Purple Book product · Reference 351(a)

Enbrel

etanercept

351(a)BLA 103795RxLicensed Immunex Corporation

View etanercept family Label PDF Open on FDA Purple Book

Feb 01, 2007

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Enbrel (etanercept) is Immunex Corporation's FDA-licensed reference biologic, approved under a 351(a) BLA in 2007. 4 approved follow-on biologics reference Enbrel (Erelzi, Erelzi Sensoready, Enbrel Mini, and Eticovo).

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 27, 2006
20 yr 5 mo ago
Approval
Approval date of this BLA submission.
Feb 01, 2007
19 yr 9 mo ago
Today

Pharmaceutical detail

Strength

25MG/0.5ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1132

Product number

004

Submission type

Supplement

Supplement number

5322

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

5 additional BLA records 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

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Change history

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

Frequently asked questions

Does Enbrel have approved biosimilars?

Yes. 4 approved follow-on biologics reference Enbrel in the Purple Book: Erelzi, Erelzi Sensoready, Enbrel Mini, and Eticovo.

What is Enbrel's BLA number?

Enbrel is licensed under BLA 103795, held by Immunex Corporation.

When was Enbrel approved by the FDA?

Enbrel was approved by the FDA on Feb 01, 2007.

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