FDA Orange Book · active-ingredient family
Bisoprolol fumarate
Bisoprolol fumarate is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZEBETA · NDA 019982
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEBETARLD×2 | TEVA BRANDED PHARM | NDA 019982 | — | Jul 31, 1992 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BISOPROLOL FUMARATE×2 | MICRO LABS | ANDA 218303 | AB | Mar 09, 2026 | |
| BISOPROLOL FUMARATE×2 | UNIQUE PHARM | ANDA 219044 | AB | Apr 16, 2025 | |
| BISOPROLOL FUMARATE×3 | RUBICON RESEARCH | ANDA 075643 | — | Mar 07, 2025 | |
| BISOPROLOL FUMARATE×2 | HARMAN FINOCHEM | ANDA 217617 | AB | Jan 18, 2024 | |
| BISOPROLOL FUMARATE×2 | PRINSTON INC | ANDA 217368 | AB | Jul 14, 2023 | |
| BISOPROLOL FUMARATE×2 | ZYDUS LIFESCIENCES | ANDA 215680 | AB | Jul 25, 2022 | |
| BISOPROLOL FUMARATE×2 | NOVITIUM PHARMA | ANDA 215563 | AB | Oct 29, 2021 | |
| BISOPROLOL FUMARATE×2 | ALEMBIC | ANDA 204891 | AB | Jan 11, 2017 | |
| BISOPROLOL FUMARATE×2 | UNICHEM | ANDA 078635 | AB | Aug 18, 2009 | |
| BISOPROLOL FUMARATE×2 | AUROBINDO PHARMA | ANDA 077910 | AB | Dec 27, 2006 | |
| BISOPROLOL FUMARATE×2 | NATCO PHARMA USA | ANDA 075831 | — | Dec 14, 2005 | |
| BISOPROLOL FUMARATE×2 | TP ANDA HOLDINGS | ANDA 075474 | AB | Oct 25, 2002 | |
| BISOPROLOL FUMARATE×2 | TEVA PHARMS | ANDA 075644 | — | Jun 26, 2001 |
Listed patents
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.
Bisoprolol fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
