Apremilast
As of the edition of 20 October 2026, Apremilast is a small molecule: marketed, first approved in 2014 (US); acts on PDE4A, PDE4B and PDE4C and 1 more; US protection ends in 2028.
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
- Otezla
- First approved
- 21 March 2014 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Amgen; 4 holders in all
- Registered trials
- 125, 12 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; Inherited and neonatal; Immune system; Infections; Heart and blood vessels
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by Amgen.
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 product26 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Apremilast.
See the 4 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 | 16 | 10 | 4 | 1 |
| Phase 1 | 11 | 7 | 3 | 1 |
| Phase 2 | 40 | 30 | 2 | 6 |
| Phase 3 | 30 | 20 | 8 | 0 |
| Phase 4 | 28 | 18 | 2 | 4 |
| All trials | 125 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator, Applicant and Lead sponsor of trials | 2014 to now |
| Amgen | Applicant, Acquired holder and Lead sponsor of trials | 2015 to now |