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Drug ReportsEstradiol
Delestrogen, Zoely(estradiol)
Activella, Amabelz, Angeliq, Bijuva, Climara, Combipatch, Delestrogen, Depo-testadiol, Ditate, Divigel, Elestrin, Estrace, Estradiol, Estrasorb, Estring, Estrogel, Etyqa, Evamist, Femring, Imvexxy, Ioa, Lunelle, Menostar, Minivelle, Myfembree, Natazia, Prefest, Ryeqo, Vagifem, Vivelle-dot, Zoely (estradiol) is a small molecule pharmaceutical. Estradiol was first approved as Estrace on 1982-01-01. It is used to treat breast neoplasms, hot flashes, hypogonadism, menorrhagia, and premature menopause amongst others in the USA. It has been approved in Europe to treat contraception and leiomyoma.
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Drug
Target
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
therapeuticsD013812
reproductive and urinary physiological phenomenaD012101
Trade Name
FDA
EMA
Climara, Delestrogen, Depo-estradiol, Divigel, Elestrin, Estrace, Estradiol, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Vagifem, Vivelle-dot (discontinued: Alora, Delestrogen, Depo-estradiol, Esclim, Estrace, Estraderm, Estradiol, Estradiol cypionate, Estrasorb, Estrogel, Fempatch, Femtrace, Gynodiol, Innofem, Vagifem, Vivelle)
Combinations
Activella, Amabelz, Angeliq, Bijuva, Climara, Combipatch, Estradiol norethindrone, Myfembree, Natazia (discontinued: Activella, Depo-testadiol, Ditate, Estradiol norethindrone, Estradiol norgestimate, Estradiol progesterone, Etyqa, Lunelle, Prefest, Testosterone cypionate-estradiol cypionate, Testosterone enanthate estradiol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Progesterone
Tradename
Company
Number
Date
Products
BIJUVAMayne GroupN-210132 RX2018-10-28
2 products, RLD, RS
Estradiol
Tradename
Company
Number
Date
Products
ESTROGELAscend TherapeuticsN-021166 RX2004-02-09
1 products, RLD, RS
CLIMARABayerN-020375 RX1994-12-22
6 products, RLD, RS
MENOSTARBayerN-021674 RX2004-06-08
1 products, RLD, RS
IMVEXXYMayne GroupN-208564 RX2018-05-29
2 products, RLD, RS
ELESTRINMylanN-021813 RX2006-12-15
1 products, RLD, RS
MINIVELLENoven PharmaceuticalsN-203752 RX2012-10-29
5 products, RLD, RS
VAGIFEMNovo NordiskN-020908 RX2009-11-25
1 products, RLD, RS
EVAMISTPadagisN-022014 RX2007-07-27
1 products, RLD, RS
ESTRINGPfizerN-020472 RX1996-04-26
1 products, RLD, RS
VIVELLE-DOTSandozN-020538 RX1999-01-08
5 products, RLD, RS
Show 1 marketed
Show 8 discontinued
Estradiol
+
Levonorgestrel
Tradename
Company
Number
Date
Products
CLIMARA PROBayerN-021258 RX2003-11-21
1 products, RLD, RS
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ACTIVELLAAmneal PharmaceuticalsN-020907 RX1998-11-18
1 products, RLD, RS
COMBIPATCHNoven PharmaceuticalsN-020870 RX1998-08-07
2 products, RLD, RS
Show 1 discontinued
Estradiol valerate
Tradename
Company
Number
Date
Products
DELESTROGENEndoN-009402 RX1982-01-01
2 products, RLD, RS
Show 1 discontinued
Estradiol acetate
Tradename
Company
Number
Date
Products
FEMRINGMillicent PharmaN-021367 RX2003-03-20
2 products, RLD, RS
Show 1 discontinued
Drospirenone
+
Estradiol
Tradename
Company
Number
Date
Products
ANGELIQBayerN-021355 RX2005-09-28
2 products, RLD, RS
Estradiol
+
Norethindrone acetate
+
Relugolix
Tradename
Company
Number
Date
Products
MYFEMBREEMyovant SciencesN-214846 RX2021-05-26
1 products, RLD, RS
Dienogest
+
Estradiol valerate
Tradename
Company
Number
Date
Products
NATAZIABayerN-022252 RX2010-05-06
1 products, RLD, RS
Estradiol
+
Norgestimate
Tradename
Company
Number
Date
Products
PREFESTTevaN-021040 DISCN1999-10-22
1 products, RLD
Hide discontinued
Estradiol hemihydrate
Tradename
Company
Number
Date
Products
ESTRASORBExeltisN-021371 DISCN2003-10-09
1 products, RLD
Hide discontinued
Estradiol cypionate
+
Testosterone cypionate
Tradename
Company
Number
Date
Products
DEPO-TESTADIOLPharmacia & UpjohnN-017968 DISCN1982-01-01
1 products
Hide discontinued
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename
Company
Number
Date
Products
LUNELLEPharmacia & UpjohnN-020874 DISCN2000-10-05
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
activellaNew Drug Application2023-11-30
afia foaming e2 sanitizing hand cleanerOTC monograph not final2017-01-18
afirmelleANDA2024-09-19
aloraOTC monograph not final2019-09-18
alpet e2 sanitizing foamC2002632024-12-05
alpet e2 sanitizing foam soapOTC monograph not final2010-03-05
alpet q e2C2002632024-12-05
altaveraANDA2023-03-02
alyacen 1/35ANDA2024-05-07
alyacen 1/35 alyacen 7/7/7ANDA2017-09-08
Show 312 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
uterine hemorrhage—D014592—
primary ovarian insufficiencyEFO_0004266D016649E28.3
amenorrhea—D000568N91.2
endometrial hyperplasia—D004714N85.0
female infertilityEFO_0008560D007247N97
hot flashes—D019584—
hypogonadism—D007006E23.0
Show 7 more
Agency Specific
FDA
EMA
Expiration
Code
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES
2026-01-27M-289
2025-12-18NCE
2025-08-05I-898
2024-05-26NP
ESTRADIOL, ESTRADIOL, CHEMO RESEARCH SL
2023-04-08CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
110335512037-09-29U-3129
93468222024-02-17U-3129
73009352024-01-28DP
80582802024-01-28DP
Estradiol, Imvexxy, Mayne Pharma
112666612034-02-02U-2316, U-2317
91800912033-12-20DPU-2316, U-2317
102586302033-12-20U-2316, U-2317
103987082033-12-20U-2317, U-2614
104710722033-06-18U-2316, U-2317
105688912033-06-18U-2316, U-2317
106680822033-06-18U-2316, U-2317
108885162033-06-18U-2316, U-2317
110651972033-06-18DP
111167172033-06-18DP
111232832033-06-18DP
92893822032-11-21DP
105375812032-11-21DPU-2316, U-2317
108066972032-11-21DP
108354872032-11-21U-2316, U-2317
112414452032-11-21U-2316, U-2317
112468752032-11-21U-2316, U-2317
113049592032-11-21DP
113511822032-11-21U-2316, U-2317
114977092032-11-21U-2316, U-2317
Estradiol / Progesterone, Bijuva, Mayne Pharma
86331782032-11-21DP
88466482032-11-21U-2439
88466492032-11-21DPU-2439
89330592032-11-21DPU-2439
89872372032-11-21DP
89935482032-11-21DP
89935492032-11-21DP
90062222032-11-21DPU-2439
91141452032-11-21U-2439
91141462032-11-21DPU-2439
93019202032-11-21DPU-2439
100523862032-11-21DP
102069322032-11-21U-2439
106393752032-11-21DP
106752882032-11-21U-2439
108067402032-11-21DPU-2439
110336262032-11-21DPU-2439
111035132032-11-21U-2439
111035162032-11-21DP
111100992032-11-21DP
111669632032-11-21DP
115293602032-11-21DP
Drospirenone / Estradiol, Angeliq, Bayer Hlthcare
89068902031-10-22DP
Estradiol, Minivelle, Noven
82319062030-07-04DS, DP
97243102028-07-10DS, DP
97309002028-07-10U-2086
98334192028-07-10DP
Dienogest / Estradiol Valerate, Natazia, Bayer Hlthcare
81536162028-01-30U-1240
80715772026-05-13DPU-1
Estradiol Acetate, Femtrace, Apil
75727792025-10-02U-904
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA14: Nomegestrol and estradiol
— G03AA17: Medroxyprogesterone and estradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB08: Dienogest and estradiol
— G03C: Estrogens, sex hormones and modulators of the genital system
— G03CA: Natural and semisynthetic estrogens, plain
— G03CA03: Estradiol
— G03CA53: Estradiol, combinations
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CC: Anti-gonadotropin-releasing hormones
— H01CC54: Relugolix, estradiol and norethisterone
HCPCS
Code
Description
A9591
Fluoroestradiol f 18, diagnostic, 1 millicurie
J1000
Injection, depo-estradiol cypionate, up to 5 mg
J1380
Injection, estradiol valerate, up to 10 mg
J7294
Segesterone acetate and ethinyl estradiol 0.15mg, 0.013mg per 24 hours; yearly vaginal system, each
J7295
Ethinyl estradiol and etonogestrel 0.015mg, 0.12mg per 24 hours; monthly vaginal ring, each
Clinical
Clinical Trials
1730 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AtrophyD001284—————1—1
PostmenopauseD017698—————1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEstradiol
INNestradiol valerate
Description
17beta-estradiol is the 17beta-isomer of estradiol. It has a role as an estrogen, a human metabolite, an EC 1.2.3.1 (aldehyde oxidase) inhibitor, a Daphnia magna metabolite, a mouse metabolite and a geroprotector. It is a 17beta-hydroxy steroid and an estradiol.
Classification
Small molecule
Drug classestrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@@H]3c4ccc(O)cc4CC[C@H]3[C@@H]1CC[C@@H]2O
Identifiers
PDB—
CAS-ID50-28-2
RxCUI—
ChEMBL IDCHEMBL135
ChEBI ID16469
PubChem CID5757
DrugBankDB00783
UNII ID4TI98Z838E (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Estradiol – Amneal Pharmaceuticals
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Imvexxy – TherapeuticsMD
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Myfembree – Myovant Sciences
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Bijuva – TherapeuticsMD
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Ryeqo – Myovant Sciences
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Divigel – RVL Pharmaceuticals
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Estimated US medical usage
Estradiol
+
Dienogest
Total medical expenditures per year (USD, in millions)
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Estradiol
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Drospirenone
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Estradiol
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Estradiol
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Levonorgestrel
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Estradiol
+
Medroxyprogesterone
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Estradiol
+
Norethindrone
Total medical expenditures per year (USD, in millions)
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Estradiol
+
Norgestimate
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Estradiol
+
Testosterone
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Activella, Altavera, Amethia, Angeliq, Annovera, Ashlyna, Aurovela 1.5/30, Aurovela 24 fe, Ayuna, Azurette, Balcoltra, Bekyree, Beyaz, Bijuva, Blisovi 24 fe, Blisovi fe 1.5/30, Blisovi fe 1/20, Camrese, Camrese lo, Camreselo, Charlotte 24fe, Chateal eq, Climara, Climara pro, Climarapro, Combipatch (estradiol/norethindrone acetate transdermal system), Cryselle, Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Cyred eq, Dasetta 1/35, Dasetta 7/7/7, Daysee, Delestrogen, Depo-estradiol, Desogestrel and ethinyl estradiol, Divigel, Dotti, Drospirenone and ethinyl estradiol, Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Elestrin, Elinest, Eluryng, Enilloring, Enskyce, Estarylla, Estra-25 estra-50, Estrace, Estradiol, Estradiol / norethindrone acetate, Estradiol and norethindrone acetate, Estradiol and progesterone, Estradiol transdermal system, Estradiol vaginal, Estradiol vaginal cream, Estradiol vaginal inserts, Estradiol valerate, Estradiol valerate and estradiol valerate/dienogest, Estring, Estrogel, Etonogestrel and ethinyl estradiol, Etonogestrel and ethinyl estradiol vaginal, Etonogestrel and ethinyl estradiol vaginal ring, Etonogestrel/ethinyl estradiol, Etyqa, Evamist, Feirza 1.5/30 tm, Femhrt, Femlyv, Femring, Femynor, Finzala, Fyavolv, Galbriela, Gemmily, Hailey 1.5/30, Hailey 24 fe, Hailey fe 1.5/30, Hailey fe 1/20, Haloette, Iclevia, Imvexxy, Introvale, Isibloom, Jaimiess, Jasmiel, Jinteli, Jolessa, Joyeaux, Juleber, Junel, Junel fe, Junel fe 1/20, Kaitlib fe, Kalliga, Kariva, Kurvelo, Larin 1.5/30, Larin 1/20, Larin 24 fe, Larin fe 1/20, Layolis fe, Levonorgestrel and ethinyl estradiol, Levonorgestrel and ethinyl estradiol and ethinyl estradiol, Levonorgestrel/ethinyl estradiol and ethinyl estradiol, Levora, Lo loestrin fe, Lo simpesse, Lo-zumandimine, Loestrin, Loestrin 24 fe, Lojaimiess, Lopreeza, Loryna, Loseasonique, Low-ogestrel, Lyllana, Marlissa, Melodetta 24 fe, Menostar, Merzee, Mibelas 24 fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin 24 fe, Microgestin fe 1/20, Mili, Mimvey, Mimvey mimvey lo, Minivelle, Minzoya, Mono-linyah, Mononessa, Myfembree, Myzilra, Natazia, Necon, Nexesta fe, Nikki, Norelgestromin and ethinly estradiol, Norelgestromin and ethinyl estradiol, Norethindrone acetate and ethinyl estradiol, Norethindrone acetate and ethinyl estradiol and ferrous fumarate, Norethindrone acetate and ethinyl estradiol, and ferrous fumarate, Norethindrone and ethinyl estradiol, Norethindrone and ethinyl estradiol and ferrous fumarate, Norgestimate and ethinyl estradiol, Nuvaring, Nylia 1/35, Nylia 7/7/7, Nymyo, Ocella, Oriahnn, Ortho tri-cyclen lo, Oshih, Portia, Previfem, Quartette, Rivelsa, Safyral, Seasonique, Setlakin, Simliya, Simpesse, Sprintec, Syeda, Tarina 24 fe, Taysofy, Taytulla, Tilia fe, Tri femynor, Tri-estarylla, Tri-legest fe, Tri-linyah, Tri-lo- estarylla, Tri-lo-marzia, Tri-lo-mili, Tri-lo-sprintec, Tri-mili, Tri-nymyo, Tri-sprintec, Tri-vylibra, Tri-vylibra lo, Trinessa, Turqoz, Twirla, Tyblume, Tydemy, Vagifem, Vestura, Viorele, Vivelle dot, Vivelle-dot, Vylibra, Wera, Wymzya fe, Xarah fe, Xelria fe, Xulane, Yasmin, Yaz, Yuvafem, Zafemy, Zarah, Zenchent fe, Zumandimine
Adverse Events
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105,128 adverse events reported
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