Escitalopram oxalate - Generic Drug Details

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.

Summary for escitalopram oxalate

International Patents:	56
US Patents:	2
Tradenames:	2
Applicants:	21
NDAs:	25
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	20
Patent Applications:	946
Formulation / Manufacturing:	see details
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

See drug sales revenues for escitalopram oxalate

Recent Clinical Trials for escitalopram oxalate

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 4
NYU Langone Health	Phase 4
Xijing Hospital	N/A

See all escitalopram oxalate clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET; ORAL
		10MG	TABLET; ORAL
		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

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
Torrent Pharms Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	090939-003	Sep 11, 2012	AB	RX	No	No
Amneal Pharms	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	205619-003	May 17, 2017	AB	RX	No	No
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No					Y

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
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002
Allergan	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002

International Patents for escitalopram oxalate

Country	Patent Number	Title	Estimated Expiration
Serbia	8304
Slovenia	1414435
Denmark	1414435
Ukraine	79930	CRYSTALLINE COMPOSITION CONTAINING ESCITALOPRAM

Supplementary Protection Certificates for escitalopram oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0347066	SPC/GB02/049	United Kingdom		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		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		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		PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207