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
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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Norgestimate
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 | 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
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 | — | — | 3 | 1 | 2 | 2 | 2 | 10 |
| Contraception behavior | D003268 | — | — | 1 | — | — | 1 | 1 | 3 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | — | 1 | — | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 2 | — | 2 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | 1 | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
| Perimenopause | D047648 | — | — | — | — | — | 1 | — | 1 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | 1 | — | — | 1 |
| Premature menopause | D008594 | — | E28.31 | — | — | 1 | — | — | 1 |
| Ovarian cysts | D010048 | — | N83.1 | — | 1 | 1 | — | — | 1 |
| Cysts | D003560 | — | — | — | 1 | 1 | — | — | 1 |
| 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 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
| Metrorrhagia | D008796 | — | N92.1 | — | 1 | — | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | — | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Hepatitis c | D006526 | — | B19.2 | 3 | — | — | — | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | — | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | — | I82.40 | — | — | — | — | 1 | 1 |
| 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 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 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 | 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
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Alternate
TRPC3
TRPC3
TRPC6
TRPC6
Variants
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Financial
Revenue by drug
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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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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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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 997 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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