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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 14^th, 2012.

Summary for LEXAPRO

International Patents:	56
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	71
Clinical Trials:	91
Patent Applications:	520
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LEXAPRO
Drug Sales Revenues:	Drug sales revenues for LEXAPRO
DailyMed Link:	LEXAPRO at DailyMed

See drug prices for LEXAPRO

See drug sales revenues for LEXAPRO

Recent Clinical Trials for LEXAPRO

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

Sponsor	Phase
Alto Neuroscience	Phase 4
University of Cincinnati	Phase 4
Shanghai Mental Health Center	N/A

See all LEXAPRO clinical trials

Pharmacology for LEXAPRO

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

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
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	AB	RX	Yes	Yes					Y
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No					Y
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002	AB	RX	Yes	No					Y
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002	AB	RX	Yes	No					Y
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	AB	RX	Yes	Yes					Y
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No					Y

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
Allergan	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002

International Patents for LEXAPRO

Country	Patent Number	Estimated Expiration
European Patent Office	1522539
Denmark	170280
Finland	20000507
Spain	2233842
Finland	892823
Ukraine	79930
Finland	98627

Supplementary Protection Certificates for LEXAPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0347066	90999	Luxembourg
0347066	2002C/039	Belgium		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		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		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		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		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