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PROSCAR Drug Profile

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When do Proscar patents expire, and what generic alternatives are available?

Proscar is a drug marketed by Merck and is included in one NDA.

The generic ingredient in PROSCAR is finasteride. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the finasteride profile page.

US ANDA Litigation and Generic Entry Outlook for Proscar

A generic version of PROSCAR was approved as finasteride by DR REDDYS LABS INC on July 28^th, 2006.

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Summary for PROSCAR

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	88
Clinical Trials:	13
Patent Applications:	5,893
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROSCAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROSCAR
DailyMed Link:	PROSCAR at DailyMed

Drug patent expirations by year for PROSCAR

Recent Clinical Trials for PROSCAR

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

Sponsor	Phase
Urologic Consultants of Southeastern PA	Phase 4
Merck Frosst Canada Ltd.	Phase 3
University Health Network, Toronto	Phase 3

See all PROSCAR clinical trials

Recent Litigation for PROSCAR

Identify potential future generic entrants

District Court Litigation

Case Name	Date
SmithKline Beecham Corporation d/b/a GlaxoSmithKline v. Barr Laboratories, Inc.	2008-02-25
Plaintiff(s) v. Defendant(s)	2008-01-31
Merck & Co. Inc. v. Dr. Reddy&039s Lab. Ltd	2004-09-29

See all PROSCAR litigation

Pharmacology for PROSCAR

Drug Class	5-alpha Reductase Inhibitor
Mechanism of Action	5-alpha Reductase Inhibitors

Synonyms for PROSCAR

(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,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
(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
17beta-(N-tert-butylcarbamoyl)-4-aza-5 alpha-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
ACT02599
AK-72879
AKOS015894916
Andozac
BCP0726000222
BCP9000685
BCPP000229
BDBM50334788
BPBio1_001027
BR-72879
BRD-K01095011-001-03-5
BRD-K01095011-001-15-9
BRN 4269024
BSPBio_000933
C-34893
C23H36N2O2
CAS-98319-26-7
CC-28426
CCG-100937
CCRIS 7438
CHEBI:5062
CHEMBL710
Chibro-Proscar
CPD000466304
CS-1767
D00321
DB01216
DBEPLOCGEIEOCV-WSBQPABSSA-N
DSSTox_CID_625
DSSTox_GSID_20625
DSSTox_RID_75699
DTXSID3020625
EX-A1951
Finasterida
Finasterida [INN-Spanish]
finasteride
Finasteride (JAN/USP/INN)
Finasteride (Proscar)
Finasteride [USAN:INN:BAN]
Finasteride [USAN:USP:INN:BAN]
Finasteride for peak identification, European Pharmacopoeia (EP) Reference Standard
Finasteride, >=98% (HPLC), powder
Finasteride, 98%
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
Finpecia
FT-0082891
GTPL6818
HMS1570O15
HMS2051F09
HMS2090G22
HMS2097O15
HMS2235L23
HMS3714O15
HSDB 6793
HY-13635
J10122
KS-1058
L-652,931
LS-7397
MFCD00869737
MK 0906
MK 906
MK-0906
MK-906
MK906
MLS000759404
MLS001165768
MLS001424046
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
Prestwick0_000717
Prestwick1_000717
Prestwick2_000717
Prestwick3_000717
Propecia
Propecia (TN)
Proscar (TN)
Prostide
Q424167
s1197
SC-12178
SCHEMBL5509
SMR000466304
SPBio_002854
SR-01000759414
SR-01000759414-4
SR-01000759414-6
ST2419391
Tox21_110717
Tox21_110717_1
Tox21_201506
Tox21_302744
UNII-57GNO57U7G
X-2990
YM-152
ZINC3782599

Paragraph IV (Patent) Challenges for PROSCAR

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROSCAR	TABLET;ORAL	finasteride	020180

US Patents and Regulatory Information for PROSCAR

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Glossary

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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	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 PROSCAR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	Start Trial	Start Trial
Merck	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	Start Trial	Start Trial
Merck	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	Start Trial	Start Trial
Merck	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	Start Trial	Start Trial
Merck	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PROSCAR

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Country	Patent Number	Estimated Expiration
Canada	2023158	Start Trial
Israel	107574	Start Trial
Bulgaria	61798	Start Trial
Latvia	12212	Start Trial
Iceland	1671	Start Trial
Slovakia	281765	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for PROSCAR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0155096	93C0055	Belgium	Start Trial	PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527
0155096	SPC/GB93/006	United Kingdom	Start Trial	SPC/GB93/006:, EXPIRES: 20070526
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description