Drospirenone
As of the edition of 20 October 2026, Drospirenone is a small molecule: marketed, first approved in 2001 (ES); acts on NR3C2 and 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 2021
- Kind
- Small molecule
- Brand name
- Yasmin
- First approved
- 1 February 2001 (ES)
- Approvals on record
- 28 in 8 regions
- Holder of the most recent approval
- ASKA Pharmaceutical; 11 holders in all
- Registered trials
- 66, 8 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Cancer; Hormones; Heart and blood vessels; Nutrition and metabolism
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.
Pfizer holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Drospirenone.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 6 | 3 | 0 |
| Phase 1 | 20 | 12 | 1 | 4 |
| Phase 2 | 12 | 7 | 2 | 3 |
| Phase 3 | 11 | 9 | 1 | 0 |
| Phase 4 | 9 | 3 | 3 | 1 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 2002 to now |
| Exeltis | Applicant | 2019 to now |
| Estetra SPRL | Later holder | 2021 to now |
| Gedeon Richter | Applicant | 2021 to now |
| ASKA Pharmaceutical | Applicant | 2025 to now |