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FDA Orange Book · active-ingredient family

Dutasteride

Dutasteride is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AVODART · NDA 021319

1

Brand (NDA)

19

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
AVODARTRLDWAYLIS THERAPNDA 021319ABNov 20, 2001

Generic (ANDA) products (19)

ProductApplicantApplicationTEApproved
DUTASTERIDESTRIDES PHARMAANDA 208227—Jun 22, 2018
DUTASTERIDEHUMANWELL PURACAPANDA 209909ABNov 21, 2017
DUTASTERIDEHERITAGE PHARMS INCANDA 207935—Oct 13, 2017
DUTASTERIDEZYDUS LIFESCIENCESANDA 204373ABOct 04, 2017
DUTASTERIDEADAPTISANDA 204376ABApr 07, 2017
DUTASTERIDEASCENT PHARMS INCANDA 206574ABOct 21, 2016
DUTASTERIDEPHARMOBEDIENTANDA 203241—Jun 14, 2016
DUTASTERIDEACELLAANDA 206373ABMar 17, 2016
DUTASTERIDEAPOTEXANDA 204292—Nov 24, 2015
DUTASTERIDEHIKMAANDA 202204—Nov 23, 2015
DUTASTERIDEACTAVIS LABS FL INCANDA 202808—Nov 20, 2015
DUTASTERIDEAMNEAL PHARMSANDA 203118ABNov 20, 2015
DUTASTERIDEAUROBINDO PHARMA LTDANDA 202660ABNov 20, 2015
DUTASTERIDECHARTWELLANDA 200899ABNov 20, 2015
DUTASTERIDEONESOURCE SPECIALTYANDA 204262ABNov 20, 2015
DUTASTERIDEPH HEALTHANDA 202421—Nov 20, 2015
DUTASTERIDEPHARMOBEDIENTANDA 204705—Nov 20, 2015
DUTASTERIDERISINGANDA 202530—Nov 20, 2015
DUTASTERIDEBARRANDA 090095ABDec 21, 2010

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.

Dutasteride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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