Purple Book product · Reference 351(a)

Inmazeb

atoltivimab, maftivimab, and odesivimab-ebgn

351(a)BLA 761169RxLicensed Regeneron Pharmaceuticals, Inc.

View atoltivimab, maftivimab, and odesivimab-ebgn family Label PDF Open on FDA Purple Book

Oct 14, 2020

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) is Regeneron Pharmaceuticals, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2020. No biosimilars referencing Inmazeb 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 14, 2020
5 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 14, 2027
in 1 yr 3 mo

Pharmaceutical detail

Strength

241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1760

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. 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 Inmazeb have approved biosimilars?

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

What is Inmazeb's BLA number?

Inmazeb is licensed under BLA 761169, held by Regeneron Pharmaceuticals, Inc..

When was Inmazeb approved by the FDA?

Inmazeb was approved by the FDA on Oct 14, 2020.

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