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Last Updated: March 29, 2020

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Dutasteride - Generic Drug Details

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What are the generic drug sources for dutasteride and what is the scope of patent protection?

Dutasteride is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Actavis Labs Fl Inc, Amneal Pharms, Apotex Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Bionpharma Inc, Breckenridge, Cadila, Heritage Pharms Inc, Hikma, Humanwell Puracap, Intergel Pharms Inc, Marksans Pharma, Mylan, PII, Rising, Strides Pharma, Vintage Pharms Llc, Anchen Pharms, and Zydus Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for dutasteride.

Drug Prices for dutasteride

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Drug Sales Revenue Trends for dutasteride

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Recent Clinical Trials for dutasteride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Beth Israel Deaconess Medical CenterN/A
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2/Phase 3
UConn HealthPhase 2/Phase 3

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Recent Litigation for dutasteride

Identify potential future generic entrants

District Court Litigation
Case NameDate
GlaxoSmithKline LLC v. Apotex Inc.2012-08-31
GlaxoSmithKline LLC v. Roxane Laboratories Inc.2011-06-17
GlaxoSmithKline LLC v. Banner Pharmacaps Inc.2011-01-12

See all dutasteride litigation

Medical Subject Heading (MeSH) Categories for dutasteride
Synonyms for dutasteride
(1S,2R,7R,10S,11S,14S,15S)-N-[2,5-bis(trifluoromethyl)phenyl]-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-3-ene-14-carboxamide
(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(2,5-Bis(trifluoromethyl)phenyl)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno[5,4-f]quinoline-7-carboxamide
(5.alpha.,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide;dutasteride;Avodart;
(5|A,17|A)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-l-ene-17-carboxamide
(5alpha,17beta)-N-(2,5-Bis(trifluoromethyl)phenyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
(5alpha,17beta)-N-{2,5-bis(trifluoromethyl)-phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide
164656-23-9
1H-Indeno(5,4-f)quinoline-7-carboxamide, N-(2,5-bis(trifluoromethyl)phenyl)-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4aR,4bS,6aS,7S,9aS,9bS,11aR)-
1H-Indeno[5,4-f]quinoline-7-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4aR,4bS,6aS,7S,9aS,9bS,11aR)-
656D239
AB01274774_02
AB01274774-01
AB1009276
AKOS015920136
AKOS015924431
alpha,alpha,alpha,alpha',alpha',alpha'-Hexafluoro-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxy-2',5'-xylidide
AOB5568
Avidart
Avodart
Avodart (TN)
Avolve
B-2151
BCP02344
BCP9000630
BCPP000248
BDBM50340481
BR-72895
BRD-K30373883-001-02-8
C-23099
C27H30F6N2O2
CAS-164656-23-9
CC-27419
CHEBI:521033
CHEMBL1200969
CS-1542
D03820
DB01126
DSSTox_CID_26452
DSSTox_GSID_46452
DSSTox_RID_81626
DTXSID8046452
Duagen
Dutasteride (JAN/USAN/INN)
Dutasteride [USAN:INN:BAN]
Dutasteride for system suitability, European Pharmacopoeia (EP) Reference Standard
Dutasteride, >=98% (HPLC)
Dutasteride, 99%
Dutasteride, European Pharmacopoeia (EP) Reference Standard
Dutasteride, United States Pharmacopeia (USP) Reference Standard
EX-A1952
FT-0080365
GG 745
GG-745
GI 198745
GI-198745
GI-198745X
GI198745
GS-3565
GTPL7457
HY-13613
J10036
JWJOTENAMICLJG-QWBYCMEYSA-N
MCULE-1602474627
N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide
NCGC00164571-01
NSC-740477
NSC740477
O0J6XJN02I
Q-201052
Q424760
s1202
SC-08812
SCHEMBL5903
ST24026289
Tox21_112199
UNII-O0J6XJN02I
Z1563146168
ZINC3932831
Paragraph IV (Patent) Challenges for DUTASTERIDE
Tradename Dosage Ingredient NDA Submissiondate
AVODART CAPSULE;ORAL dutasteride 021319 2007-10-29

US Patents and Regulatory Information for dutasteride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intergel Pharms Inc DUTASTERIDE dutasteride CAPSULE;ORAL 206373-001 Mar 17, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma DUTASTERIDE dutasteride CAPSULE;ORAL 204262-001 Nov 20, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc DUTASTERIDE dutasteride CAPSULE;ORAL 207935-001 Oct 13, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge DUTASTERIDE dutasteride CAPSULE;ORAL 204705-001 Nov 20, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dutasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Harvard Business School
Dow
Boehringer Ingelheim
Johnson and Johnson

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