Ortho evra, Evra(norelgestromin)
Ethinyl Estradiol / Norelgestromin, Evra, Onsura, Xulane (norelgestromin) is a small molecule pharmaceutical. Norelgestromin was first approved as Ortho evra on 2001-11-20. It is used to treat amenorrhea and uterine hemorrhage in the USA. It has been approved in Europe to treat contraception.
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Commercial
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
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Norelgestromin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORTHO EVRA | Johnson & Johnson | N-021180 DISCN | 2001-11-20 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| norelgestromin and ethinly estradiol | ANDA | 2022-03-30 |
| norelgestromin and ethinyl estradiol | ANDA | 2023-09-16 |
| xulane | ANDA | 2022-03-04 |
| zafemy | ANDA | 2024-01-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amenorrhea | — | D000568 | N91.2 |
| uterine hemorrhage | — | D014592 | — |
Agency Specific
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Clinical
Clinical Trials
36 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 | — | — | 5 | 2 | 6 | 4 | 7 | 24 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 1 | — | 4 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception behavior | D003268 | — | — | 1 | — | — | — | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 1 | 1 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | — | — | 1 | 1 |
| Menstruation disturbances | D008599 | HP_0400007 | N91.5 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Norelgestromin |
| INN | norelgestromin |
| Description | Norelgestromin, or norelgestromine, sold under the brand names Evra and Ortho Evra among others, is a progestin medication which is used as a method of birth control for women. The medication is available in combination with an estrogen and is not available alone. It is used as a patch that is applied to the skin.
|
| Classification | Small molecule |
| Drug class | estrogens; progestins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#C[C@]1(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 | 53016-31-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200807 |
| ChEBI ID | — |
| PubChem CID | 62930 |
| DrugBank | DB06713 |
| UNII ID | R0TAY3X631 (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Norelgestromin
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 484 documents
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Safety
Black-box Warning
Black-box warning for: Norelgestromin and ethinly estradiol, Norelgestromin and ethinyl estradiol, Xulane, Zafemy
Adverse Events
Top Adverse Reactions
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18,571 adverse events reported
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