Norgestimate
Ortho, Ortho Tri-cyclen, Prefest, Tri-previfem (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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
No data
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 |
|---|---|---|---|---|
| PREFEST | Teva | N-021040 DISCN | 1999-10-22 | 1 products, RLD |
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Ethinyl estradiol
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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 | 2023-02-01 |
| milia remover serum | OTC monograph final | 2023-04-07 |
| mono-linyah | ANDA | 2020-02-25 |
| ortho cyclen ortho tri cyclen | New Drug Application | 2019-05-16 |
| prefest | ANDA | 2016-02-29 |
| previfem | ANDA | 2018-12-20 |
| tri-estarylla | ANDA | 2023-03-02 |
| tri-linyah | ANDA | 2018-11-28 |
| tri-lo-mili | ANDA | 2023-01-01 |
| tri-mili | ANDA | 2021-12-03 |
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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
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
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Indications Without Phase
No data
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 | 31994 |
| ChEMBL ID | CHEMBL1200934 |
| ChEBI ID | 50815 |
| PubChem CID | 6540478 |
| DrugBank | DB00957 |
| UNII ID | C291HFX4DY (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TRPC3
TRPC3
TRPC6
TRPC6
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:

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Safety
Black-box Warning
Black-box warning for: Estarylla, Mono-linyah
, Ortho cyclen ortho tri cyclen, Previfem, Tri-estarylla, Tri-linyah
, Tri-lo-mili, Tri-mili, Tri-sprintec
Adverse Events
Top Adverse Reactions

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5 adverse events reported
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