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Generated: July 15, 2018

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 three suppliers. There is one patent 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. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
Summary for 021540
Tradename:CADUET
Applicant:Pfizer
Ingredient:amlodipine besylate; atorvastatin calcium
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021540
Generic Entry Date for 021540*:
Constraining patent/regulatory exclusivity:
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 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 N 0069-2150-30
CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540 NDA Pfizer Laboratories Div Pfizer Inc 0069-2160 N 0069-2160-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 10MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 11, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 20MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 11, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 40MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 11, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION

Expired US Patents for NDA 021540

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-011 Jul 29, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-003 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-011 Jul 29, 2004 ➤ Sign Up ➤ Sign Up
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Healthtrust
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Dow
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