Pfizer, and is included in three NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-nine patent family members in forty-five countries.

There are forty-seven drug master file entries for amlodipine besylate; atorvastatin calcium. Five suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; atorvastatin calcium

Tradenames:2
Patents:3
Applicants:3
NDAs:3
Drug Master File Entries: see list47
Suppliers / Packaging: see list95
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; atorvastatin calcium

Clinical Trials for: amlodipine besylate; atorvastatin calcium

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Status: Completed Condition: Healthy

Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects
Status: Not yet recruiting Condition: Healthy

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
Status: Completed Condition: Dyslipidemia; Hypertension

Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Status: Completed Condition: Hypertension; Angina Pectoris; Hypercholesterolemia; Familial Hypercholesterolemia

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin.
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
Status: Recruiting Condition: Arterial and Arteriolar Disorders

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 2004RXNo5,686,104*PED<disabled>Y<disabled>
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-002Nov 29, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-011Nov 29, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL200465-009Nov 29, 2013RXNo<disabled><disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 2004RXNo6,455,574<disabled><disabled>
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International Patent Family for Ingredient: amlodipine besylate; atorvastatin calcium

Country Document Number Publication Date
Germany69826683Nov 04, 2004
Georgia, Republic ofP20084338Mar 25, 2008
Australia755636Dec 19, 2002
Iceland5343Jan 14, 2000
Algeria2596Feb 22, 2003
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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