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Generated: September 23, 2019

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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, Cadila, Hikma Pharms, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Pharm Assoc, Prinston Inc, Teva Pharms Usa, and Torrent Pharms Ltd, 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. Forty-eight 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
128196-01-0
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
AKOS016340275
AN-13009
AN-9671
AOB4715
AX8019428
BCP05686
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, >=98% (HPLC), powder
Escitalopram oxalate, EuropePharmacopoeia (EP) Reference Standard
Escitalopram Oxalate, Pharmaceutical Secondary Standard; Certified Reference Material
Escitalopram oxalate, United States Pharmacopeia (USP) Reference Standard
Escitalopram pound Escitalopram Oxalate pound(c)
Esertia
FT-0650410
Gaudium
HMS2051D11
HMS2231M16
HMS3370I17
HMS3393D11
HMS3713D16
HY-14258A
J90016
KS-1263
KTGRHKOEFSJQNS-BDQAORGHSA-N
Lexapro
Lexapro (TN)
LS-183519
Lu 26-054-0
Lu-26-054-0
LU-260540
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
SAM001246668
SB17454
SCHEMBL35123
SMR000469191
SPECTRUM1505216
SR-01000763053
SR-01000763053-3
ST24046691
TL8001823
Tox21_111535
Tox21_111535_1
UNII-5U85DBW7LO
UNII-B5RDX2419X component KTGRHKOEFSJQNS-BDQAORGHSA-N
Generic filers with 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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Aurobindo Pharma Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 090432-001 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078777-003 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc ESCITALOPRAM OXALATE escitalopram oxalate CAPSULE;ORAL 077660-002 Jul 31, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078604-001 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Macleods Pharms Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 202210-001 Sep 11, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cadila ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 077734-002 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

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

Supplementary Protection Certificates for escitalopram oxalate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0347066 SPC/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
0347066 42/2002 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
0347066 10399030 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
0347066 2002C/039 Belgium ➤ Sign Up PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207
0347066 C300155 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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