Purple Book product · Reference 351(a)

Gamifant

emapalumab-lzsg

351(a)BLA 761107RxLicensed Swedish Orphan Biovitrum AB (publ)

View emapalumab-lzsg family Open on FDA Purple Book

At a glance

Jun 07, 2023

Approved

Reference 351(a)

License type

Marketing

Patents listed

Key dates

Approval
Approval date of this BLA submission.
Jun 07, 2023
3 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 20, 2025
7 mo ago
Today

Pharmaceutical detail

Strength

250MG/10ML (25MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1859

Product number

006

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Taxonomy and ontology

12 terms

center

Center for Drug Evaluation and Research

center · CDER

application pathway

Biologics License Application

blaNumber · BLA

license type

351(a)

blaType · 351(a)

application pathway

Section 351(a) Biologic

blaType · 351(a)

product role

Reference or Standalone Biologic

blaType · Reference product

marketing status

Prescription

marketingStatus · Rx

licensure status

Licensed

licensure · Licensed

route

Intravenous

routeOfAdministration · Intravenous

dosage form

Injection

dosageForm · Injection

source kind

Monthly Download

sourceKind · monthly_download

Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
Food and Drug Administrationsource forMonthly Download
Biologics License Applicationparent ofSection 351(a) Biologic
Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
Section 351(a) Biologicmaps to351(a)
351(a)classifiesReference or Standalone Biologic

Source provenance

Source kind · Monthly download

Checked May 28, 2026

FDA release · April 2026

FDA source FDA source

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo