Purple Book product · Reference 351(a)
Idelvion
Coagulation Factor IX (Recombinant), Albumin Fusion Protein
Mar 04, 2016
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.
Mar 04, 2016
10 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 04, 2023
3 yr 5 mo ago
Today
Pharmaceutical detail
Strength
1000IU
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
2009
Product number
002
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.
4 additional BLA records for this product (other strengths or presentations) are in the same reference family.
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
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Idelvion have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Idelvion are listed in the FDA Purple Book yet.
What is Idelvion's BLA number?
Idelvion is licensed under BLA 125582, held by CSL Behring Lengnau AG.
When was Idelvion approved by the FDA?
Idelvion was approved by the FDA on Mar 04, 2016.
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.
