Purple Book product · Reference 351(a)
Octagam
Immune Globulin Intravenous (Human)
Mar 26, 2007
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 26, 2007
19 yr 7 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 15, 2028
in 2 yr
Pharmaceutical detail
Strength
5% 25G
Dosage form
Injection
Route
Intravenous
Presentation
Single-Use Bottle
Center
CBER
License number
1646
Product number
005
Submission type
Supplement
Supplement number
124
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.
8 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
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Octagam have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Octagam are listed in the FDA Purple Book yet.
What is Octagam's BLA number?
Octagam is licensed under BLA 125062, held by Octapharma Pharmazeutika Produktionsges.m.b.H..
When was Octagam approved by the FDA?
Octagam was approved by the FDA on Mar 26, 2007.
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.
