Lurbinectedin
As of the edition of 20 October 2026, Lurbinectedin is a small molecule: marketed, first approved in 2020 (US); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Zepzelca
- First approved
- 15 June 2020 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Pharma Mar S.A.; 3 holders in all
- Registered trials
- 58, 6 stopped early
- Disease areas
- Cancer; Lungs and airways; Hormones; Pregnancy and women's health; Urinary and reproductive; Skin and connective tissue
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Jazz Pharmaceuticals.
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 product4 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 13 | 9 | 2 | 1 |
| Phase 2 | 35 | 9 | 19 | 5 |
| Phase 3 | 7 | 3 | 4 | 0 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Jazz Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2020 to now |