Drug

Voclosporin

As of the edition of 20 October 2026, Voclosporin is a protein: marketed, first approved in 2021 (US); acts on PPP3CA; US protection ends in 2027.

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

The drug

Status
Marketed; latest approval 2024
Kind
Protein
Brand name
Lupkynis
First approved
22 January 2021 (US)
Approvals on record
4 in 4 regions
Holder of the most recent approval
Otsuka; 3 holders in all
Registered trials
21, 5 stopped early
Disease areas
Immune system; Pregnancy and women's health; Skin and connective tissue; Urinary and reproductive; Eye; Infections

US protection

US protection ends in 2027.

The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Aurinia Pharmaceuticals.

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

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

See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.

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 product

2 companies are on route B because of Voclosporin.

Target

GeneProteinUniProt
PPP3CAProtein phosphatase 3 catalytic subunit alphaQ08209

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3110
Phase 13300
Phase 26402
Phase 38413
Phase 41010
All trials21

Who has held its approvals

CompanyRoleYears
Aurinia PharmaceuticalsOriginator and Lead sponsor of trials2013 to now
OtsukaApplicant and Lead sponsor of trials2022 to now