beremagene geperpavec-svdt (VYJUVEK)
beremagene geperpavec-svdt is an FDA-licensed reference biologic from Krystal Biotech, Inc.. 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
VYJUVEK beremagene geperpavec-svdt
Krystal Biotech, Inc.
- Approved
- May 19, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for beremagene geperpavec-svdt, in chronological order.
Reference approval
Approval date of the reference beremagene geperpavec-svdt product.
3 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr
Frequently asked questions
Are there biosimilars approved for beremagene geperpavec-svdt (VYJUVEK)?
No 351(k) biosimilars or interchangeable biosimilars referencing beremagene geperpavec-svdt are listed in the FDA Purple Book yet.
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