Drug

Belatacept

As of the edition of 20 October 2026, Belatacept is a protein: marketed, first approved in 2011 (US); acts on CD80 and CD86; US protection ended in 2023.

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

The drug

Status
Marketed; latest approval 2011
Kind
Protein
Brand name
Nulojix
First approved
15 June 2011 (US)
Approvals on record
3 in 3 regions
Holder of the most recent approval
Bristol Myers Squibb
Registered trials
63, 8 stopped early
Disease areas
Pregnancy and women's health; Urinary and reproductive; Immune system; Hormones; Nutrition and metabolism; Infections

US protection

US protection ended in 2023.

US protection ended in 2023, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Bristol Myers Squibb. The date is computed, not published.

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.

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Targets

GeneProteinUniProt
CD80T-lymphocyte activation antigen CD80P33681
CD86T-lymphocyte activation antigen CD86P42081

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated9321
Phase 14310
Phase 2301865
Phase 35220
Phase 4151012
All trials63

Who has held its approvals

CompanyRoleYears
Bristol Myers SquibbApplicant and Lead sponsor of trials2011 to now