Drug

Eluxadoline

As of the edition of 20 October 2026, Eluxadoline is a small molecule: marketed, first approved in 2015 (US); acts on OPRM1; US protection ends in 2029.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2017
Kind
Small molecule
Brand name
Viberzi
First approved
27 May 2015 (US)
Approvals on record
4 in 2 regions
Holder of the most recent approval
AbbVie
Withdrawn from market
18 December 2020 (in some regions)
Registered trials
8, 2 stopped early
Disease areas
Digestive system; Hormones; Mental health; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive

US protection

US protection ends in 2029.

The last listed US drug-substance patent ends in 2029. The application that gives this date is held by AbbVie.

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 product

6 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.

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 product

1 company is on route B because of Eluxadoline.

Target

GeneProteinUniProt
OPRM1Mu-type opioid receptorP35372

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 23201
Phase 34211
Phase 41100
All trials8

Who has held its approvals

CompanyRoleYears
AbbVieAcquired holder and Lead sponsor of trials2017 to now