vestronidase alfa-vjbk (Mepsevii)
vestronidase alfa-vjbk is an FDA-licensed reference biologic from Ultragenyx Pharamceutical Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Mepsevii vestronidase alfa-vjbk
Ultragenyx Pharamceutical Inc.
- Approved
- Nov 15, 2017
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for vestronidase alfa-vjbk, in chronological order.
Reference approval
Approval date of the reference vestronidase alfa-vjbk product.
8 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for vestronidase alfa-vjbk (Mepsevii)?
No 351(k) biosimilars or interchangeable biosimilars referencing vestronidase alfa-vjbk are listed in the FDA Purple Book yet.
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