Pomalidomide
As of the edition of 20 October 2026, Pomalidomide is a small molecule: marketed, first approved in 2013 (US); acts on CRBN; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Pomalyst
- First approved
- 8 February 2013 (US)
- Approvals on record
- 14 in 6 regions
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 261, 51 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Nutrition and metabolism; Infections
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Bristol Myers Squibb.
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 product20 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| CRBN | Protein cereblon | Q96SW2 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 6 | 5 | 0 |
| Phase 1 | 64 | 30 | 16 | 16 |
| Phase 2 | 147 | 51 | 49 | 32 |
| Phase 3 | 31 | 9 | 18 | 2 |
| Phase 4 | 3 | 0 | 1 | 1 |
| All trials | 261 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator, Applicant and Lead sponsor of trials | 2003 to now |