Avacopan
As of the edition of 20 October 2026, Avacopan is a small molecule: marketed, first approved in 2021 (JP); acts on C5AR1; US protection ends in 2039.
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
- Tavneos
- First approved
- 27 September 2021 (JP)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- CSL BEHRING COMÉRCIO DE PRODUTOS FARMACÊUTICOS LTDA; 3 holders in all
- Withdrawn from market
- 4 August 2026 (in some regions)
- Registered trials
- 21, 1 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Blood and lymph
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Amgen.
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.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Avacopan.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| C5AR1 | C5a anaphylatoxin chemotactic receptor 1 | P21730 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 10 | 9 | 1 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 3 | 1 | 2 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2009 to now |
| Kissei Pharmaceutical | Applicant and Lead sponsor of trials | 2021 to now |