Eprosartan mesylate - Generic Drug Details

What are the generic sources for eprosartan mesylate and what is the scope of freedom to operate?

Eprosartan mesylate is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc and Abbvie, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for eprosartan mesylate.

Summary for eprosartan mesylate

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	9
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	1
Patent Applications:	2,227
Formulation / Manufacturing:	see details
DailyMed Link:	eprosartan mesylate at DailyMed

Recent Clinical Trials for eprosartan mesylate

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

Sponsor	Phase
Quintiles, Inc.	Phase 3
Abbott	Phase 3
author! et al. BV	Phase 3

See all eprosartan mesylate clinical trials

Paragraph IV (Patent) Challenges for EPROSARTAN MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEVETEN	Tablets	eprosartan mesylate	400 mg and 600 mg	020738	1	2010-05-10

US Patents and Regulatory Information for eprosartan mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	EPROSARTAN MESYLATE	eprosartan mesylate	TABLET;ORAL	202012-002	Nov 16, 2011		DISCN	No	No
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-005	Dec 22, 1997		DISCN	Yes	No
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-006	May 27, 1999		DISCN	Yes	No
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-002	Nov 1, 2001		DISCN	No	No
Mylan Pharms Inc	EPROSARTAN MESYLATE	eprosartan mesylate	TABLET;ORAL	202012-001	Nov 16, 2011		DISCN	No	No
Abbvie	TEVETEN HCT	eprosartan mesylate; hydrochlorothiazide	TABLET;ORAL	021268-001	Nov 1, 2001		DISCN	No	No
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-004	Dec 22, 1997		DISCN	No	No

Expired US Patents for eprosartan mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-005	Dec 22, 1997
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-005	Dec 22, 1997
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-006	May 27, 1999
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-004	Dec 22, 1997
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-006	May 27, 1999
Abbvie	TEVETEN	eprosartan mesylate	TABLET;ORAL	020738-004	Dec 22, 1997