Purple Book product · Reference 351(a)

Evkeeza

evinacumab-dgnb

351(a)BLA 761181RxLicensed Regeneron Pharmaceuticals, Inc.

View evinacumab-dgnb family Label PDF Open on FDA Purple Book

Feb 11, 2021

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Evkeeza (evinacumab-dgnb) is Regeneron Pharmaceuticals, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2021. No biosimilars referencing Evkeeza are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Feb 11, 2021
5 yr 6 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 21, 2030
in 3 yr 9 mo

Pharmaceutical detail

Strength

1,200MG/8ML (150MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1760

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

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.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Evkeeza have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Evkeeza are listed in the FDA Purple Book yet.

What is Evkeeza's BLA number?

Evkeeza is licensed under BLA 761181, held by Regeneron Pharmaceuticals, Inc..

When was Evkeeza approved by the FDA?

Evkeeza was approved by the FDA on Feb 11, 2021.

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