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Prasterone - Generic Drug Details

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What are the generic sources for prasterone and what is the scope of prasterone freedom to operate?

Prasterone is the generic ingredient in one branded drug marketed by Amag Pharms Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Prasterone has forty-eight patent family members in twenty-seven countries.

There are seven drug master file entries for prasterone. One supplier is listed for this compound.

Summary for prasterone

International Patents:	48
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Clinical Trials:	10
Patent Applications:	5,757
DailyMed Link:	prasterone at DailyMed

Synonyms for prasterone

(+)-Dehydroisoandrosterone

(1S,2R,5S,10R,11S,15S)-5-hydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-7-en-14-one

(1S,2R,5S,10R,11S,15S)-5-HYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-7-EN-14-ONE

(1S,5S,11S,15S,2R,10R)-5-hydroxy-2,15-dimethyltetracyclo[8.7.0.0<2,7>.0<11,15> ]heptadec-7-en-14-one

(3-beta)-3-Hydroxyandrost-5-en-17-one

(3beta)-3-hydroxyandrost-5-en-17-one

(3beta)-3-Hydroxyandrost-5-ene-17-one

(3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,10,11,12,13,14,15,16-tetradecahydro-17H-cyclopenta[a]phenanthren-17-one

(3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one

(3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-3,4,7,8,9,10,11,12,13,14,15,16-dodecahydro-1H-cyclopenta[a]phenanthren-17(2H)-one

105597-37-3

108673-53-6

17-Chetovis

17-Hormoforin

1A9D2040-240C-427D-ADE4-0CB700B785CB

3-|A-hydroxy-5-androsten-17-one

3-beta-hydroxy-5-androsten-17-on

3-beta-Hydroxy-5-androsten-17-one

3-beta-hydroxyandrost-5-en-17-one

3.beta.-Hydroxyandrost-5-en-17-one

3beta-hydroxy-5-androsten-17-one

3beta-Hydroxy-D5-androsten-17-one

3beta-hydroxyandrost-5-en-17-one

3beta-Hydroxyandrost-5-ene-17-one

3beta-Hyroxyandrost-5-en-17-one

4-08-00-00994 (Beilstein Handbook Reference)

459AG36T1B

5-Androsten-3.beta.-ol-17-one

5-Androsten-3beta-ol-17-one

5-Androsten-3beta-ol-17-one; DHEA

5-Dehydroepiandrosterone

5,6-Dehydroisoandrosterone

5,6-Dehydroisoandrostorone

5,6-didehydroepiandrosterone

5,6-Didehydroisoandrosterone

53-43-0

9013-35-8

AB0007943

AB00375810_09

AB00375810-06

AB1009532

AC-28716

AC1L1LC4

ACT02646

AJ-45664

AK125048

AKOS007930299

AKOS015951378

AN-24410

Anastar

AND

Andrestenol

Androst-5-en-17-one, 3-beta-hydroxy-

Androst-5-en-17-one, 3-hydroxy-, (3-beta)-

Androst-5-en-17-one, 3-hydroxy-, (3-beta)- (9CI)

Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-

Androst-5-en-17-one, 3-hydroxy-, (3b)-

Androst-5-en-17-one, 3-hydroxy-, (3beta)-

Androst-5-en-17-one, 3-hydroxy-, (3beta)- (9CI)

Androst-5-en-17-one, 3.beta.-hydroxy-

Androst-5-en-17-one, 3beta-hydroxy-

Androst-5-en-17-one, 3beta-hydroxy- (8CI)

Androst-5-ene-3beta-ol-17-one

Androstenolone

Aslera

Astenile

BCP9000602

BCPE00002

BCPP000260

BDBM50223368

BIDD:PXR0080

Biolaif (TN)

bmse000665

BRN 2058110

C-18147

C01227

CAS-53-43-0

Caswell No. 051F

CC-26313

CCG-101190

CCRIS 3277

CHEBI:28689

CHEMBL90593

CMC_13435

CS-1667

D 4000

D-0340

D0044

D00OAW

D08409

D0K0EK

D5-Androsten-3beta-ol-17-one

DB01708

Deandros

Dehydro-epi-androsterone

dehydroepiandrostenedione

Dehydroepiandrosternoe

Dehydroepiandrosterone

dehydroepiandrosterone (dhea)

Dehydroepiandrosterone, Neuroscience Pharma

Dehydroepiandrosterone, Paladin Labs

Dehydroisoandrosterone

Delta5-androsten-3-beta-ol-17-one

DHEA

DHEA (trans-Dehydroandrosterone)

DHEA, Neuroscience Pharma

DHEA, Paladin Labs

Diandron

Diandrone

DL-373

DSSTox_CID_379

DSSTox_GSID_20379

DSSTox_RID_75553

DTXSID4020379

EBD1328208

EC 200-175-5

EINECS 200-175-5

EL-10

EM-760

EPA Pesticide Chemical Code 126510

Epiandrosterone, 5-dehydro-

EU-0100368

Fidelin

Fidelin T

FMGSKLZLMKYGDP-USOAJAOKSA-N

GL 701

GL-701

GL701

GS-0906

GTPL2370

HMS2052P11

HMS2090C04

HMS2232K11

HY-14650

Hydroxyandrost-5-en-17-one

IM 28

Inflabloc

Intrarosa

IP-1001

IPL-1001

J10065

LMST02020021

Lopac0_000368

LS-7296

M-1336

MFCD00003613

MLS001066350

MLS001333231

MLS001333232

MLS001424274

MolPort-003-929-763

NC00440

NCGC00093802-04

NCGC00093802-06

NCGC00256412-01

NCGC00259545-01

NCI60_042215

NSC 9896

NSC-9896

NSC9896

PB-007

PL000184

Prasterona

Prasterona [INN-Spanish]

Prasterone (DHEA; Dehydroepiandrosterone)

Prasterone (DHEA; Dehydroepiandrosterone) 1.0 mg/ml in Acetonitrile

Prasterone (INN)

Prasterone [INN]

Prasterone [USAN:INN]

Prasteronum

Prasteronum [INN-Latin]

Prestara

Psicosterone

s2604

SBB012501

SCHEMBL24156

SH-K-04828

Siscelar plus

SMR000059075

SR-01000075815

SR-01000075815-1

ST069381

Tox21_111222

Tox21_111222_1

Tox21_201996

Tox21_302761

TR-018899

trans-de-hydroandrosterone

trans-Dehydroandrosterone

trans-Dehydroandrosterone, >=99%

UNII-459AG36T1B

Vaginorm

Z2213891300

ZINC3807917

US Patents and Regulatory Information for prasterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amag Pharms Inc	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes
Amag Pharms Inc	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y
Amag Pharms Inc	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes			Y
Amag Pharms Inc	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes

International Patents for prasterone

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	020683
European Patent Office	2441456
Canada	2820566
Singapore	183702
South Korea	20130103805
Mexico	2010001627