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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Daiichi Sankyo
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Farmers Insurance
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021365

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NDA 021365 describes LEXAPRO, which is a drug marketed by Forest Labs and is included in two NDAs. It is available from fifteen 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-five drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 021365

Therapeutic Class:Antidepressants

Pharmacology for NDA: 021365

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021365

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
escitalopram oxalate
SOLUTION;ORAL 021365 NDA Allergan, Inc. 0456-2101 0456-2101-08 240 mL in 1 BOTTLE (0456-2101-08)
escitalopram oxalate
SOLUTION;ORAL 021365 NDA Actavis Pharma, Inc. 0591-4151 0591-4151-38 240 mL in 1 BOTTLE (0591-4151-38)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Nov 27, 2002TE:AARLD:Yes

Expired Orange Book Patents for NDA: 021365

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
escitalopram oxalate
SOLUTION;ORAL021365-001Nov 27, 2002RE34712*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Chinese Patent Office
US Army
US Department of Justice

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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