ORTHO EVRA
LOE ApproachingNDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORTHO EVRA is a transdermal contraceptive patch containing norelgestromin and ethinyl estradiol, approved in 2001 for prevention of pregnancy. It delivers hormonal contraception through the skin as an extended-release film, offering a non-daily dosing alternative to oral pills. The patch works by suppressing ovulation and altering cervical mucus to prevent fertilization.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); team will likely shift focus to maximization and transition planning rather than aggressive growth.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
Started Mar 2011
54 enrolled
Healthy Volunteers
Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.
Started Nov 2006
440 enrolled
ContraceptionFemale ContraceptionFertility Control
A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)
Started Apr 2004
53 enrolled
ContraceptionFemale Contraception
A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
Started Aug 2002
34 enrolled
ContraceptionFemale Contraception
Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
Started Apr 2002
334 enrolled
ContraceptionFemale Contraception
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.