Skip to content

On this page

Yervoy

ipilimumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Yervoy

Proper name

ipilimumab

Licence type

351(a)

BLA number

125377

Applicant

Bristol-Myers Squibb Company

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
200MG/40ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 25, 2011
50MG/10ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 25, 2011

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 2, 2027

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity