Etanercept
As of the edition of 20 October 2026, Etanercept is a protein: marketed, first approved in 1998 (US); acts on TNF; US protection ended in 2010.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Protein
- Brand name
- Enbrel
- First approved
- 2 November 1998 (US)
- Approvals on record
- 19 in 5 regions
- Holder of the most recent approval
- Amgen; 6 holders in all
- Withdrawn from market
- 16 February 2020 (in some regions)
- Registered trials
- 323, 34 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; Immune system; Nutrition and metabolism; Cancer; Hormones
US protection
US protection ended in 2010.
US protection ended in 2010, 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 Amgen. 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 product2 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Etanercept.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TNF | Tumor necrosis factor | P01375 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 82 | 61 | 4 | 7 |
| Phase 1 | 29 | 21 | 1 | 3 |
| Phase 2 | 60 | 46 | 2 | 6 |
| Phase 3 | 77 | 60 | 4 | 7 |
| Phase 4 | 75 | 50 | 2 | 11 |
| All trials | 323 |