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Drug ReportsNorethindrone
Loestrin fe 1/20, Ryeqo(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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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, Oriahnn, 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
Show 21 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
Elagolix sodium
+
Elagolix sodium
+
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ORIAHNN (COPACKAGED)AbbVieN-213388 RX2020-05-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
affodelANDA2024-04-22
camilaANDA2024-04-01
deblitaneANDA2024-07-10
emzahhANDA2023-04-10
errinANDA2024-03-01
gallifreyANDA2024-10-31
heatherANDA2021-08-31
incassiaANDA2021-09-14
jencyclaANDA2025-05-19
junel feANDA2025-01-17
Show 11 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
167 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R582103621
Healthy volunteers/patients1721121
LeiomyomaD007889D252131521
EndometriosisD004715EFO_0001065N804131220
MenorrhagiaD008595EFO_0003945N92.0292619
ContraceptionD0032671154415
MenopauseD008593EFO_0003922N9521429
Uterine hemorrhageD01459221238
DysmenorrheaD004412N94.66118
Pelvic painD01769912227
Show 26 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyofibromaD047708211518
ArthritisD001168EFO_0005856M05-M14213
Contraception behaviorD0032681113
Systemic lupus erythematosusD008180EFO_0002690M321113
PostmenopauseD017698112
Rheumatoid arthritisD001172EFO_0000685M06.9112
Breast neoplasmsD001943EFO_0003869C50112
LymphomaD008223C85.9111
Fertility preservationD059247111
OvulationD01006011
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B203115
PregnancyD011247EFO_0002950Z33.11113
Endometrial hyperplasiaD004714N85.0213
HyperplasiaD006965EFO_0000536213
Polycystic ovary syndromeD011085EFO_0000660E28.2112
SyndromeD013577112
HyperandrogenismD01758822
Non-small-cell lung carcinomaD00228911
Lung neoplasmsD008175C34.9011
Myeloid leukemia acuteD015470C92.011
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B20213
PharmacokineticsD01059922
Hepatitis cD006526B19.222
NeoplasmsD009369C8022
Pregnancy rateD018873112
Type 2 diabetes mellitusD003924EFO_0001360E1122
Bacterial infectionsD001424A4911
HepatitisD006505K75.911
HepacivirusD01617411
Biological availabilityD00168211
Show 13 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood coagulation disordersD001778EFO_0009314D68.922
Hemostatic disordersD02014122
Pituitary diseasesD010900E23.711
Precursor t-cell lymphoblastic leukemia-lymphomaD05421811
MicrobiotaD06430711
Venous thromboembolismD054556EFO_0004286I7411
Pulmonary embolismD011655EFO_0003827I2611
EmbolismD00461711
Intracranial thrombosisD02076711
ThromboembolismD01392311
Show 21 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
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Oriahnn AbbVie
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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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Ryeqo Myovant Sciences
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Tabular view
Estimated US medical usage
Norethindrone
+
Estradiol
Total medical expenditures per year (USD, in millions)
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Norethindrone
+
Ethinyl estradiol
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Norethindrone
+
Mestranol
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Norethindrone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 76,838 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,312 adverse events reported
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