FDA Orange Book · active-ingredient family
Dutasteride
Dutasteride: 1 brand, 19 generics; first approved Nov 20, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
19
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- WAYLIS THERAPNDA 0213192001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB
Generic (ANDA) products (19)
Abbreviated applications
- DUTASTERIDESTRIDES PHARMAANDA 2082272018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEHUMANWELL PURACAPANDA 2099092017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEHERITAGE PHARMS INCANDA 2079352017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEZYDUS LIFESCIENCESANDA 2043732017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEADAPTISANDA 2043762017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEASCENT PHARMS INCANDA 2065742016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEPHARMOBEDIENTANDA 2032412016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEACELLAANDA 2063732016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEAPOTEXANDA 2042922015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEHIKMAANDA 2022042015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEACTAVIS LABS FL INCANDA 2028082015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEAMNEAL PHARMSANDA 2031182015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEAUROBINDO PHARMA LTDANDA 2026602015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDECHARTWELLANDA 2008992015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEONESOURCE SPECIALTYANDA 2042622015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB - DUTASTERIDEPH HEALTHANDA 2024212015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEPHARMOBEDIENTANDA 2047052015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDERISINGANDA 2025302015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Discontinued — - DUTASTERIDEBARRANDA 0900952010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG CAPSULE ORAL Rx AB
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
25 yr 1 mo ago
Most recent approval
8 yr 3 mo ago
Approvals span 2001–2018 across 20 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1995%
Dutasteride: 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.
