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 | 2025-04-08 |
| 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 |
Show 16 more
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
203 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 | — | — | — | 48 | 1 | — | 1 | — | 50 |
| Infections | D007239 | EFO_0000544 | — | 3 | 1 | 8 | 2 | 3 | 17 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 2 | 2 | 1 | 5 | 3 | 12 |
| Contraception | D003267 | — | — | 4 | 1 | 2 | 2 | 3 | 12 |
| Communicable diseases | D003141 | — | — | — | 1 | 8 | 2 | — | 11 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 4 | 1 | 2 | 7 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 2 | 1 | 4 | 7 |
| Bronchitis | D001991 | — | J40 | — | — | 2 | 1 | 4 | 7 |
| Acute disease | D000208 | — | — | — | — | 2 | 1 | 3 | 6 |
| Bacterial infections | D001424 | — | A49 | — | — | 1 | 3 | — | 4 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 2 | — | 2 | 5 |
| Intraabdominal infections | D059413 | — | — | — | — | 3 | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 3 | — | — | 4 |
| Community-acquired pneumonia | D000098968 | — | — | — | — | 1 | — | 1 | 2 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 2 | — | — | 2 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | 1 | — | — | 2 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 1 | — | 1 | 2 |
| Pelvic infection | D034161 | — | — | — | — | 2 | — | — | 2 |
| Pelvic inflammatory disease | D000292 | EFO_1001388 | N70-N77 | — | — | 2 | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Corneal ulcer | D003320 | — | H16.0 | — | 1 | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | — | 1 |
| Metrorrhagia | D008796 | — | N92.1 | — | 1 | — | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | — | — | — | 1 |
| Anorexia | D000855 | — | R63.0 | — | 1 | — | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | — | — | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | — | — | — | 1 |
| Infertility | D007246 | EFO_0000545 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 10 | — | — | — | — | 10 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | — | — | — | — | 4 |
| Hepatitis c | D006526 | — | B19.2 | 4 | — | — | — | — | 4 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | — | — | — | — | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | — | — | — | — | 3 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 1 | — | — | — | 1 | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 2 | — | — | — | — | 2 |
Show 37 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Venous thrombosis | D020246 | — | I82.40 | — | — | — | — | 1 | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | — | — | 1 | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | — | 1 | 1 |
| Coinfection | D060085 | — | — | — | — | — | — | 1 | 1 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 1 | 1 |
Show 15 more
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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Number of purchases
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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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
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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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5,327 adverse events reported
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