FDA Orange Book · active-ingredient family
Eprosartan mesylate
Eprosartan mesylate: 1 brand, 1 generic; first approved Dec 22, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- TEVETENRLDABBVIENDA 02073819973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Discontinued — EQ 400MG BASE TABLET ORAL Discontinued — EQ 600MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- EPROSARTAN MESYLATEPHARMOBEDIENTANDA 20201220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — EQ 600MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
29 yr 1 mo ago
Most recent approval
14 yr 11 mo ago
Approvals span 1997–2011 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Eprosartan mesylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
