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Generated: October 17, 2018

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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.

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

Pharmacology for ESCITALOPRAM OXALATE
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
➤ Sign Up➤ Sign Up20MGTABLET; ORAL
➤ Sign Up➤ Sign Up10MGTABLET; ORAL
➤ Sign Up➤ Sign Up5MGTABLET; 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
Allergan Sales Llc LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Accord Hlthcare ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 202389-002 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc ESCITALOPRAM OXALATE escitalopram oxalate CAPSULE;ORAL 077660-003 Jul 31, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078777-002 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Supplementary Protection Certificates for ESCITALOPRAM OXALATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00155 Netherlands ➤ Sign Up 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 ➤ Sign Up 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
399030 Germany ➤ Sign Up 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 ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Boehringer Ingelheim
Dow
Cipla
Harvard Business School
US Department of Justice
Deloitte
Covington

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