Olanzapine
As of the edition of 20 October 2026, Olanzapine is a small molecule: marketed, first approved in 1996 (EU); acts on DRD2, DRD3 and DRD4 and 2 more; 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 2025
- Kind
- Small molecule
- Brand name
- Zyprexa
- First approved
- 27 September 1996 (EU)
- Approvals on record
- 31 in 4 regions
- Holder of the most recent approval
- BIOPAS BRASIL PRODUTOS FARMACEUTICOS LTDA; 4 holders in all
- Withdrawn from market
- 12 August 2025 (in some regions)
- Registered trials
- 281, 29 stopped early
- Disease areas
- Mental health; Cancer; Nervous system; Nutrition and metabolism; Hormones; Chemically induced
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.
Alkermes holds a later exclusivity on its own new formulation or combination product, ending 2031; 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 Olanzapine.
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 | 51 | 31 | 5 | 6 |
| Phase 1 | 29 | 23 | 4 | 1 |
| Phase 2 | 40 | 21 | 6 | 4 |
| Phase 3 | 77 | 49 | 12 | 10 |
| Phase 4 | 84 | 70 | 3 | 8 |
| All trials | 281 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cheplapharm | Applicant | 1996 to now |
| Eli Lilly | Applicant and Lead sponsor of trials | 1996 to now |