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FDA Purple Book · Reference family

elranatamab-bcmm (Elrexfio)

elranatamab-bcmm is an FDA-licensed reference biologic from Pfizer Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2023

Reference approved

Reference product

351(a)BLA 761345

Elrexfio elranatamab-bcmm

Pfizer Inc.

Approved
Aug 14, 2023
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference elranatamab-bcmm product.

    2 yr 10 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 4 yr 3 mo

Frequently asked questions

Are there biosimilars approved for elranatamab-bcmm (Elrexfio)?

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

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