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FDA Purple Book · Reference family

zenocutuzumab-zbco (Bizengri)

zenocutuzumab-zbco is an FDA-licensed reference biologic from Merus NV. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2024

Reference approved

Reference product

351(a)BLA 761352

Bizengri zenocutuzumab-zbco

Merus NV

Approved
Dec 04, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference zenocutuzumab-zbco product.

    1 yr 6 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 5 yr 7 mo

Frequently asked questions

Are there biosimilars approved for zenocutuzumab-zbco (Bizengri)?

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

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