Norgestrel
As of the edition of 20 October 2026, Norgestrel is a small molecule: marketed, first approved in 1974 (CH); acts on PGR; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Lo/ovral
- First approved
- 1 April 1974 (CH)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Pfizer; 5 holders in all
- Registered trials
- 4, 1 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by Laboratoire Hra Pharma.
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.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Laboratoire Hra Pharma | Acquired holder | 2015 to now |
| Pfizer | Earlier holder |