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LEXAPRO Drug Profile

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When do Lexapro patents expire, and when can generic versions of Lexapro launch?

Lexapro is a drug marketed by Allergan Sales Llc 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. Fifty-three suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for LEXAPRO

International Patents:	56
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	12
Bulk Api Vendors:	89
Clinical Trials:	75
Patent Applications:	3,089
Drug Prices:	see details
DailyMed Link:	LEXAPRO at DailyMed

Pharmacology for LEXAPRO

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Synonyms for LEXAPRO

(+)-(S)-1-(3-(Dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile

(+)-(S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile oxalate

(+)-(S)-Citalopram

(+)-(S)-Citalopram oxalate

(+)-Citalopram

(1r)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-3h-isobenzofuran-5-carbonitrile

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile

(1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile Ethanedioate

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile; oxalic acid

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile;oxalic acid

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-isobenzofuran-5-carbonitrile

(1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-isobenzofuran-5-carbonitrile; oxalic acid

(S)-(+)-1-[3-(dimethylamino) propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile

(S)-(+)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile

(S)-(+)-Citalopram Oxalate

(S)-(+)Citalopram oxalate

(s)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile

(S)-1-(3-(Dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate

(s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5 carbonitrile

(S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Oxalate

(S)-Citalopram

(S)-Citalopram Oxalate

1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile

118335-EP2275420A1

118335-EP2298764A1

118335-EP2298765A1

128196-01-0

219861-08-2

4O4S742ANY

5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1S)-

5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1S)-, ethanedioate (1:1)

5U85DBW7LO

68P

861E082

AB0012102

AB00698374_10

AB00698374-07

AB00698374-09

AC-4508

AC-6770

AC1L3TGW

AC1L3TGZ

AJ-45648

AK138215

AK322039

AKOS016340275

AKOS017343470

AN-11923

AN-13009

AN-14764

AN-9671

AOB4715

API0010346

AX8019428

BDBM50302225

BG0433

BIDD:PXR0135

BRD-K70301876-034-02-0

BSPBio_002644

C22H23FN2O5

CAS-219861-08-2

cc-372

CCG-39559

CHEBI:36791

CHEMBL1200322

CHEMBL1508

Cipralex

Cipralex (TN)

Citalopram Oxalate

CPD000469191

CS-2053

CS-2054

CTK8E9353

D02567

D07913

D08RBC

DB01175

DR001465

DSSTox_CID_26003

DSSTox_GSID_46003

DSSTox_RID_81282

DTXSID1046003

DTXSID8048440

E0958

EBD32686

Entact

Escitalopram

Escitalopram (INN)

Escitalopram (oxalate)

Escitalopram [INN:BAN]

Escitalopram [INN]

Escitalopram for system suitability, EuropePharmacopoeia (EP) Reference Standard

Escitalopram oxalate

Escitalopram oxalate (JAN/USAN)

Escitalopram oxalate [USAN:USP]

Escitalopram oxalate [USAN]

escitalopram oxalate inn

Escitalopram oxalate, >=98% (HPLC), powder

Escitalopram oxalate, EuropePharmacopoeia (EP) Reference Standard

Escitalopram oxalate, United States Pharmacopeia (USP) Reference Standard

escitalopramum

Esertia

Esertia (TN)

FT-0650410

FT-0660873

Gaudium

GTPL7177

HE305186

HMS2051D11

HMS2089O08

HMS2231M16

HMS3370I17

HMS3393D11

HY-14258

HY-14258A

J-005570

J90016

KB-62485

KBio2_001881

KBio2_004449

KBio2_007017

KBio3_001864

KBioGR_001644

KBioSS_001881

KS-1263

KTGRHKOEFSJQNS-BDQAORGHSA-N

Lexapro (TN)

Lopac-C-7861

LS-183517

LS-183519

Lu 26-054-0

Lu-26-054-0

LU-260540

MFCD06407826

MLD-55

MLS001401408

MolPort-003-666-613

MRF-0000226

NC00194

NCGC00015267-01

NCGC00015267-02

NCGC00015267-03

NCGC00015267-06

NCGC00025160-01

NCGC00095903-01

NCGC00178555-01

NCGC00178555-02

NSC-758934

NSC758934

Pharmakon1600-01505216

R-Citalopram

RT-012495

S-(+)-1-(3-(Dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate

S-(+)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile oxalate

S-(+)-5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, oxalate

S-(+)-Citalopram

S-(+)-Citalopram oxalate

S(+)-Citalopram

SAM001246668

SC-47288

SCHEMBL34948

SCHEMBL35123

Seroplex

SMR000469191

SPBio_000621

Spectrum_001401

SPECTRUM1505216

Spectrum2_000551

Spectrum3_001062

Spectrum4_001212

Spectrum5_001693

ST24046691

TL8001823

Tocris-1427

Tox21_111535

Tox21_111535_1

UNII-0DHU5B8D6V component WSEQXVZVJXJVFP-FQEVSTJZSA-N

UNII-4O4S742ANY

UNII-5U85DBW7LO

UNII-B5RDX2419X component KTGRHKOEFSJQNS-BDQAORGHSA-N

WSEQXVZVJXJVFP-FQEVSTJZSA-N

ZINC3800706

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 Sales Llc	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002	AA	RX	Yes	Yes
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	AB	RX	Yes	Yes					Y
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No					Y
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	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 Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002

Paragraph IV (Patent) Challenges for LEXAPRO

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	5 mg		2005-08-17
	Capsules	10 mg and 20 mg		2005-03-30

International Patents for LEXAPRO

Country	Document Number	Estimated Expiration
Croatia	P20080410
Eurasian Patent Organization	200400243
China	1536997
Japan	2005525993

Supplementary Protection Certificates for LEXAPRO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
399030	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
/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
00155	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
02C/039	Belgium		PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207