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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021323

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NDA 021323 describes LEXAPRO, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from nine suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEXAPRO profile page.

The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 021323
Tradename:LEXAPRO
Applicant:Allergan Sales Llc
Ingredient:escitalopram oxalate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021323
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXAPRO escitalopram oxalate TABLET;ORAL 021323 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-3856 0378-3856-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3856-10)
LEXAPRO escitalopram oxalate TABLET;ORAL 021323 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-3857 0378-3857-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3857-10)
Paragraph IV (Patent) Challenges for 021323
Tradename Dosage Ingredient NDA Submissiondate
LEXAPRO TABLET;ORAL escitalopram oxalate 021323 2005-08-17
LEXAPRO TABLET;ORAL escitalopram oxalate 021323 2005-03-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 14, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 14, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021323

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002   Start Trial   Start Trial
Allergan Sales Llc LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002   Start Trial   Start Trial
Allergan Sales Llc LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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