Oxybate
As of the edition of 20 October 2026, Oxybate is a small molecule: marketed, first approved in 2002 (US); acts on GABBR1 and GABBR2; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Small molecule
- Brand name
- Xyrem
- First approved
- 17 July 2002 (US)
- Approvals on record
- 12 in 3 regions
- Holder of the most recent approval
- Jazz Pharmaceuticals; 5 holders in all
- Registered trials
- 50, 4 stopped early
- Disease areas
- Nervous system; Mental health; Bones, joints and muscles; Lungs and airways; Ear, nose and throat; Chemically induced
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028.
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, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 5 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Oxybate.
See the 2 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 | 4 | 3 | 1 | 0 |
| Phase 1 | 5 | 3 | 1 | 1 |
| Phase 2 | 12 | 8 | 3 | 1 |
| Phase 3 | 15 | 14 | 0 | 0 |
| Phase 4 | 14 | 10 | 2 | 2 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Jazz Pharmaceuticals | Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |
| UCB | Applicant and Lead sponsor of trials | 2005 to now |
| Avadel Cns Pharmaceuticals | Later holder | 2023 to now |
| Alkermes | Acquired holder | 2026 to now |