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Drug ReportsNorgestimate
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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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
signs and symptoms pathological conditionsD013568
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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Norgestimate
Tradename
Company
Number
Date
Products
PREFESTTevaN-021040 DISCN1999-10-22
1 products, RLD
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Ethinyl estradiol
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Norgestimate
Tradename
Company
Number
Date
Products
ORTHO CYCLEN-21Johnson & JohnsonN-019653 DISCN1989-12-29
1 products
ORTHO CYCLEN-28Johnson & JohnsonN-019653 DISCN1989-12-29
1 products, RLD
ORTHO TRI-CYCLENJohnson & JohnsonN-019697 DISCN1992-07-03
2 products
ORTHO TRI-CYCLEN LOJohnson & JohnsonN-021241 DISCN2002-08-22
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
estaryllaANDA2024-10-01
femynorANDA2020-12-29
meoly milia remover serumOTC monograph final2023-08-17
miliANDA2022-03-25
milia remover treatmentC2002632024-03-22
mono-linyahANDA2024-07-09
mononessaNew Drug Application2019-01-09
norgestimate and ethinyl estradiolANDA2024-10-03
nymyoANDA2022-12-08
ortho tri cyclenNew Drug Application2012-02-27
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
uterine hemorrhage—D014592—
primary ovarian insufficiencyEFO_0004266D016649E28.3
amenorrhea—D000568N91.2
female infertilityEFO_0008560D007247N97
hot flashes—D019584—
hypogonadismHP_0000044D007006E23.0
premature menopauseHP_0008209D008594E28.31
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
665 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNorgestimate
INNnorgestimate
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 classprogestins
Image (chem structure or protein)Loading
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-ID35189-28-7
RxCUI—
ChEMBL IDCHEMBL1200934
ChEBI ID50815
PubChem CID6540478
DrugBankDB00957
UNII IDC291HFX4DY (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
TRPC3
TRPC3
TRPC6
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
$
€
£
â‚£
No data
Estimated US medical usage
Norgestimate
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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
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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 43,450 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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7,776 adverse events reported
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