eladocagene exuparvovec-tneq (KEBILIDI)
eladocagene exuparvovec-tneq is an FDA-licensed reference biologic from PTC Therapeutics. 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
KEBILIDI eladocagene exuparvovec-tneq
PTC Therapeutics
- Approved
- Nov 13, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for eladocagene exuparvovec-tneq, in chronological order.
Reference approval
Approval date of the reference eladocagene exuparvovec-tneq product.
1 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 6 mo
Frequently asked questions
Are there biosimilars approved for eladocagene exuparvovec-tneq (KEBILIDI)?
No 351(k) biosimilars or interchangeable biosimilars referencing eladocagene exuparvovec-tneq 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.