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Ethinyl estradiol and norelgestromin
Ethinyl estradiol and norelgestromin, marketed by the University of Vermont, is a hormonal contraceptive with a well-established presence in the market. The key composition patent is set to expire in 2028, providing a significant period of exclusivity and potential revenue protection. However, the primary risk lies in the competitive landscape, where the drug may face increased generic competition post-patent expiry.
At a glance
| Generic name | Ethinyl estradiol and norelgestromin |
|---|---|
| Also known as | Ortho Evra |
| Sponsor | University of Vermont |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users (PHASE2)
- Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles (PHASE3)
- Inpatient Adolescent Contraception (EARLY_PHASE1)
- A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED) (PHASE4)
- Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis (PHASE4)
- A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control
- Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
- 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.
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ethinyl estradiol and norelgestromin CI brief — competitive landscape report
- Ethinyl estradiol and norelgestromin updates RSS · CI watch RSS
- University of Vermont portfolio CI