Luliconazole
As of the edition of 20 October 2026, Luliconazole is a small molecule: marketed, first approved in 2013 (US); US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Luzu
- First approved
- 14 November 2013 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- SATO Pharmaceutical; 2 holders in all
- Registered trials
- 8, 0 stopped early
- Disease areas
- Infections; Skin and connective tissue
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Bausch Health.
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 product3 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 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 2015 to now |
| SATO Pharmaceutical | Applicant and Lead sponsor of trials | 2016 to now |
| Medicis Pharmaceutical | Originator | 2013 to 2021 |