Phenobarbital
As of the edition of 20 October 2026, Phenobarbital is a small molecule: marketed, first approved in 1925 (ES); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Sezaby
- First approved
- 1 November 1925 (ES)
- Approvals on record
- 6 in 6 regions
- Holder of the most recent approval
- PHARLAB INDÚSTRIA FARMACÊUTICA S.A.; 6 holders in all
- Withdrawn from market
- 1 January 1985 (in some regions)
- Registered trials
- 16, 4 stopped early
- Disease areas
- Nervous system; Chemically induced; Mental health; Heart and blood vessels; Inherited and neonatal; Injuries
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by SUN Pharmaceutical Industries.
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 product1 listing counts 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 | 6 | 4 | 0 | 2 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 7 | 4 | 1 | 1 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Nobelpharma | Applicant | 2008 to now |
| SUN Pharmaceutical Industries | Applicant | 2022 to now |