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Serving 500+ biopharmaceutical companies globally:

Medtronic
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US Army
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021540

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NDA 021540 describes CADUET, which is a drug marketed by Pfizer and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the CADUET profile page.

The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Summary for NDA: 021540

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021540

Suppliers and Packaging for NDA: 021540

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL 021540 NDA Pfizer Laboratories Div Pfizer Inc 0069-2150 0069-2150-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-2150-30)
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL 021540 NDA Pfizer Laboratories Div Pfizer Inc 0069-2160 0069-2160-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-2160-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 10MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:5,969,156*PEDPatent Expiration:Jan 8, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,455,574Patent Expiration:Aug 11, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 20MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:5,969,156*PEDPatent Expiration:Jan 8, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021540

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 2004RE40667*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 20044,572,909*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-006Jan 30, 20045,969,156*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-011Jul 29, 20045,273,995*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 20045,273,995*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Medtronic
AstraZeneca
McKinsey
Chubb
Novartis
QuintilesIMS
McKesson
Julphar
Accenture
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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