emapalumab-lzsg (Gamifant)
emapalumab-lzsg is an FDA-licensed reference biologic from Swedish Orphan Biovitrum AB (publ). 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
Gamifant emapalumab-lzsg
Swedish Orphan Biovitrum AB (publ)
- Approved
- Jun 07, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for emapalumab-lzsg, in chronological order.
Reference approval
Approval date of the reference emapalumab-lzsg product.
3 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
6 mo ago
Frequently asked questions
Are there biosimilars approved for emapalumab-lzsg (Gamifant)?
No 351(k) biosimilars or interchangeable biosimilars referencing emapalumab-lzsg are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.