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FDA Purple Book · Reference family

romosozumab-aqqg (Evenity)

romosozumab-aqqg is an FDA-licensed reference biologic from Amgen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2019

Reference approved

Reference product

351(a)BLA 761062

Evenity romosozumab-aqqg

Amgen Inc.

Approved
Apr 09, 2019
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference romosozumab-aqqg product.

    7 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for romosozumab-aqqg (Evenity)?

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

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