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Drug ReportsNorethisterone
Norethindrone
Activella, Alyacen, Amabelz, Aranelle, Aurovela, Balziva, Blisovi, Briellyn, Camila, Combipatch, Cyonanz, Dasetta, Emzahh, Errin, Estradiol / Norethindrone, Etyqa, Fe, Finzala, Fyavolv, Gemmily, Gildagia, Gildess, Hailey, Heather, Incassia, Jencycla, Junel, Larin, Leribane, Lupaneta Pack, Merzee, Mibelas, Nor-qd, Norethindrone, Norinyl, Norlestrin, Nortrel, Nylia, Ortho-novum, Oshih, Philith, Taytulla, Wera (norethindrone) is a small molecule pharmaceutical. Norethindrone was first approved as Norlestrin fe 1/50 on 1982-01-01. It is used to treat acne vulgaris, endometrial hyperplasia, endometriosis, hypogonadism, and menorrhagia in the USA. The pharmaceutical is active against progesterone receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
activellaNew Drug Application2023-11-30
affodelANDA2024-04-22
alyacen 1/35ANDA2024-05-07
alyacen 1/35 alyacen 7/7/7ANDA2017-09-08
alyacen 7/7/7ANDA2023-06-07
aranelleANDA2023-01-31
aurovela 1.5/30ANDA2023-11-21
aurovela 1/20ANDA2023-11-21
aurovela 24 feANDA2023-11-21
aurovela feANDA2023-11-21
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Indications
FDA
EMA
No data
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
Patent Expiration
Patent
Expires
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FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
110335512037-09-29U-3129
93468222024-02-17U-3129
73009352024-01-28DP
80582802024-01-28DP
Ethinyl Estradiol / Norethindrone Acetate, Lo Loestrin Fe, Apil
77049842029-02-02U-1, U-1090
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
— G03AA05: Norethisterone and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB04: Norethisterone and ethinylestradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC01: Norethisterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DC: Estren derivatives, sex hormones and modulators of the genital system
— G03DC02: Norethisterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA01: Norethisterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB05: Norethisterone and estrogen
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
No data
Clinical
Clinical Trials
173 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889HP_0000131D25—14—27
MyofibromaD047708———14—27
HemorrhageD006470MP_0001914R58—14—16
MenorrhagiaD008595EFO_0003945N92.0—14—16
EndometriosisD004715EFO_0001065N80——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine hemorrhageD014592———1———1
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNorethindrone
INNnorethisterone
Description
Norethisterone is a 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen. It has a role as a synthetic oral contraceptive and a progestin. It is a 17beta-hydroxy steroid, a terminal acetylenic compound, a tertiary alcohol and a 3-oxo-Delta(4) steroid. It derives from a hydride of an estrane.
Classification
Small molecule
Drug classProgestogen (medication); Progestin
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21C
Identifiers
PDB—
CAS-ID68-22-4
RxCUI—
ChEMBL IDCHEMBL1162
ChEBI ID7627
PubChem CID6230
DrugBankDB00717
UNII IDT18F433X4S (ChemIDplus, GSRS)
Target
Agency Approved
PGR
PGR
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
5241
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Q9UPF7
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Loestrin – Allergan
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Loestrin – Warner Chilcott
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Loestrin – AbbVie
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Myfembree – Myovant Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,158 documents
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Safety
Black-box Warning
Black-box warning for: Activella, Aurovela 1.5/30, Aurovela 24 fe, Blisovi 24 fe, Blisovi fe 1.5/30, Blisovi fe 1/20, Charlotte 24fe, Combipatch (estradiol/norethindrone acetate transdermal system), Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Dasetta 1/35, Dasetta 7/7/7, Estradiol / norethindrone acetate, Estradiol and norethindrone acetate, Etyqa, Femhrt, Femlyv, Finzala, Fyavolv, Gemmily, Hailey 1.5/30, Hailey 24 fe, Hailey fe 1.5/30, Hailey fe 1/20, Jinteli, Junel, Junel fe, Junel fe 1/20, Kaitlib fe, Larin 1.5/30, Larin 1/20, Larin 24 fe, Larin fe 1/20, Layolis fe, Lo loestrin fe, Loestrin, Loestrin 24 fe, Melodetta 24 fe, Merzee, Mibelas 24 fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin 24 fe, Microgestin fe 1/20, Mimvey, Mimvey mimvey lo, Myfembree, Necon, Nexesta fe, 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, Nylia 1/35, Nylia 7/7/7, Oriahnn, Oshih, Tarina 24 fe, Taysofy, Taytulla, Tilia fe, Tri-legest fe, Wera, Wymzya fe, Zenchent fe
Adverse Events
Top Adverse Reactions
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18,628 adverse events reported
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