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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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| activella | New Drug Application | 2023-11-30 |
| afirmelle | ANDA | 2024-09-19 |
| alora | OTC monograph not final | 2019-09-18 |
| altavera | ANDA | 2023-03-02 |
| alyacen 1/35 | ANDA | 2024-05-07 |
| alyacen 1/35 alyacen 7/7/7 | ANDA | 2017-09-08 |
| alyacen 7/7/7 | ANDA | 2023-06-07 |
| amethia | ANDA | 2024-03-01 |
| amethyst | ANDA | 2022-01-31 |
| angeliq | New Drug Application | 2023-12-08 |
Show 269 more
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES | |||
| 2026-01-27 | M-289 | ||
| 2025-12-18 | NCE | ||
| 2025-08-05 | I-898 | ||
| 2024-05-26 | NP | ||
ESTRADIOL, ESTRADIOL, CHEMO RESEARCH SL | |||
| 2023-04-08 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences | |||
| 11793812 | 2038-05-03 | U-2360 | |
| 11033551 | 2037-09-29 | U-3129 | |
| 11795178 | 2033-09-27 | DS, DP | |
| 9346822 | 2024-02-17 | U-3129 | |
| 7300935 | 2024-01-28 | DP | |
| 8058280 | 2024-01-28 | DP | |
| Estradiol, Imvexxy, Mayne Pharma | |||
| 11266661 | 2034-02-02 | U-2316, U-2317 | |
| 9180091 | 2033-12-20 | DP | U-2316, U-2317 |
| 10258630 | 2033-12-20 | U-2316, U-2317 | |
| 10398708 | 2033-12-20 | U-2317, U-2614 | |
| 10471072 | 2033-06-18 | U-2316, U-2317 | |
| 10568891 | 2033-06-18 | U-2316, U-2317 | |
| 10668082 | 2033-06-18 | U-2316, U-2317 | |
| 10888516 | 2033-06-18 | U-2316, U-2317 | |
| 11065197 | 2033-06-18 | DP | |
| 11116717 | 2033-06-18 | DP | |
| 11123283 | 2033-06-18 | DP | |
| 9289382 | 2032-11-21 | DP | |
| 10537581 | 2032-11-21 | DP | U-2316, U-2317 |
| 10806697 | 2032-11-21 | DP | |
| 10835487 | 2032-11-21 | U-2316, U-2317 | |
| 11241445 | 2032-11-21 | U-2316, U-2317 | |
| 11246875 | 2032-11-21 | U-2316, U-2317 | |
| 11304959 | 2032-11-21 | DP | |
| 11351182 | 2032-11-21 | U-2316, U-2317 | |
| 11497709 | 2032-11-21 | U-2316, U-2317 | |
| Estradiol / Progesterone, Bijuva, Mayne Pharma | |||
| 8633178 | 2032-11-21 | DP | |
| 8846648 | 2032-11-21 | U-2439 | |
| 8846649 | 2032-11-21 | DP | U-2439 |
| 8933059 | 2032-11-21 | DP | U-2439 |
| 8987237 | 2032-11-21 | DP | |
| 8993548 | 2032-11-21 | DP | |
| 8993549 | 2032-11-21 | DP | |
| 9006222 | 2032-11-21 | DP | U-2439 |
| 9114145 | 2032-11-21 | U-2439 | |
| 9114146 | 2032-11-21 | DP | U-2439 |
| 9301920 | 2032-11-21 | DP | U-2439 |
| 10052386 | 2032-11-21 | DP | |
| 10206932 | 2032-11-21 | U-2439 | |
| 10639375 | 2032-11-21 | DP | |
| 10675288 | 2032-11-21 | U-2439 | |
| 10806740 | 2032-11-21 | DP | U-2439 |
| 11033626 | 2032-11-21 | DP | U-2439 |
| 11103513 | 2032-11-21 | U-2439 | |
| 11103516 | 2032-11-21 | DP | |
| 11110099 | 2032-11-21 | DP | |
| 11166963 | 2032-11-21 | DP | |
| 11529360 | 2032-11-21 | DP | |
| 11793819 | 2032-11-21 | U-2439 | |
| Drospirenone / Estradiol, Angeliq, Bayer Hlthcare | |||
| 8906890 | 2031-10-22 | DP | |
| Estradiol, Minivelle, Noven | |||
| 8231906 | 2030-07-04 | DS, DP | |
| 9724310 | 2028-07-10 | DS, DP | |
| 9730900 | 2028-07-10 | U-2086 | |
| 9833419 | 2028-07-10 | DP | |
| Dienogest / Estradiol Valerate, Natazia, Bayer Hlthcare | |||
| 8153616 | 2028-01-30 | U-1240 | |
| 8071577 | 2026-05-13 | DP | U-1 |
| Estradiol Acetate, Femtrace, Apil | |||
| 7572779 | 2025-10-02 | U-904 | |
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1380 | Injection, estradiol valerate, up to 10 mg |
Clinical
Clinical Trials
1445 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | 14 | 15 | 15 | 34 | 70 | 143 |
| Contraception | D003267 | — | — | 21 | 19 | 49 | 20 | 31 | 137 |
| Healthy volunteers/patients | — | — | — | 112 | 7 | 7 | 6 | 4 | 132 |
| Menopause | D008593 | EFO_0003922 | N95 | 12 | 11 | 16 | 23 | 18 | 76 |
| Syndrome | D013577 | — | — | 7 | 10 | 16 | 16 | 22 | 71 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 6 | 2 | 8 | 15 | 23 | 54 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 25 | 6 | 2 | 15 | 51 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | 10 | 17 | 11 | 8 | 44 |
| Female infertility | D007247 | EFO_0008560 | N97 | 8 | 3 | 5 | 6 | 21 | 41 |
| Atrophy | D001284 | — | — | 4 | 7 | 18 | 6 | 4 | 38 |
Show 194 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofibroma | D047708 | — | — | — | 2 | 11 | — | 3 | 16 |
| Neoplasms | D009369 | — | C80 | 5 | 3 | 1 | — | 2 | 10 |
| Anorexia | D000855 | HP_0002039 | R63.0 | 2 | 6 | 3 | — | — | 9 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 2 | 6 | 3 | — | — | 9 |
| Inflammation | D007249 | MP_0001845 | — | — | 3 | 2 | — | 3 | 8 |
| Prostatic neoplasms | D011471 | — | C61 | — | 7 | 2 | — | — | 8 |
| Pituitary diseases | D010900 | — | E23.7 | — | 1 | 3 | — | 5 | 8 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 3 | 2 | — | — | 6 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | 1 | — | 4 | 5 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 4 | — | 1 | — | — | 5 |
Show 73 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tissue adhesions | D000267 | — | — | 3 | 1 | — | — | 11 | 14 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 9 | 1 | — | — | — | 9 |
| Covid-19 | D000086382 | — | — | — | 4 | — | — | 4 | 8 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 7 | 1 | — | — | — | 7 |
| Male breast neoplasms | D018567 | — | — | 1 | 2 | — | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Vulvodynia | D056650 | — | N94.81 | — | 1 | — | — | 2 | 3 |
| Gender identity | D005783 | — | — | 1 | 1 | — | — | 1 | 2 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | 1 | — | — | 1 | 2 |
| Hemostasis | D006487 | — | — | — | 2 | — | — | — | 2 |
Show 44 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 13 | — | — | — | 1 | 14 |
| Therapeutic equivalency | D013810 | — | — | 11 | — | — | — | 1 | 12 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | — | — | — | 6 | 8 |
| Hepatitis c | D006526 | — | B19.2 | 7 | — | — | — | — | 7 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 4 | — | — | — | 2 | 6 |
| Drug interactions | D004347 | — | — | 5 | — | — | — | 1 | 6 |
| Transgenes | D019076 | — | — | 1 | — | — | — | 2 | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | — | — | — | — | 3 |
| Pregnancy complications | D011248 | — | — | 1 | — | — | — | 2 | 3 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 1 | — | — | — | 1 | 2 |
Show 58 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 4 | 4 |
| Thromboembolism | D013923 | HP_0001907 | — | — | — | — | — | 4 | 4 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 3 | 3 |
| Menstrual cycle | D008597 | — | — | — | — | — | — | 3 | 3 |
| Cerebrospinal fluid leak | D065634 | — | G96.0 | — | — | — | — | 3 | 3 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | — | — | — | — | 2 | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | — | — | 2 | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 2 | 2 |
| Vascular stiffness | D059289 | — | — | — | — | — | — | 2 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 2 | 2 |
Show 120 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Estradiol valerate |
| INN | estradiol valerate |
| Description | Estradiol valerate is a steroid ester. |
| Classification | Small molecule |
| Drug class | estrogens |
| Image (chem structure or protein) |  |
| 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-ID | 979-32-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1511 |
| ChEBI ID | 31561 |
| PubChem CID | 13791 |
| DrugBank | DB13956 |
| UNII ID | OKG364O896 (ChemIDplus, GSRS) |
Target
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Divigel – RVL Pharmaceuticals
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Bijuva – TherapeuticsMD
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Estradiol – Amneal Pharmaceuticals
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Imvexxy – TherapeuticsMD
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Myfembree – Myovant Sciences
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Ryeqo – Myovant Sciences
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Estimated US medical usage
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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, Emoquette, 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, Femhrt, Femlyv, Femring, Femynor, Finzala, Fyavolv, 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, Mono-linyah, Mononessa, Myfembree, Myzilra, Natazia, Necon, Nexesta fe, Nikki, Norelgestromin and ethinly 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, Xulane, Yasmin, Yaz, Yuvafem, Zafemy, Zarah, Zenchent fe, Zumandimine
Adverse Events
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102,317 adverse events reported
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