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Drug ReportsNorelgestromin
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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Events Timeline
5D
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3M
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YTD
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2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
therapeuticsD013812
Trade Name
FDA
EMA
Combinations
Ethinyl estradiol norelgestromin, Onsura, Xulane (discontinued: Ortho evra)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
+
Norelgestromin
Tradename
Company
Number
Date
Products
ORTHO EVRAJohnson & JohnsonN-021180 DISCN2001-11-20
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
norelgestromin and ethinly estradiolANDA2022-03-30
norelgestromin and ethinyl estradiolANDA2023-09-16
xulaneANDA2024-02-27
zafemyANDA2024-01-05
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
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
— G03AA13: Norelgestromin and ethinylestradiol
HCPCS
No data
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNorelgestromin
INNnorelgestromin
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 classestrogens; progestins
Image (chem structure or protein)Loading
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-ID53016-31-2
RxCUI—
ChEMBL IDCHEMBL1200807
ChEBI ID—
PubChem CID62930
DrugBankDB06713
UNII IDR0TAY3X631 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Norelgestromin
+
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 515 documents
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Safety
Black-box Warning
Black-box warning for: Norelgestromin and ethinly estradiol, Xulane, Zafemy
Adverse Events
Top Adverse Reactions
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22,546 adverse events reported
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