ETHYNODIOL
Ethinyl Estradiol / Ethynodiol, Kelnor, Lo-malmorede, Malmorede, Ovulen, Zovia (ethynodiol) is a small molecule pharmaceutical. Ethynodiol was first approved as Demulen 1/50-21 on 1982-01-01.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Ethynodiol ethinyl estradiol, Kelnor, Lo-malmorede, Malmorede, Zovia (discontinued: Demulen, Ovulen, Zovia)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
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Ethynodiol diacetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DEMULEN 1/50-21 | G.D. Searle | N-016927 DISCN | 1982-01-01 | 1 products |
| DEMULEN 1/50-28 | G.D. Searle | N-016936 DISCN | 1982-01-01 | 1 products |
| DEMULEN 1/35-28 | G.D. Searle | N-018160 DISCN | 1982-01-01 | 1 products |
| DEMULEN 1/35-21 | G.D. Searle | N-018168 DISCN | 1982-01-01 | 1 products |
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Ethynodiol diacetate
+
Mestranol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OVULEN | G.D. Searle | N-016029 DISCN | 1982-01-01 | 1 products |
| OVULEN-21 | G.D. Searle | N-016029 DISCN | 1982-01-01 | 1 products |
| OVULEN-28 | G.D. Searle | N-016705 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ethynodiol diacetate and ethinyl estradiol | ANDA | 2021-12-18 |
| kelnor 1/35 | ANDA | 2023-02-04 |
| kelnor 1/50 | ANDA | 2021-12-17 |
| zovia 1/35 | ANDA | 2024-06-01 |
| zovia 1/35e-28 zovia 1/50e-28 | ANDA | 2012-04-13 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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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
— G03AA01: Etynodiol and ethinylestradiol
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DC: Estren derivatives, sex hormones and modulators of the genital system
— G03DC06: Etynodiol
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA06: Etynodiol and estrogen
HCPCS
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Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ETHYNODIOL |
| INN | etynodiol |
| Description | Ethynodiol is a 17beta-hydroxy steroid, a 3beta-hydroxy steroid and a terminal acetylenic compound. It has a role as a progestin. |
| Classification | Small molecule |
| Drug class | Progestin; Progestogen |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=C[C@@H](O)CC[C@@H]4[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 1231-93-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201406 |
| ChEBI ID | 50785 |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 9E01C36A9S (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Ethynodiol
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 415 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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118 adverse events reported
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