Purple Book product · Reference 351(a)

Soliris

eculizumab

351(a)BLA 125166RxLicensed Alexion Pharmaceuticals, Inc.

View eculizumab family Label PDF Open on FDA Purple Book

Mar 16, 2007

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Soliris (eculizumab) is Alexion Pharmaceuticals, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2007. 2 approved follow-on biologics reference Soliris (Bkemv and Epysqli).

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

Key dates

Approval
Approval date of this BLA submission.
Mar 16, 2007
19 yr 7 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 28, 2032
in 5 yr 8 mo

Pharmaceutical detail

Strength

300MG/30ML (10MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1743

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

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

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 Soliris have approved biosimilars?

Yes. 2 approved follow-on biologics reference Soliris in the Purple Book: Bkemv and Epysqli.

What is Soliris's BLA number?

Soliris is licensed under BLA 125166, held by Alexion Pharmaceuticals, Inc..

When was Soliris approved by the FDA?

Soliris was approved by the FDA on Mar 16, 2007.

Related FDA reference tools

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

Book a Demo