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Escitalopram oxalate - Generic Drug Details

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What are the generic drug sources for escitalopram oxalate and what is the scope of escitalopram oxalate freedom to operate?

Escitalopram oxalate is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Macleods Pharms Ltd, Taro, Allergan Sales Llc, Accord Hlthcare, Apotex Inc, Hikma Pharms, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Sti Pharma Llc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in twenty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Escitalopram oxalate has fifty-six patent family members in thirty-eight countries.

There are twenty-six drug master file entries for escitalopram oxalate. Sixty-five suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for escitalopram oxalate

International Patents:	56
US Patents:	2
Tradenames:	2
Applicants:	20
NDAs:	25
Drug Master File Entries:	26
Suppliers / Packagers:	65
Bulk Api Vendors:	60
Clinical Trials:	322
Patent Applications:	680
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for escitalopram oxalate
DailyMed Link:	escitalopram oxalate at DailyMed

Pharmacology for escitalopram oxalate

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Synonyms for escitalopram oxalate

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

(+)-(S)-Citalopram oxalate

(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; 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; oxalic acid

(S)-(+)-Citalopram Oxalate

(S)-(+)Citalopram oxalate

(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 Oxalate

(S)-Citalopram Oxalate

219861-08-2

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

5U85DBW7LO

861E082

AB0012102

AC-6770

AC1L3TGZ

AK138215

AKOS016340275

AN-13009

AN-9671

AOB4715

AX8019428

BG0433

C22H23FN2O5

CAS-219861-08-2

cc-372

CCG-39559

CHEMBL1200322

Cipralex

Citalopram Oxalate

CPD000469191

CS-2054

D02567

DSSTox_CID_26003

DSSTox_GSID_46003

DSSTox_RID_81282

DTXSID1046003

E0958

Entact

Escitalopram (oxalate)

Escitalopram for system suitability, EuropePharmacopoeia (EP) Reference Standard

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

FT-0650410

Gaudium

HMS2051D11

HMS2231M16

HMS3370I17

HMS3393D11

HY-14258A

J90016

KS-1263

KTGRHKOEFSJQNS-BDQAORGHSA-N

Lexapro

Lexapro (TN)

LS-183519

Lu 26-054-0

Lu-26-054-0

LU-260540

MFCD06407826

MLD-55

MLS001401408

MolPort-003-666-613

NC00194

NCGC00095903-01

NCGC00178555-02

NSC-758934

NSC758934

Pharmakon1600-01505216

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 oxalate

SAM001246668

SCHEMBL35123

SMR000469191

SPECTRUM1505216

ST24046691

TL8001823

Tox21_111535

Tox21_111535_1

UNII-5U85DBW7LO

UNII-B5RDX2419X component KTGRHKOEFSJQNS-BDQAORGHSA-N

Tentative approvals for ESCITALOPRAM OXALATE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		20MG	TABLET; ORAL
		10MG	TABLET; ORAL

US Patents and Regulatory Information for escitalopram oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent Pharms Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	090939-003	Sep 11, 2012	AB	RX	No	No
Antrim Pharms Llc	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	203967-001	May 26, 2015	AA	RX	No	No
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No					Y
Macleods Pharms Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	202754-001	Mar 31, 2016	AA	RX	No	No

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Expired US Patents for escitalopram oxalate

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	TABLET;ORAL	021323-003	Aug 14, 2002
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002
Allergan Sales Llc	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002

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International Patents for escitalopram oxalate

Country	Document Number	Estimated Expiration
Portugal	1414435
Bulgaria	108571
Uruguay	27404
China	1536997

Supplementary Protection Certificates for escitalopram oxalate

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