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Last Updated: March 28, 2024

ESCITALOPRAM OXALATE - Generic Drug Details


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What are the generic drug sources for escitalopram oxalate and what is the scope of 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, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Abbvie, Accord Hlthcare, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Lupin Ltd, Pharm Assoc, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for escitalopram oxalate. Fifty-one 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
Sultan Qaboos UniversityPhase 4
National Institute on Aging (NIA)Phase 4
NYU Langone HealthPhase 4

See all ESCITALOPRAM OXALATE clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial20MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 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
Invagen Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078604-001 Sep 11, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Graviti Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078777-003 Sep 11, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent Pharms Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 090939-002 Sep 11, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Pharms ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078766-002 Sep 11, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 090432-003 Sep 11, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Abbvie LEXAPRO escitalopram oxalate SOLUTION;ORAL 021365-001 Nov 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-002 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-003 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LEXAPRO escitalopram oxalate TABLET;ORAL 021323-001 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.