efgartigimod alfa-fcab (Vyvgart)
efgartigimod alfa-fcab is an FDA-licensed reference biologic from Argenx BV. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Vyvgart efgartigimod alfa-fcab
Argenx BV
- Approved
- Dec 17, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for efgartigimod alfa-fcab, in chronological order.
Reference approval
Approval date of the reference efgartigimod alfa-fcab product.
4 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 7 mo
Frequently asked questions
Are there biosimilars approved for efgartigimod alfa-fcab (Vyvgart)?
No 351(k) biosimilars or interchangeable biosimilars referencing efgartigimod alfa-fcab are listed in the FDA Purple Book yet.
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