pegunigalsidase alfa-iwxj (Elfabrio)
pegunigalsidase alfa-iwxj is an FDA-licensed reference biologic from Chiesi Farmaceutici S.p.A.. 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
Elfabrio pegunigalsidase alfa-iwxj
Chiesi Farmaceutici S.p.A.
- Approved
- May 17, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegunigalsidase alfa-iwxj, in chronological order.
Reference approval
Approval date of the reference pegunigalsidase alfa-iwxj product.
2 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for pegunigalsidase alfa-iwxj (Elfabrio)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegunigalsidase alfa-iwxj are listed in the FDA Purple Book yet.
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