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Drug ReportsNorethindrone
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
Camila, Emzahh, Errin, Heather, Incassia, Jencycla, Nor-qd, Norethindrone (discontinued: Aygestin, Micronor, Norethindrone, Norlutate, Norlutin)
Combinations
Activella, Alyacen, Amabelz, Aranelle, Aurovela, Balziva, Blisovi, Briellyn, Chabelina fe, Combipatch, Cyonanz, Dasetta, Estradiol norethindrone, Femlyv, Finzala, Fyavolv, Gemmily, Gildagia, Gildess, Hailey, Junel, Kaitlib fe, Larin, Leribane, Lo loestrin fe, Merzee, Mibelas, Myfembree, Nexesta fe, Norethindrone ethinyl estradiol, Norethindrone ethinyl estradiol (), Norethindrone ethinyl estradiol ferrous, Nortrel, Nylia, Philith, Taytulla, Tri-legest fe, Tri-norinyl, Vyfemla, Wera (discontinued: Activella, Balziva, Brevicon, Cyclafem, Estradiol norethindrone, Estrostep fe, Etyqa, Femcon fe, Femhrt, Gencept, Gildess, Lo minastrin fe, Loestrin, Loestrin 21, Lupaneta pack, Microgestin, Minastrin, Modicon, Norcept, Norethin, Norethindrone ethinyl estradiol, Norethindrone ethinyl estradiol (), Norethindrone ethinyl estradiol ethinyl estradiol ferrous, Norethindrone ethinyl estradiol ferrous, Norethindrone mestranol, Norinyl, Norinyl 1+35, Norinyl 1+50, Norinyl 1+80, Norlestrin, Norlestrin 21, Norquest fe, Nortrel, Ortho-novum, Oshih, Ovcon, Pirmella, Rhuzdah, Tri-legest, Tri-norinyl)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
LO LOESTRIN FEAllerganN-022501 RX2010-10-21
1 products, RLD, RS
TAYTULLAAllerganN-204426 RX2013-04-19
1 products, RLD, RS
FEMLYVMillicent PharmaN-218718 RX2024-07-22
1 products, RLD, RS
Show 13 discontinued
Norethindrone
Tradename
Company
Number
Date
Products
NOR-QDTevaN-017060 RX1982-01-01
1 products, RLD, RS
Show 2 discontinued
Ethinyl estradiol
+
Norethindrone
Tradename
Company
Number
Date
Products
TRI-NORINYL 28-DAYDr Reddys LaboratoriesN-018977 RX1984-04-13
1 products, RLD, RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETevaN-022573 RX2010-12-22
1 products, RLD, RS
Show 20 discontinued
Mestranol
+
Norethindrone
Tradename
Company
Number
Date
Products
NORINYL 1+50 21-DAYAllerganN-013625 DISCN1982-01-01
1 products
NORINYLAllerganN-013625 DISCN1982-01-01
1 products
NORINYL 1+50 28-DAYAllerganN-016659 DISCN1982-01-01
1 products, RLD
NORINYL 1+80 21-DAYG.D. SearleN-016724 DISCN1982-01-01
1 products
NORINYL 1+80 28-DAYG.D. SearleN-016725 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/50 28Johnson & JohnsonN-016709 DISCN1982-01-01
1 products
ORTHO-NOVUM 10-21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/50 21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 2-21Johnson & JohnsonN-012728 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/80 21Johnson & JohnsonN-016715 DISCN1982-01-01
1 products
ORTHO-NOVUM 1/80 28Johnson & JohnsonN-016715 DISCN1982-01-01
1 products
Hide discontinued
Leuprolide acetate
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
LUPANETA PACKAbbVieN-203696 DISCN2012-12-14
2 products, RLD
Hide discontinued
Ethinyl estradiol
+
Ferrous fumarate
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
NORLESTRIN FE 1/50PfizerN-016766 DISCN1982-01-01
1 products
NORLESTRIN FE 2.5/50PfizerN-016854 DISCN1982-01-01
1 products
Hide discontinued
Norethindrone acetate
Tradename
Company
Number
Date
Products
AYGESTINDuramed PharmaceuticalsN-018405 DISCN1982-04-21
1 products, RLD
NORLUTATEPfizerN-012184 DISCN1982-01-01
1 products
Hide discontinued
Ethinyl estradiol
+
Ferrous fumarate
+
Norethindrone
Tradename
Company
Number
Date
Products
NORQUEST FEPfizerN-018926 DISCN1986-07-18
1 products
Hide discontinued
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
+
Norethindrone acetate
+
Relugolix
Tradename
Company
Number
Date
Products
MYFEMBREEMyovant SciencesN-214846 RX2021-05-26
1 products, RLD, RS
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
Show 110 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
acne vulgarisEFO_0003894D000152L70
endometriosisEFO_0001065D004715N80
primary ovarian insufficiencyEFO_0004266D016649E28.3
endometrial hyperplasia—D004714N85.0
hot flashes—D019584—
hypogonadismHP_0000044D007006E23.0
premature menopauseHP_0008209D008594E28.31
Show 6 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
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
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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———17—21121
EndometriosisD004715EFO_0001065N80—4131220
HemorrhageD006470MP_0001914R58—2103520
LeiomyomaD007889HP_0000131D25—2131420
MenorrhagiaD008595EFO_0003945N92.0—292619
ContraceptionD003267——1154516
MenopauseD008593EFO_0003922N952—1429
DysmenorrheaD004412HP_0100607N94.6——6118
Pelvic painD017699———12227
Uterine hemorrhageD014592———21227
Show 27 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyofibromaD047708———211—417
Contraception behaviorD003268——1—1—24
ArthritisD001168HP_0001369M05-M142—1——3
Systemic lupus erythematosusD008180HP_0002725M321—1—13
PostmenopauseD017698———11——2
Rheumatoid arthritisD001172EFO_0000685M06.91—1——2
Breast neoplasmsD001943EFO_0003869C50——1—12
LymphomaD008223—C85.9—11——1
Fertility preservationD059247———11——1
OvulationD010060————1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2031——15
Benign familial pemphigusD016506—Q82.811——35
PregnancyD011247EFO_0002950Z33.111——13
Endometrial hyperplasiaD004714—N85.0—2——13
HyperplasiaD006965EFO_0000536——2——13
Polycystic ovary syndromeD011085EFO_0000660E28.211———2
SyndromeD013577———1——12
HyperandrogenismD017588———2———2
Non-small-cell lung carcinomaD002289———1———1
Lung neoplasmsD008175HP_0100526C34.90—1———1
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B202———13
Pregnancy rateD018873——1———23
PharmacokineticsD010599——2————2
Hepatitis cD006526—B19.22————2
NeoplasmsD009369—C802————2
Type 2 diabetes mellitusD003924EFO_0001360E112————2
Darier diseaseD007644Orphanet_218E50.81———12
Bacterial infectionsD001424—A491————1
HepatitisD006505HP_0012115K75.91————1
HepacivirusD016174——1————1
Show 15 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood coagulation disordersD001778EFO_0009314D68.9————22
Hemostatic disordersD020141——————22
HeadacheD006261HP_0002315R51————22
Pregnancy complicationsD011248——————22
High-risk pregnancyD018566——————22
Pituitary diseasesD010900—E23.7————11
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——————11
MicrobiotaD064307——————11
Venous thromboembolismD054556EFO_0004286I74————11
Pulmonary embolismD011655HP_0002204I26————11
Show 24 more
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
$
€
£
â‚£
Myfembree – Myovant Sciences
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Loestrin – Allergan
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Loestrin – Warner Chilcott
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Loestrin – AbbVie
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Tabular view
Estimated US medical usage
Norethindrone
+
Estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Norethindrone
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Norethindrone
+
Mestranol
Total medical expenditures per year (USD, in millions)
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Norethindrone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 20,622 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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17,881 adverse events reported
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