Levonorgestrel
As of the edition of 20 October 2026, Levonorgestrel is a small molecule: marketed, first approved in 1975 (ES); acts on PGR; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Lo/ovral Fe
- First approved
- 1 April 1975 (ES)
- Approvals on record
- 52 in 7 regions
- Holder of the most recent approval
- Exeltis; 17 holders in all
- Registered trials
- 157, 12 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Infections; Immune system; Hormones
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Medicines360 holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Levonorgestrel.
See the 4 companies 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 | 41 | 33 | 4 | 2 |
| Phase 1 | 44 | 39 | 1 | 3 |
| Phase 2 | 18 | 12 | 2 | 0 |
| Phase 3 | 32 | 21 | 4 | 4 |
| Phase 4 | 22 | 17 | 1 | 3 |
| All trials | 157 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 1983 to now |
| Bayer | Applicant, Acquired holder and Lead sponsor of trials | 1987 to now |
| Pfizer | Later holder and Lead sponsor of trials | 1990 to now |
| Population Council | Applicant | 1990 to now |
| Population Council Center For Biomedical | Acquired holder | 2003 to now |
| Libbs Farmacêutica LTDA | Applicant | 2005 to now |
| Teva | Later holder and Lead sponsor of trials | 2009 to now |
| Sosei | Applicant | 2011 to now |
| Medicines360 | Later holder | 2015 to now |
| Nobelpharma | Later holder and Lead sponsor of trials | 2015 to now |
| Foundation Consumer Healthcare | Acquired holder | 2018 to now |