Norelgestromin
As of the edition of 20 October 2026, Norelgestromin is a small molecule: marketed, first approved in 2001 (US); acts on PGR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Small molecule
- Brand name
- Ortho Evra
- First approved
- 20 November 2001 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Viatris; 3 holders in all
- Registered trials
- 9, 0 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Immune system; Infections
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gedeon Richter | Applicant | 2002 to now |