FDA Orange Book · active-ingredient family
Bicalutamide
Bicalutamide: 1 brand, 13 generics; first approved Oct 04, 1995; 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
14
Brand (NDA) products
Originator applications
- ANI PHARMSNDA 0204981995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
Generic (ANDA) products (13)
Abbreviated applications
- BICALUTAMIDECHARTWELL RXANDA 0910112015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDEAPOTEXANDA 2002742015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDEROXANEANDA 0782852011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDEFRESENIUS KABI USAANDA 0790452010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDEWATSON LABS TEVAANDA 0786342009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDEACCORD HLTHCAREANDA 0789172009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDEADAPTISANDA 0790892009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDEKUDCO IRELANDANDA 0779952009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDERISINGANDA 0791852009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDESANDOZANDA 0785752009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDESUN PHARMANDA 0791102009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - BICALUTAMIDESYNTHON PHARMSANDA 0779732009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - BICALUTAMIDETEVAANDA 0769322009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG 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
31 yr 4 mo ago
Most recent approval
11 yr 5 mo ago
Approvals span 1995–2015 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Bicalutamide: 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.
