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Generated: December 10, 2018

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INTRAROSA Drug Profile

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Which patents cover Intrarosa, and what generic alternatives are available?

Intrarosa is a drug marketed by Amag Pharms Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.

Summary for INTRAROSA
Drug patent expirations by year for INTRAROSA
Generic Entry Opportunity Date for INTRAROSA
Generic Entry Date for INTRAROSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INSERT;VAGINAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for INTRAROSA
(+)-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
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
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 INTRAROSA

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Amag Pharms Inc INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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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