Purple Book product · Reference 351(a)
Kymriah
tisagenlecleucel
Aug 30, 2017
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Aug 30, 2017
9 yr ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 27, 2029
in 3 yr 5 mo
Pharmaceutical detail
Strength
0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS
Dosage form
Injection
Route
Intravenous
Presentation
Bag
Center
CBER
License number
1244
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 Kymriah have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Kymriah are listed in the FDA Purple Book yet.
What is Kymriah's BLA number?
Kymriah is licensed under BLA 125646, held by Novartis Pharmaceuticals Corporation.
When was Kymriah approved by the FDA?
Kymriah was approved by the FDA on Aug 30, 2017.
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.
