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Last Updated: November 26, 2022

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-two 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
National Institute on Aging (NIA)Phase 4
NYU Langone HealthPhase 4
Xijing HospitalN/A

See all escitalopram oxalate clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing20MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET; 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 Strength NDA ANDAs Submitted Submissiondate
LEXAPRO Capsules escitalopram oxalate 5 mg 021323 1 2005-08-17
LEXAPRO Capsules escitalopram oxalate 10 mg and 20 mg 021323 1 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
Torrent Pharms Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 090939-002 Sep 11, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Torrent Pharms Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 090939-003 Sep 11, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 205619-003 May 17, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 SOLUTION;ORAL 021365-001 Nov 27, 2002 See Plans and Pricing See Plans and Pricing
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002 See Plans and Pricing See Plans and Pricing
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 See Plans and Pricing See Plans and Pricing
Allergan LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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 10399030 Germany See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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