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Drug ReportsEstradiol valerate
Estradiol valerate
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 valerate) is a small molecule pharmaceutical. Estradiol valerate 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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Events Timeline
5D
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3M
6M
YTD
1Y
2Y
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FDA approval date
EMA approval date
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Study 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
Delestrogen (discontinued: Delestrogen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol valerate
Tradename
Company
Number
Date
Products
DELESTROGENEndoN-009402 RX1982-01-01
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aloraOTC monograph not final2019-09-18
bijuvaNew Drug Application2025-01-28
climaraNew Drug Application2023-12-06
climara proNew Drug Application2023-12-06
climarapro2009-01-20
delestrogenNew Drug Application2024-07-08
divigelNew Drug Application2023-11-21
elestrinNew Drug Application2024-02-27
estraceANDA2024-08-12
estradiol valerateANDA2025-07-03
Show 12 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
hot flashes—D019584—
hypogonadism—D007006E23.0
premature menopause—D008594E28.31
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
117938122038-05-03U-2360
110335512037-09-29U-3129
117951782033-09-27DS, DP
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
117938192032-11-21U-2439
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
No data
HCPCS
Code
Description
J1380
Injection, estradiol valerate, up to 10 mg
Clinical
Clinical Trials
1904 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5—1——6
AtrophyD001284————2——2
ContraceptionD003267————1——1
DyspareuniaD004414—N94.1——1——1
VaginitisD014627EFO_0005757N76——1——1
Atrophic vaginitisD059268EFO_1001271———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemostasisD006487———2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEstradiol valerate
INNestradiol valerate
Description
Estradiol valerate is a steroid ester.
Classification
Small molecule
Drug classestrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCc4cc(O)ccc4[C@H]3CC[C@]12C
Identifiers
PDB—
CAS-ID979-32-8
RxCUI—
ChEMBL IDCHEMBL1511
ChEBI ID31561
PubChem CID13791
DrugBankDB13956
UNII IDOKG364O896 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Estradiol – Amneal Pharmaceuticals
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Divigel – RVL Pharmaceuticals
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Ryeqo – Myovant Sciences
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Imvexxy – TherapeuticsMD
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Bijuva – TherapeuticsMD
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Myfembree – Myovant Sciences
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,445 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Climara, Climara pro, Climarapro, Delestrogen, Divigel, Elestrin, Estrace, Estradiol valerate, Estradiol valerate and estradiol valerate/dienogest, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Natazia, Vagifem, Vivelle dot, Vivelle-dot
Adverse Events
Top Adverse Reactions
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30,626 adverse events reported
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