Purple Book product · Reference 351(a)

Ultomiris

ravulizumab-cwvz

351(a)BLA 761108RxLicensed Alexion Pharmaceuticals, Inc.

View ravulizumab-cwvz family Label PDF Open on FDA Purple Book

Oct 09, 2020

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Ultomiris (ravulizumab-cwvz) is Alexion Pharmaceuticals, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2020. No biosimilars referencing Ultomiris 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.
Oct 09, 2020
5 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 07, 2028
in 1 yr 11 mo

Pharmaceutical detail

Strength

1,100MG/11ML (100MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1743

Product number

003

Submission type

Supplement

Supplement number

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.

3 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

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

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

Frequently asked questions

Does Ultomiris have approved biosimilars?

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

What is Ultomiris's BLA number?

Ultomiris is licensed under BLA 761108, held by Alexion Pharmaceuticals, Inc..

When was Ultomiris approved by the FDA?

Ultomiris was approved by the FDA on Oct 09, 2020.

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