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Last Updated: July 7, 2020

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LEXAPRO Drug Profile


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Which patents cover Lexapro, and what generic alternatives are available?

Lexapro is a drug marketed by Allergan and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-six patent family members in thirty-eight countries.

The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

US ANDA Litigation and Generic Entry Outlook for Lexapro

A generic version of LEXAPRO was approved as escitalopram oxalate by AMNEAL PHARMS on March 14th, 2012.

  Start Trial

Drug patent expirations by year for LEXAPRO
Drug Prices for LEXAPRO

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Drug Sales Revenue Trends for LEXAPRO

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Recent Clinical Trials for LEXAPRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alto NeurosciencePhase 4
University of CincinnatiPhase 4
Shanghai Mental Health CenterN/A

See all LEXAPRO clinical trials

Pharmacology for LEXAPRO
Paragraph IV (Patent) Challenges for LEXAPRO
Tradename Dosage Ingredient NDA Submissiondate
LEXAPRO TABLET;ORAL escitalopram oxalate 021323 2005-08-17
LEXAPRO TABLET;ORAL escitalopram oxalate 021323 2005-03-30

US Patents and Regulatory Information for LEXAPRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan LEXAPRO escitalopram oxalate SOLUTION;ORAL 021365-001 Nov 27, 2002 DISCN Yes No   Start Trial   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEXAPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate SOLUTION;ORAL 021365-001 Nov 27, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEXAPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0347066 90999 Luxembourg   Start Trial
0347066 2002C/039 Belgium   Start Trial PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207
0347066 SPC/GB02/049 United Kingdom   Start Trial PRODUCT NAME: ESCITALOPRAM OXALATE; REGISTERED: SE 17084/85/86/87 20011207; UK PL 13761/0008 20020610; UK PC 13761/0009 20020610; UK PL 13761/0010 20020610; UK PL 13761/0011 20020610; UK PL 13761/0012 20020610; UK PL 13761/0013 20020610; UK PL 13761/00014 20020610; UK PL 13761/0015 20020610
0347066 42/2002 Austria   Start Trial PRODUCT NAME: ESCITALOPRAM UND DESSEN NICHT-TOXISCHE SAEUREADDITIONSSALZE; NAT. REGISTRATION NO/DATE: 1-24549, 1-24550, 1-24551, 1-24552 20020618; FIRST REGISTRATION: SE 17084, 17085, 17086,17087 20011207
0347066 C300155 Netherlands   Start Trial PRODUCT NAME: ESCITALOPRAM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER ESCITALOPRAMOXALAAT; REGISTRATION NO/DATE: RVG 30490 - RVG 30497 20040427
0347066 10399030 Germany   Start Trial PRODUCT NAME: ESCITALOPRAMOXALAT; NAT. REGISTRATION NO/DATE: 55880.00.00 55880.01.00 55880.02.00 55880.03.00 55884.00.00 55884.01.00 55884.02.00 55884.03.00 55888.00.00 55888.01.00 55888.02.00 55888.03.00 20030408 FIRST REGISTRATION: SCHWEDEN 17084 17085 17086 17087 20011207
0347066 SZ 42/2002 Austria   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Medtronic
Mallinckrodt
Harvard Business School
McKesson

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