Etonogestrel
As of the edition of 20 October 2026, Etonogestrel is a small molecule: marketed, first approved in 1999 (FR); acts on PGR; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Nuvaring
- First approved
- 25 May 1999 (FR)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- ORGANON FARMACĂUTICA LTDA.; 5 holders in all
- Registered trials
- 47, 4 stopped early
- Disease areas
- Urinary and reproductive; Infections; Immune system; Pregnancy and women's health; Blood and lymph; Chemically induced
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Organon.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Etonogestrel.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 15 | 1 | 2 |
| Phase 1 | 3 | 0 | 1 | 1 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 4 | 3 | 0 | 0 |
| Phase 4 | 17 | 15 | 1 | 0 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant and Lead sponsor of trials | 2001 to now |