Norethindrone
As of the edition of 20 October 2026, Norethindrone is a small molecule: marketed, first approved in 1959 (CH); acts on PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Norminest Fe
- First approved
- 3 June 1959 (CH)
- Approvals on record
- 86 in 6 regions
- Holder of the most recent approval
- Millicent Manufacturing Pr; 23 holders in all
- Registered trials
- 31, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Cancer; Hormones; Immune system; Infections
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Norethindrone.
See the 3 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 | 2 | 1 | 0 | 1 |
| Phase 1 | 13 | 12 | 0 | 1 |
| Phase 2 | 4 | 2 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 5 | 4 | 0 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 1959 to now |
| Pfizer | Applicant and Later holder | 1976 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2004 to now |
| Teva | Acquired holder and Lead sponsor of trials | 2006 to now |
| ASKA Pharmaceutical | Later holder | 2008 to now |
| Duramed | Acquired holder | 2009 to now |
| AbbVie | Later holder | 2013 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2015 to now |
| Actavis | Later holder |