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FDA Purple Book · Reference family

obiltoxaximab (Anthim)

obiltoxaximab is an FDA-licensed reference biologic from Elusys Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2016

Reference approved

Reference product

351(a)BLA 125509

Anthim obiltoxaximab

Elusys Therapeutics, Inc.

Approved
Mar 18, 2016
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for obiltoxaximab, in chronological order.

  1. Reference approval

    Approval date of the reference obiltoxaximab product.

    10 yr 4 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    3 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for obiltoxaximab (Anthim)?

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

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