Obeticholic acid
As of the edition of 20 October 2026, Obeticholic acid is a small molecule: marketed, first approved in 2016 (US); acts on NR1H4; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Ocaliva
- First approved
- 27 May 2016 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Alfasigma
- Withdrawn from market
- 30 August 2024 (in some regions)
- Registered trials
- 33, 9 stopped early
- Disease areas
- Digestive system; Inherited and neonatal; Cancer; Skin and connective tissue; Chemically induced; Infections
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Alfasigma.
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 product4 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 Obeticholic acid.
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 |
|---|---|---|
| NR1H4 | Bile acid receptor | Q96RI1 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 0 | 1 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 14 | 8 | 1 | 5 |
| Phase 3 | 7 | 4 | 1 | 1 |
| Phase 4 | 2 | 0 | 0 | 2 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alfasigma | Originator and Lead sponsor of trials | 2007 to now |