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Last Updated: December 6, 2019

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Estradiol valerate - Generic Drug Details

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

Estradiol valerate is the generic ingredient in four branded drugs marketed by Par Sterile Products, Am Regent, Dr Reddys, Fosun Pharma, Watson Labs, and Savage Labs, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-five drug master file entries for estradiol valerate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for estradiol valerate

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Recent Clinical Trials for estradiol valerate

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

SponsorPhase
CRG UZ BrusselPhase 3
University Hospital, GhentPhase 3
Mỹ Đức HospitalN/A

See all estradiol valerate clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG;2MG;3MGTABLET;ORAL
  Start Trial  Start Trial1MG;2MG;2MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for estradiol valerate
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Synonyms for estradiol valerate
(17.beta.)-Estra-1,3,5(10)-triene-3,17-diol 17-valerate
(17beta)-3-hydroxyestra-1(10),2,4-trien-17-yl pentanoate
(1S,11S,14S,15S,10R)-5-hydroxy-15-methyltetracyclo[8.7.0.0<2,7>.0<11,15>]hepta deca-2,4,6-trien-14-yl pentanoate
(1S,11S,14S,15S,10R)-5-hydroxy-15-methyltetracyclo[8.7.0.0<2,7>.0<11,15>]hepta deca-2(7),3,5-trien-14-yl pentanoate
(8R,9S,13S,14S,17S)-3-hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthren-17-yl pentanoate
[(8R,9S,13S,14S,17S)-13-methyl-3-oxidanyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] pentanoate
[(8R,9S,13S,14S,17S)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] pentanoate
1,3,5(10)-Estratriene-3,17beta-diol 17-pentanote
124683-EP2295426A1
124683-EP2295427A1
17-BETA-ESTRADIOL 17-VALERATE
17-pentanoyl-estra-1,3,5(10)-triene-3,17beta-diol
17|A-Estradiol-17-valerate
3-Hydroxy-17beta-valeroyloxyestra-1,3,5(10)-triene
69557-95-5
907-12-0
979-32-8
979E328
A845765
AB00382980_15
AB0106305
AC1L22HN
AKOS005267158
API0002610
ARONIS24416
Atladiol
B-Estradiol 17-valerate
B1506
BBC/580
BCP11918
beta-Estradiol 17-valerate
BRD-K66766661-001-19-2
C12859
CAS-979-32-8
CCG-221130
CCRIS 5571
CHEBI:31561
CHEMBL1511
Climaval
component of Deluteval 2X
component of Ditate
component of Mal-O-Fem L.A
CPD000058346
CS-2904
Cyclocur
D01413
Deladiol
Deladumone (TN)
Delahormone unimatic
Delestrogen
Delestrogen 4X
Depo estro med
Depo-Estro-Med
DSSTox_CID_3004
DSSTox_GSID_23004
DSSTox_RID_76827
DTXSID8023004
Dura-estradiol
Duratrad
E0876
EBD28143
EINECS 213-559-2
Estate
Estra-1,3,5(10)-triene-3,17-diol (17-beta)-, 17-pentanoate
Estra-1,3,5(10)-triene-3,17-diol (17.beta.)-, 17-pentanoate
Estra-1,3,5(10)-triene-3,17-diol(17beta)-, 17-pentanoate
Estra-1,5(10)-triene-3,17-diol (17.beta.)-, 17-pentanoate
Estradiol 17-valerate
Estradiol 17?-valerate
Estradiol 17.beta.-valerate
Estradiol 17beta-valerate
Estradiol Depot
Estradiol valerate (JAN/USP/INN)
Estradiol valerate (VAN)
Estradiol valerate [USAN:INN:JAN]
Estradiol valerate [USP:INN:BAN:JAN]
Estradiol valerianate
estradiol-17-valerate
Estradiol-17-valerate; 1,3,5(10)-Estratriene-3,17b-diol 17-pentanote
ESTRADIOL, 17-VALERATE
Estradioli valeras
Estradioli valeras [INN-Latin]
Estraval
Estraval 2X
Estraval PA
Estroval-10
Exten strone
Femogen-L.A
Femogen-L.A.
Femogex
GTPL7655
Gynogen L.A. 10
Gynogen L.A. 20
Gynogen L.A. 40
Gynogen L.A.10
Gynogen LA
Gynokadin
HMS2232L17
HMS3259C12
HMS3715B21
HY-B0672
KS-5213
LMST02010039
LS-64737
MCULE-6732064308
Merimono
MFCD00056541
MLS000028449
MLS001146931
MolPort-002-507-065
NC00560
NCGC00094673-01
Neofollin
NSC 17590
NSC-17590
NSC17590
Nuvelle
Oestradiol valerate
Oestradiol-17b-valerate
OKG364O896
Opera_ID_444
Pelanin
Pelanin depot
pentanoate d'estra-1,3,5(10)-tri ne-3-ol-17|A-yle
pentanoic acid [(8R,9S,13S,14S,17S)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] ester
Pharlon
Postoval
Primogyn-Depot
Primogyna
Progynon-Depot
Progynova
Q-201506
Repo-Estra
Ronfase
RSEPBGGWRJCQGY-RBRWEJTLSA-N
s3149
SBB080821
SCHEMBL40563
SMR000058346
SR-01000003061
SR-01000003061-3
ST075188
ST24046695
Tox21_111312
UNII-OKG364O896
Valerate d'estradiol
Valerate d'estradiol [INN-French]
Valerato de estradiol
Valerato de estradiol [INN-Spanish]
Valergen
ZINC3881556

US Patents and Regulatory Information for estradiol valerate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-001 Jan 19, 2010 AO RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-003 Approved Prior to Jan 1, 1982 AO RX Yes Yes   Start Trial   Start Trial   Start Trial
Watson Labs ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 083546-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Savage Labs DITATE-DS estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 086423-001 Approved Prior to Jan 1, 1982 DISCN No No   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

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