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Last Updated: March 29, 2020

DrugPatentWatch Database Preview

AVODART Drug Profile


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Which patents cover Avodart, and when can generic versions of Avodart launch?

Avodart is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in AVODART is dutasteride. There are eighteen drug master file entries for this compound. Additional details are available on the dutasteride profile page.

US ANDA Litigation and Generic Entry Outlook for Avodart

A generic version of AVODART was approved as dutasteride by BARR on December 21st, 2010.

  Start Trial

Drug patent expirations by year for AVODART
Drug Prices for AVODART

See drug prices for AVODART

Drug Sales Revenue Trends for AVODART

See drug sales revenues for AVODART

Recent Clinical Trials for AVODART

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

SponsorPhase
Addpharma Inc.Phase 1
UConn HealthPhase 2/Phase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2/Phase 3

See all AVODART clinical trials

Recent Litigation for AVODART

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 AVODART litigation

Synonyms for AVODART
(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 (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
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 AVODART
Tradename Dosage Ingredient NDA Submissiondate
AVODART CAPSULE;ORAL dutasteride 021319 2007-10-29

US Patents and Regulatory Information for AVODART

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 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 AVODART

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

Supplementary Protection Certificates for AVODART

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0719278 03C0030 France   Start Trial PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
0719278 300122 Netherlands   Start Trial
0719278 23/2003 Austria   Start Trial PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0719278 C300122 Netherlands   Start Trial PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719
0719278 PA2003007,C0719278 Lithuania   Start Trial PRODUCT NAME: DUTASTERIDUM (17BETA-N(2,5-BIS(TRIFLUORMETIL)FENILKARBAMOIL-4-AZA-5ALFA-ANDROST-1-EN-3-ONAS), PASIRINKTINAI FARMACISKAI TINKAMO SOLVATO FORMOJE; REGISTRATION NO/DATE: 03/8183/7 20030909
0719278 SPC/GB03/018 United Kingdom   Start Trial PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
0719278 SPC009/2005 Ireland   Start Trial SPC009/2005: 20060316, EXPIRES: 20170718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Baxter
Medtronic
Merck
Moodys

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