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FDA Purple Book · Reference family

atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb)

atoltivimab, maftivimab, and odesivimab-ebgn is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2020

Reference approved

Reference product

351(a)BLA 761169

Inmazeb atoltivimab, maftivimab, and odesivimab-ebgn

Regeneron Pharmaceuticals, Inc.

Approved
Oct 14, 2020
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for atoltivimab, maftivimab, and odesivimab-ebgn, in chronological order.

  1. Reference approval

    Approval date of the reference atoltivimab, maftivimab, and odesivimab-ebgn product.

    5 yr 9 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr 5 mo

Frequently asked questions

Are there biosimilars approved for atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb)?

No 351(k) biosimilars or interchangeable biosimilars referencing atoltivimab, maftivimab, and odesivimab-ebgn are listed in the FDA Purple Book yet.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

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