Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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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 patent protection?

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 fifty-five patent family members in twenty-eight countries.

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

Summary for prasterone
International Patents:55
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Suppliers / Packagers: 1
Bulk Api Vendors: 82
Clinical Trials: 12
Patent Applications: 5,851
DailyMed Link:prasterone at DailyMed
Recent Clinical Trials for prasterone

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

SponsorPhase
Olivia Cardenas-Trowers, M.D.Phase 3
Center for Vulvovaginal DisordersPhase 3
AMAG Pharmaceuticals, Inc.Phase 3

See all prasterone clinical trials

Synonyms for prasterone
(+)-Dehydroisoandrosterone
(+)-Dehydroisoandrosterone, 99%
(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,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
(3alpha,8alpha)-3-hydroxyandrost-5-en-17-one
(3beta,16alpha)-3,16-dihydroxy-androst-5-en-17-one
(3beta)-3-hydroxy-Androst-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
3b-Hydroxy-D5-androsten-17-one
3b-Hydroxyandrost-5-en-17-one
3beta-hydroxy-5-androsten-17-one
3beta-hydroxy-androst-5-en-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-3.beta.-ol-17-one
5-Androsten-3B-ol-17-one
5-Androsten-3beta-ol-17-one
5-Androsten-3beta-ol-17-one; DHEA
5-dehydro-Epiandrosterone
5-Dehydroepiandrosterone
5,6-Dehydroisoandrosterone
5,6-Dehydroisoandrostorone
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-3b-ol-17-one
Androst-5-ene-3beta-ol-17-one
Androsten-3beta-ol-17-one
Androstenolone
Aslera
Astenile
BCP02453
BCP9000602
BCPE00002
BCPP000260
BDBM50223368
BIDD:PXR0080
Biolaif (TN)
bmse000665
BRD-K41256143-001-12-7
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
D08409
D5-Androsten-3b-ol-17-one
D5-Androsten-3beta-ol-17-one
DB01708
Deandros
Dehydro-epi-androsterone
dehydroepiandrostenedione
Dehydroepiandrosternoe
Dehydroepiandrosterone
dehydroepiandrosterone (dhea)
Dehydroepiandrosterone (DHEA) solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Dehydroisoandrosterone
Delta5-androsten-3-beta-ol-17-one
DHEA
DHEA (trans-Dehydroandrosterone)
DHEA; Prasterone
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 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
NCGC00093802-09
NCGC00256412-01
NCGC00259545-01
NCI60_042215
NSC 9896
NSC-9896
NSC9896
PB-007
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
SR-01000075815-4
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   Start Trial   Start Trial Y   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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