Purple Book product · Reference 351(a)
Blincyto
blinatumomab
Dec 03, 2014
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.
Dec 03, 2014
11 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 14, 2031
in 5 yr
Pharmaceutical detail
Strength
35MCG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1080
Product number
001
Submission type
Original
Supplement number
Not listed
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 Blincyto have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Blincyto are listed in the FDA Purple Book yet.
What is Blincyto's BLA number?
Blincyto is licensed under BLA 125557, held by Amgen Inc..
When was Blincyto approved by the FDA?
Blincyto was approved by the FDA on Dec 03, 2014.
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.
