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FDA Purple Book · Reference family

eflapegrastim-xnst (Rolvedon)

eflapegrastim-xnst is an FDA-licensed reference biologic from Assertio Specialty Pharmaceuticals, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2022

Reference approved

Reference product

351(a)BLA 761148

Rolvedon eflapegrastim-xnst

Assertio Specialty Pharmaceuticals, LLC

Approved
Sep 09, 2022
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference eflapegrastim-xnst product.

    3 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for eflapegrastim-xnst (Rolvedon)?

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

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