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 Norvium Bioscience, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Abbvie, Accord Hlthcare, Anima, Chartwell Rx, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, 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.

Summary for escitalopram oxalate

US Patents:	0
Tradenames:	2
Applicants:	21
NDAs:	25
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	21
Patent Applications:	984
Drug Prices:	Drug price trends for escitalopram oxalate
Drug Sales Revenues:	Drug sales revenues for escitalopram oxalate
What excipients (inactive ingredients) are in escitalopram oxalate?	escitalopram oxalate excipients list
DailyMed Link:	escitalopram oxalate at DailyMed

See drug prices for escitalopram oxalate

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

Sponsor	Phase
Sultan Qaboos University	Phase 4
NYU Langone Health	Phase 4
National Institute on Aging (NIA)	Phase 4

See all escitalopram oxalate clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	20MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET; 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

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for escitalopram oxalate

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	079121-001	May 3, 2012	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	202210-002	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
Zydus Lifesciences	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	077734-001	Sep 11, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	202754-001	Mar 31, 2016	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	076765-001	Mar 14, 2012		DISCN	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

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

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