Interferon beta-1b
As of the edition of 20 October 2026, Interferon beta-1b is a protein: marketed, first approved in 1993 (US); acts on IFNAR1 and IFNAR2; US protection ended in 2005.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1995
- Kind
- Protein
- Brand name
- Betaseron
- First approved
- 23 July 1993 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Novartis; 4 holders in all
- Withdrawn from market
- 25 April 2025 (in some regions)
- Registered trials
- 56, 3 stopped early
- Disease areas
- Immune system; Nervous system; Infections; Cancer; Lungs and airways; Urinary and reproductive
US protection
US protection ended in 2005.
US protection ended in 2005, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Bayer. The date is computed, not published.
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.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 35 | 33 | 1 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 9 | 6 | 0 | 0 |
| Phase 3 | 6 | 5 | 0 | 1 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 56 |