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McKinsey
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Generated: August 16, 2018

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FINASTERIDE - Generic Drug Details

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

Finasteride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Sun Pharma Global, Teva, Zydus Pharms Usa Inc, and Merck, and is included in twenty-four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Finasteride has six patent family members in five countries.

There are fourteen drug master file entries for finasteride. Forty suppliers are listed for this compound.

Pharmacology for FINASTERIDE
Medical Subject Heading (MeSH) Categories for FINASTERIDE
Synonyms for FINASTERIDE
(17beta-(N-tert-butylcarbamoyl)-4-aza-5alpha-androst-1-en-3-one
(1S,2R,7R,10S,11S,14S,15S)-N-tert-butyl-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-3-ene-14-carboxamide
(1S,2R,7R,10S,11S,14S,15S)-N-TERT-BUTYL-2,15-DIMETHYL-5-OXO-6-AZATETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-3-ENE-14-CARBOXAMIDE
(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-isobutyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-tert-butyl-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)-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-CARBOXYLIC ACID TERT-BUTYLAMIDE
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(1,1-dimethylethyl)-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
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(tert-Butyl)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,1
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(tert-butyl)-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
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-tert-butyl-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
(4aR,4bS,6aS,9aS,9bS,11aR)-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-carboxylic acid tert-butylamide
(4aR,6aS,11aR)-4a,6a-Dimethyl-2-oxo-hexadecahydro-indeno[5,4-f]quinoline-7-carboxylic acid tert-butylamide
(4aR,6aS,7S,11aR)-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-carboxylic acid tert-butylamide
(4aR,6aS,7S)-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-carboxylic acid tert-butylamide
(4aR,6aS)-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-carboxylic acid tert-butylamide
(5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
(5ALPHA,17BETA)-N-(1,1-DIMETHYLETHYL)-3-OXO-4-AZAANDROST-1-ENE-17-CARBOXAMIDE
(R)-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-carboxylic acid tert-butylamide
1,(5ALPHA)-ANDROSTAN-4-AZA-3-ONE-17BETA-(N-TERT-BUTYL-CARBOXAMIDE)
17beta-(N-tert-butylcarbamoyl)-4-aza-5 alpha-androst-1-en-3-one
17BETA-(N-TERT-BUTYLCARBAMOYL)-4-AZA-5ALPHA-ANDROST-1-EN-3-ONE
319F267
32329-EP2272827A1
32329-EP2275420A1
32329-EP2280012A2
32329-EP2281815A1
32329-EP2292615A1
32329-EP2295055A2
32329-EP2295416A2
32329-EP2295426A1
32329-EP2295427A1
32329-EP2298748A2
32329-EP2298764A1
32329-EP2298765A1
32329-EP2298768A1
32329-EP2301928A1
32329-EP2301933A1
32329-EP2305640A2
32329-EP2305642A2
32329-EP2305671A1
32329-EP2311453A1
32329-EP2311808A1
32329-EP2311825A1
32329-EP2311827A1
32329-EP2311829A1
32329-EP2311840A1
4-azaandrost-1-ene-17-carboxamide, N -(1,1-dimethylethyl)-3-oxo-,(5(alpha),17(beta))-
4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5alpha, 17beta)-
4-Azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5alpha,17beta)-
4-Azaandrost-1-ene-17-carboxamide,1-dimethylethyl)-3-oxo-, (5.alpha., 17.beta.)-
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-carboxylic acid tert-butylamide
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-carboxylic acid tert-butylamide(Finasteride)
4a,6a,9a-Trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno[5,4-f]quinoline-7-carboxylic acid (Finasteride)
57GNO57U7G
98319-26-7
AB00513901
AB00513901_09
AB00513901-07
AB00513901-08
AB07586
AB1008360
AC1L1MUF
AC1Q5L2C
ACT02599
AJ-45596
AK-72879
AKOS015894916
Alternova (TN)
AN-615
Andozac
Appecia (TN)
BC200264
BCP0726000222
BCP9000685
BCPP000229
BDBM50334788
BPBio1_001027
BR-72879
BRD-K01095011-001-03-5
BRN 4269024
BSPBio_000933
C-34893
C23H36N2O2
Cahill May Roberts Brand of Finasteride
CAS-98319-26-7
CC-28426
CCG-100937
CCRIS 7438
CHEBI:5062
CHEMBL710
Chibro Proscar
Chibro-Proscar
CPD000466304
CS-1767
D00321
D08IWD
DB01216
DBEPLOCGEIEOCV-WSBQPABSSA-N
DSSTox_CID_625
DSSTox_GSID_20625
DSSTox_RID_75699
DTXSID3020625
Eucoprost
Finalo (TN)
Finara (TN)
Finast (TN)
Finasterid (TN)
Finasterid IVAX (TN)
Finasterida
Finasterida [INN-Spanish]
Finasteride (JAN/USP/INN)
Finasteride (Proscar)
Finasteride (USP/INN)
Finasteride [USAN:INN:BAN]
Finasteride [USAN:USP:INN:BAN]
Finasteride for peak identification, European Pharmacopoeia (EP) Reference Standard
Finasteride, >=98% (HPLC), powder
Finasteride, British Pharmacopoeia (BP) Reference Standard
Finasteride, European Pharmacopoeia (EP) Reference Standard
Finasteride, United States Pharmacopeia (USP) Reference Standard
Finasteride, VETRANAL(TM), analytical standard
Finasteridum
Finasteridum [INN-Latin]
Finastid
Finax (TN)
Fincar (TN)
Finpecia
Finpecia (TN)
Frosst Iberica Brand of Finasteride
FT-0082891
Gefina (TN)
GTPL6818
HMS1570O15
HMS2051F09
HMS2090G22
HMS2097O15
HMS2235L23
HSDB 6793
HY-13635
J10122
KS-1058
L-652,931
Lipha Brand of Finasteride
LS-7397
Merck Brand 1 of Finasteride
Merck Brand 2 of Finasteride
Merck Frosst Brand 1 of Finasteride
Merck Frosst Brand 2 of Finasteride
Merck Sharp & Dhome Brand 2 of Finasteride
Merck Sharp & Dohme Brand 1 of Finasteride
MFCD00869737
MK 0906
MK 609
MK 906
MK-0906
MK-906
MK906
MLS000759404
MLS001165768
MLS001424046
MolPort-002-500-272
MSD Brand of Finasteride
MSD Chibropharm Brand of Finasteride
N-(2-Methyl-2-propyl)-3-oxo-4-aza-5-alpha-androst-1-ene-17-beta-carboxamide
N-(2-methyl-2-propyl)-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide
N-tert-Butyl-3-oxo-4-aza-5|A-androst-1-en-17|A-carboxamide; N-(2-Methyl-2-propyl)-3-oxo-4-aza-5|A-androst-1-ene-17|A-carboxamide
N-tert-Butyl-3-oxo-4-aza-5alpha-androst-1-en-17beta-carboxamide
N-tert-Butyl-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide
NC00187
NCGC00016965-01
NCGC00093560-05
NCGC00256334-01
NCGC00259057-01
NSC-741485
NSC741485
PL001776
Prestwick0_000717
Prestwick1_000717
Prestwick2_000717
Prestwick3_000717
Propecia
Propecia (TN)
Propeshia
Proscar
Proscar (TN)
Proscar, Propecia, Finasteride
Prosteride
Prosteride (TN)
Prostide
s1197
SC-12178
SCHEMBL5509
SMR000466304
SPBio_002854
SR-01000759414
SR-01000759414-6
ST2419391
Tox21_110717
Tox21_110717_1
Tox21_201506
Tox21_302744
UNII-57GNO57U7G
X-2990
YM-152
ZINC3782599

US Patents and Regulatory Information for FINASTERIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global FINASTERIDE finasteride TABLET;ORAL 090508-001 Jul 1, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hetero Labs Ltd Iii FINASTERIDE finasteride TABLET;ORAL 090060-001 Jul 1, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for FINASTERIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 ➤ Sign Up ➤ Sign Up
Merck PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ➤ Sign Up ➤ Sign Up
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Covington
Cerilliant
Harvard Business School
Dow
Daiichi Sankyo
Cipla
Healthtrust
Express Scripts

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