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PROSCAR Drug Profile

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When do Proscar patents expire, and when can generic versions of Proscar launch?

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-six suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for PROSCAR

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	87
Clinical Trials:	13
Patent Applications:	5,894
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

See drug prices 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

AC1L1MUF

AC1Q5L2C

ACT02599

AJ-45596

AK-72879

AKOS015894916

AN-615

Andozac

BC200264

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

MolPort-002-500-272

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

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

US Patents and Regulatory Information for PROSCAR

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

Expired US Patents for PROSCAR

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