Purple Book product · Reference 351(a)
KEBILIDI
eladocagene exuparvovec-tneq
Nov 13, 2024
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 13, 1931
96 yr 1 mo ago
Approval
Approval date of this BLA submission.
Nov 13, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Strength
5.6x10^11VG/ML
Dosage form
Suspension
Route
Intraputaminal
Presentation
Single-Dose Vial
Center
CBER
License number
2168
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does KEBILIDI have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing KEBILIDI are listed in the FDA Purple Book yet.
What is KEBILIDI's BLA number?
KEBILIDI is licensed under BLA 125722, held by PTC Therapeutics.
When was KEBILIDI approved by the FDA?
KEBILIDI was approved by the FDA on Nov 13, 2024.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
