FDA · United States
ethinyl estradiol — FDA regulatory status
ethinyl estradiol (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Estrogen receptor alpha agonist
- Target
- Estrogen receptor
- Structured fields
- 8
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Estrogen receptor alpha agonist. Target: Estrogen receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 87 published clinical programs and 11 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 1305-0069 | Phase 3 | Boehringer Ingelheim | 2025-522383-33-00 |
| AROAPOC3-3001 | Phase 3 | Arrowhead Pharmaceuticals Ireland | 2024-514336-24-00 |
| AZD0780 | Phase 3 | AstraZeneca | NCT07000136 |
| AZD0780 Placebo, AZD0780 | Phase 3 | AstraZeneca | 2025-520520-17-00 |
| Alirocumab | Phase 3 | Regeneron UK | NCT03156621 |
| CKJX839C12303 | Phase 3 | Novartis India | 2024-514594-21-00 |
| CKJX839C12304 | Phase 3 | Novartis India | 2024-514595-41-00 |
| Evinacumab | Phase 3 | Ultragenyx UK | NCT05611528 |
| Evolocumab | Phase 3 | Amgen | NCT01624142 |
| INCLISIRAN, - | Phase 3 | Novartis India | 2023-507278-41-00 |
| ISIS 678354 | Phase 3 | IONIS PHARMACEUTICALS | 2023-508815-22-00 |
| ISIS 678354-CS13 | Phase 3 | IONIS PHARMACEUTICALS | 2023-509029-29-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12398140 | Substituted pyrrolo [2,3-d]pyrimidines for treating familial dysautonomia | US |
| 12384797 | Thioeno[3,2-b] pyridin-7-amine compounds for treating familial dysautonomia | US |
| 11306155 | Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody | US |
| 11191750 | Use of mTOR inhibitors for treatment of familial adenomatous polyposis | US |
| 11111317 | Cordyceps militaris medium polysaccharide, method for separating and purifying same, and use thereof | US |
| 11033494 | Apparatuses containing an emulsion and methods of manufacture | US |
| 10544232 | Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody | US |
| 10072066 | Methods and compositions for treatment of a beta thalessemia | US |
| 8415332 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens | US |
| 7855190 | Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration | US |
| 6331564 | Use of triaryl methane compounds for inhibiting unwanted cellular proliferation associated with inflammatory disease | US |
Related hubs
FAQ
What is the FDA approval status of ethinyl estradiol?
ethinyl estradiol currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ethinyl estradiol regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to ethinyl estradiol?
This spoke lists 87 published programs associated with ethinyl estradiol in our pipeline index.