Norgestimate - PharmaKB

Norgestimate

Estarylla, Ethinyl Estradiol / Norgestimate, Mili, Mono-linyah, Prefest, Previfem, Sprintec, Tri-estarylla, Tri-linyah, Tri-lo-estarylla, Tri-lo-linyah, Tri-lo-mili, Tri-mili (norgestimate) is a small molecule pharmaceutical. Norgestimate was first approved as Ortho cyclen-21 on 1989-12-29. It is used to treat amenorrhea, female infertility, and uterine hemorrhage in the USA. It is known to target short transient receptor potential channel 3 and short transient receptor potential channel 6.

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Clinical

Drug

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Variants

Financial

Trends

Safety

Events Timeline

YTD

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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 diseases	D000091642
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Combinations

Estarylla, Mili, Mono-linyah, Norgestimate ethinyl estradiol, Previfem, Sprintec, Tri lo sprintec, Tri-estarylla, Tri-linyah, Tri-lo-estarylla, Tri-lo-linyah, Tri-lo-mili, Tri-mili, Tri-sprintec (discontinued: Estradiol norgestimate, Norgestimate ethinyl estradiol, Ortho cyclen, Ortho tri-cyclen, Ortho tri-cyclen lo, Prefest, Tri-previfem)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Estradiol

Norgestimate

Tradename	Company	Number	Date	Products
PREFEST	Teva	N-021040 DISCN	1999-10-22	1 products, RLD

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Ethinyl estradiol

Norgestimate

Tradename	Company	Number	Date	Products
ORTHO CYCLEN-21	Johnson & Johnson	N-019653 DISCN	1989-12-29	1 products
ORTHO CYCLEN-28	Johnson & Johnson	N-019653 DISCN	1989-12-29	1 products, RLD
ORTHO TRI-CYCLEN	Johnson & Johnson	N-019697 DISCN	1992-07-03	2 products
ORTHO TRI-CYCLEN LO	Johnson & Johnson	N-021241 DISCN	2002-08-22	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
estarylla	ANDA	2024-10-01
femynor	ANDA	2020-12-29
mili	ANDA	2024-12-07
mono-linyah	ANDA	2025-01-20
mononessa	New Drug Application	2019-01-09
norgestimate and ethinyl estradiol	ANDA	2025-05-28
nymyo	ANDA	2022-12-08
ortho tri cyclen	New Drug Application	2012-02-27
ortho tri cyclen lo	New Drug Application	2011-02-03
ortho tri-cyclen lo	New Drug Application	2009-12-31

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
prostatic neoplasms	—	D011471	C61
breast neoplasms	EFO_0003869	D001943	C50
menorrhagia	EFO_0003945	D008595	N92.0
uterine hemorrhage	—	D014592	—
primary ovarian insufficiency	EFO_0004266	D016649	E28.3
amenorrhea	—	D000568	N91.2
female infertility	EFO_0008560	D007247	N97
hot flashes	—	D019584	—
hypogonadism	—	D007006	E23.0
premature menopause	—	D008594	E28.31

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

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

— G03AA11: Norgestimate and ethinylestradiol

— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations

— G03AB09: Norgestimate and ethinylestradiol

— G03F: Progestogens and estrogens in combination

— G03FA: Progestogens and estrogens, fixed combinations

— G03FA13: Norgestimate and estrogen

HCPCS

No data

Clinical

Clinical Trials

45 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Contraception	D003267	—	—	2	1	1	1	1	6
Hemorrhage	D006470	MP_0001914	R58	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Congenital abnormalities	D000013	EFO_0003915	Q89.9	—	—	1	—	—	1
Nervous system diseases	D009422	—	G00-G99	—	—	1	—	—	1
Hereditary congenital and neonatal diseases and abnormalities	D009358	—	—	—	—	1	—	—	1
Neural tube defects	D009436	—	Q00.0	—	—	1	—	—	1
Nervous system malformations	D009421	—	Q00-Q07	—	—	1	—	—	1
Spinal dysraphism	D016135	EFO_1001210	Q05	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Thrombosis	D013927	—	—	—	1	—	—	—	1
Insulin resistance	D007333	EFO_0002614	E88.819	—	1	—	—	—	1
Inflammation	D007249	MP_0001845	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	4	—	—	—	—	4
Healthy volunteers/patients	—	—	—	2	—	—	—	—	2
Drug interactions	D004347	—	—	2	—	—	—	—	2
Therapeutic equivalency	D013810	—	—	2	—	—	—	—	2

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Venous thromboembolism	D054556	EFO_0004286	I74	—	—	—	—	1	1
Myocardial infarction	D009203	EFO_0000612	I21	—	—	—	—	1	1
Thromboembolism	D013923	—	—	—	—	—	—	1	1
Infarction	D007238	EFO_0009463	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Norgestimate
INN	norgestimate
Description	Norgestimate is a steroid ester, a ketoxime and a terminal acetylenic compound. It has a role as a contraceptive drug, a progestin and a synthetic oral contraceptive.
Classification	Small molecule
Drug class	progestins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C#C[C@]1(OC(C)=O)CC[C@H]2[C@@H]3CCC4=C/C(=N/O)CC[C@@H]4[C@H]3CC[C@@]21CC

Identifiers

PDB	—
CAS-ID	35189-28-7
RxCUI	—
ChEMBL ID	CHEMBL1200934
ChEBI ID	50815
PubChem CID	6540478
DrugBank	DB00957
UNII ID	C291HFX4DY (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

TRPC3

TRPC6

Organism

Homo sapiens

Gene name

TRPC3

Gene synonyms

TRP3

NCBI Gene ID

7222

Protein name

short transient receptor potential channel 3

Protein synonyms

hTrp-3, hTrp3, Transient receptor protein 3, TRP-3

Uniprot ID

Q5G1L5

Mouse ortholog

Trpc3 (22065)

short transient receptor potential channel 3 (Q9QZC1)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Norgestimate

Estradiol

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Refill frequency

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Price per prescription (USD)

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Norgestimate

Ethinyl estradiol

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 991 documents

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Safety

Black-box Warning

Black-box warning for: Estarylla, Femynor, Mili, Mono-linyah, Mononessa, Norgestimate and ethinyl estradiol, Nymyo, Ortho tri-cyclen lo, Previfem, Sprintec, Tri femynor, Tri-estarylla, Tri-linyah, Tri-lo- estarylla, Tri-lo-marzia, Tri-lo-mili, Tri-lo-sprintec, Tri-mili, Tri-nymyo, Tri-sprintec, Tri-vylibra, Tri-vylibra lo, Trinessa, Vylibra

Adverse Events

Top Adverse Reactions

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5,360 adverse events reported

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