Norethindrone - PharmaKB

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, Rhuzdah, 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

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Variants

Financial

Trends

Safety

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
skin and connective tissue diseases	D017437
endocrine system diseases	D004700
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Nor-qd (generic drugs available since 1987-01-29, discontinued: Aygestin, Micronor, Norlutate, Norlutin)

Combinations

Activella, Combipatch, Lo loestrin fe, Myfembree, Rhuzdah, Taytulla, Tri-norinyl (generic drugs available since 1987-01-29, discontinued: Balziva, Brevicon, Cyclafem, Estrostep, Estrostep fe, Femcon fe, Femhrt, Gencept, Gildess, Lo minastrin fe, Loestrin, Loestrin 21, Lupaneta pack, Microgestin, Minastrin, Modicon, N.e.e., Norcept, Norethin, Norethin 1/50m, Norinyl, Norinyl 1+35, Norinyl 1+50, Norinyl 1+80, Norlestrin, Norlestrin 21, Norquest fe, Nortrel, Ortho-novum, Ovcon, Pirmella)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Estradiol

Norethindrone acetate

Tradename	Company	Number	Date	Products
ACTIVELLA	Amneal Pharmaceuticals	N-020907 RX	1998-11-18	1 products, RLD, RS
COMBIPATCH	Noven Pharmaceuticals	N-020870 RX	1998-08-07	2 products, RLD, RS

Show 1 discontinued

Estradiol

Norethindrone acetate

Relugolix

Tradename	Company	Number	Date	Products
MYFEMBREE	Myovant Sciences	N-214846 RX	2021-05-26	1 products, RLD, RS

Ethinyl estradiol

Ferrous fumarate

Norethindrone

Tradename	Company	Number	Date	Products
NORQUEST FE	Mylan	N-018926 DISCN	1986-07-18	1 products

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Ethinyl estradiol

Ferrous fumarate

Norethindrone acetate

Tradename	Company	Number	Date	Products
NORLESTRIN FE 1/50	Pfizer	N-016766 DISCN	1982-01-01	1 products
NORLESTRIN FE 2.5/50	Pfizer	N-016854 DISCN	1982-01-01	1 products

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Ethinyl estradiol

Norethindrone

Tradename	Company	Number	Date	Products
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Allergan	N-022573 RX	2010-12-22	1 products, RLD, RS
TRI-NORINYL 28-DAY	Dr Reddys Laboratories	N-018977 RX	1984-04-13	1 products, RLD, RS

Show 20 discontinued

Ethinyl estradiol

Norethindrone acetate

Tradename	Company	Number	Date	Products
LO LOESTRIN FE	Allergan	N-022501 RX	2010-10-21	1 products, RLD, RS
TAYTULLA	Allergan	N-204426 RX	2013-04-19	1 products, RLD, RS

Show 13 discontinued

Leuprolide acetate

Norethindrone acetate

Tradename	Company	Number	Date	Products
LUPANETA PACK	AbbVie	N-203696 DISCN	2012-12-14	2 products, RLD

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Mestranol

Norethindrone

Tradename	Company	Number	Date	Products
NORINYL 1+50 21-DAY	Allergan	N-013625 DISCN	1982-01-01	1 products
NORINYL	Allergan	N-013625 DISCN	1982-01-01	1 products
NORINYL 1+50 28-DAY	Allergan	N-016659 DISCN	1982-01-01	1 products, RLD
NORINYL 1+80 21-DAY	G.D. Searle	N-016724 DISCN	1982-01-01	1 products
NORINYL 1+80 28-DAY	G.D. Searle	N-016725 DISCN	1982-01-01	1 products
ORTHO-NOVUM 1/50 28	Johnson & Johnson	N-016709 DISCN	1982-01-01	1 products
ORTHO-NOVUM 10-21	Johnson & Johnson	N-012728 DISCN	1982-01-01	1 products
ORTHO-NOVUM 1/50 21	Johnson & Johnson	N-012728 DISCN	1982-01-01	1 products
ORTHO-NOVUM 2-21	Johnson & Johnson	N-012728 DISCN	1982-01-01	1 products
ORTHO-NOVUM 1/80 21	Johnson & Johnson	N-016715 DISCN	1982-01-01	1 products
ORTHO-NOVUM 1/80 28	Johnson & Johnson	N-016715 DISCN	1982-01-01	1 products

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Norethindrone

Tradename	Company	Number	Date	Products
NOR-QD	Teva	N-017060 RX	1982-01-01	1 products, RLD, RS

Show 2 discontinued

Norethindrone acetate

Tradename	Company	Number	Date	Products
AYGESTIN	Duramed Pharmaceuticals	N-018405 DISCN	1982-04-21	1 products, RLD
NORLUTATE	Pfizer	N-012184 DISCN	1982-01-01	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
activella	New Drug Application	2020-03-31
affodel	ANDA	2022-09-20
alyacen 1/35	ANDA	2023-06-07
alyacen 1/35 alyacen 7/7/7	ANDA	2017-09-08
alyacen 7/7/7	ANDA	2021-03-18
amabelz	ANDA	2024-01-10
aranelle	ANDA	2023-01-31
aurovela 1.5/30	ANDA	2023-11-21
aurovela 1/20	ANDA	2023-11-21
aurovela 24 fe	ANDA	2023-11-21

Show 102 more

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acne vulgaris	EFO_0003894	D000152	L70
endometrial hyperplasia	—	D004714	N85.0
endometriosis	EFO_0001065	D004715	N80
hypogonadism	HP_0000815	D007006	E23.0
menorrhagia	HP_0000132	D008595	N92.0

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

Patent Expiration

Patent	Expires	Flag	FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
11033551	2037-09-29		U-3129
9346822	2024-02-17		U-3129
7300935	2024-01-28	DP
8058280	2024-01-28	DP
Ethinyl Estradiol / Norethindrone Acetate, Lo Loestrin Fe, Apil
7704984	2029-02-02		U-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

170 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	—	2	1	1	21
Endometriosis	D004715	EFO_0001065	N80	—	4	10	1	2	17
Leiomyoma	D007889	HP_0000131	D25	—	2	10	1	2	15
Contraception	D003267	—	—	1	1	5	4	4	15
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	7	2	4	13
Menopause	D008593	EFO_0003922	N95	2	—	1	4	2	9
Dysmenorrhea	D004412	HP_0100607	N94.6	—	—	6	1	1	8
Pelvic pain	D017699	—	—	—	1	2	2	2	7
Hiv	D006678	—	O98.7	1	—	—	1	3	5
Metrorrhagia	D008796	HP_0100608	N92.1	—	—	1	3	—	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Contraception behavior	D003268	—	—	1	—	1	—	2	4
Systemic lupus erythematosus	D008180	HP_0002725	M32	1	—	1	—	1	3
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	1	—	1	—	—	2
Lymphoma	D008223	—	C85.9	—	1	1	—	—	1
Fertility preservation	D059247	—	—	—	1	1	—	—	1
Ovulation	D010060	—	—	—	—	1	—	—	1
Postmenopause	D017698	—	—	—	—	1	—	—	1
Hot flashes	D019584	—	—	—	—	1	—	—	1
Breast neoplasms	D001943	EFO_0003869	C50	—	—	1	—	—	1
Dyspareunia	D004414	HP_0030016	N94.1	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy	D011247	EFO_0002950	Z33.1	1	1	—	—	1	3
Hiv infections	D015658	EFO_0000764	B20	1	1	—	—	1	3
Endometrial hyperplasia	D004714	—	N85.0	—	2	—	—	1	3
Polycystic ovary syndrome	D011085	EFO_0000660	E28.2	1	1	—	—	—	2
Non-small-cell lung carcinoma	D002289	—	—	—	1	—	—	—	1
Myeloid leukemia acute	D015470	—	C92.0	—	1	—	—	—	1
Myeloproliferative disorders	D009196	—	D47.1	—	1	—	—	—	1
Non-hodgkin lymphoma	D008228	—	C85.9	—	1	—	—	—	1
Multiple myeloma	D009101	—	C90.0	—	1	—	—	—	1
Hodgkin disease	D006689	—	C81	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Benign familial pemphigus	D016506	—	Q82.8	1	—	—	—	3	4
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	—	—	—	1	2
Pharmacokinetics	D010599	—	—	2	—	—	—	—	2
Neoplasms	D009369	—	C80	2	—	—	—	—	2
Pregnancy rate	D018873	—	—	1	—	—	—	1	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	2	—	—	—	—	2
Darier disease	D007644	Orphanet_218	E50.8	1	—	—	—	1	2
Bacterial infections	D001424	—	A49	1	—	—	—	—	1
Hepacivirus	D016174	—	—	1	—	—	—	—	1
Biological availability	D001682	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy complications	D011248	—	—	—	—	—	—	2	2
Blood coagulation disorders	D001778	EFO_0009314	D68.9	—	—	—	—	1	1
Microbiota	D064307	—	—	—	—	—	—	1	1
Pulmonary embolism	D011655	HP_0002204	I26	—	—	—	—	1	1
Intracranial sinus thrombosis	D012851	—	—	—	—	—	—	1	1
Osteoporosis	D010024	HP_0000939	M81.0	—	—	—	—	1	1
Turner syndrome	D014424	Orphanet_881	Q96	—	—	—	—	1	1
Myocardial ischemia	D017202	EFO_1001375	I20-I25	—	—	—	—	1	1
Headache	D006261	HP_0002315	R51	—	—	—	—	1	1
Appetitive behavior	D001070	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Norethindrone
INN	norethisterone
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 class	Progestogen (medication); Progestin
Image (chem structure or protein)
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-ID	68-22-4
RxCUI	—
ChEMBL ID	CHEMBL1162
ChEBI ID	7627
PubChem CID	6230
DrugBank	DB00717
UNII ID	T18F433X4S (ChemIDplus, GSRS)

Target

Agency Approved

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

€

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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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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

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Activella, Amabelz, 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 7/7/7, Cyonanz, Dasetta 1/35, Dasetta 7/7/7, Deblitane, Estradiol / norethindrone acetate, Estradiol and norethindrone acetate, Finzala, Fyavolv, Gemmily, Hailey 24 fe, Hailey fe 1.5/30, Hailey fe 1/20, Jinteli, Junel, Junel fe, 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, 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 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, Tarina 24 fe, Taysofy, Taytulla, Tilia fe, Tri-legest fe, Wera, Wymzya fe, Zenchent fe

Adverse Events

Top Adverse Reactions

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14,072 adverse events reported

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