Terlipressin
As of the edition of 20 October 2026, Terlipressin is a protein: marketed, first approved in 1982 (CH); acts on AVPR1A, AVPR1B and AVPR2; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Terlivaz
- First approved
- 2 December 1982 (CH)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Byk-Mallinckrodt CIL; 4 holders in all
- Registered trials
- 58, 2 stopped early
- Disease areas
- Digestive system; Pregnancy and women's health; Urinary and reproductive; Infections; Cancer; Hormones
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Byk-Mallinckrodt CIL.
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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Terlipressin.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 13 | 3 | 1 |
| Phase 2 | 9 | 5 | 0 | 1 |
| Phase 3 | 16 | 11 | 1 | 0 |
| Phase 4 | 9 | 3 | 0 | 0 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferring Pharmaceuticals | Applicant and Lead sponsor of trials | 1982 to now |
| Byk-Mallinckrodt CIL | Applicant and Lead sponsor of trials | 2004 to now |