FDA Orange Book · active-ingredient family
Bisoprolol fumarate
Bisoprolol fumarate: 1 brand, 13 generics; first approved Jul 31, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
29
Brand (NDA) products
Originator applications
- ZEBETARLDTEVA BRANDED PHARMNDA 01998219922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- BISOPROLOL FUMARATEMICRO LABSANDA 21830320262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEUNIQUE PHARMANDA 21904420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATERUBICON RESEARCHANDA 07564320253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx — - BISOPROLOL FUMARATEHARMAN FINOCHEMANDA 21761720242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEPRINSTON INCANDA 21736820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEZYDUS LIFESCIENCESANDA 21568020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATENOVITIUM PHARMAANDA 21556320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEALEMBICANDA 20489120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEUNICHEMANDA 07863520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATEAUROBINDO PHARMAANDA 07791020062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATENATCO PHARMA USAANDA 07583120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - BISOPROLOL FUMARATETP ANDA HOLDINGSANDA 07547420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BISOPROLOL FUMARATETEVA PHARMSANDA 07564420012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG 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
34 yr 7 mo ago
Most recent approval
5 mo ago
Approvals span 1992–2026 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Bisoprolol fumarate: 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.
