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Last Updated: November 21, 2024

Eprosartan mesylate - Generic Drug Details


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What are the generic drug 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 Norvium Bioscience 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
Recent Clinical Trials for eprosartan mesylate

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

SponsorPhase
Quintiles, Inc.Phase 3
AbbottPhase 3
author! et al. BVPhase 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
Abbvie TEVETEN HCT eprosartan mesylate; hydrochlorothiazide TABLET;ORAL 021268-001 Nov 1, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience EPROSARTAN MESYLATE eprosartan mesylate TABLET;ORAL 202012-002 Nov 16, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-004 Dec 22, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie TEVETEN eprosartan mesylate TABLET;ORAL 020738-005 Dec 22, 1997 DISCN Yes 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 eprosartan mesylate

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

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