Drug

Ipilimumab

As of the edition of 20 October 2026, Ipilimumab is an antibody: marketed, first approved in 2011 (US); acts on CTLA4; US protection ends in 2027.

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

The drug

Status
Marketed; latest approval 2015
Kind
Antibody
Brand name
Yervoy
First approved
25 March 2011 (US)
Approvals on record
15 in 5 regions
Holder of the most recent approval
Bristol Myers Squibb
Registered trials
774, 145 stopped early
Disease areas
Cancer; Skin and connective tissue; Urinary and reproductive; Lungs and airways; Pregnancy and women's health; Digestive system

US protection

US protection ends in 2027.

The orphan exclusivity ends in 2027 (it covers one use only). The application that gives this date is held by Bristol Myers Squibb.

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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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 Ipilimumab.

Target

GeneProteinUniProt
CTLA4Cytotoxic T-lymphocyte protein 4P16410

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated331891
Phase 1204974850
Phase 246518815991
Phase 36737233
Phase 45320
All trials774

Who has held its approvals

CompanyRoleYears
Bristol Myers SquibbApplicant and Lead sponsor of trials2003 to now