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
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.
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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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.
