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Last Updated: August 3, 2020

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Escitalopram oxalate - Generic Drug Details

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What are the generic sources for escitalopram oxalate and what is the scope of patent protection?

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, Accord Hlthcare, Cadila, Graviti Pharms, 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-six suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for escitalopram oxalate

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Drug Sales Revenue Trends for escitalopram oxalate

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Recent Clinical Trials for escitalopram oxalate

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

SponsorPhase
Xijing HospitalN/A
GlaxoSmithKlinePhase 3
Guangdong Provincial Hospital of Traditional Chinese MedicineN/A

See all escitalopram oxalate clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MGTABLET; ORAL
  Start Trial  Start Trial10MGTABLET; ORAL
  Start Trial  Start Trial5MGTABLET; ORAL

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

Pharmacology for escitalopram oxalate
Paragraph IV (Patent) Challenges for ESCITALOPRAM OXALATE
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 escitalopram oxalate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078169-001 Sep 11, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Pharm Assoc ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 077512-001 Sep 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 202280-001 Sep 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 205619-002 May 17, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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 LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate SOLUTION;ORAL 021365-001 Nov 27, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002   Start Trial   Start Trial
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002   Start Trial   Start Trial
>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 2002C/039 Belgium   Start Trial 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   Start Trial 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 C300155 Netherlands   Start Trial 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 42/2002 Austria   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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