Purple Book product · Reference 351(a)
Spevigo
spesolimab-sbzo
May 28, 2025
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.
May 28, 2025
1 yr 2 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 18, 2031
in 4 yr 9 mo
Pharmaceutical detail
Strength
300MG/2ML (150MG/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2169
Product number
003
Submission type
Supplement
Supplement number
4
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.
2 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 Spevigo have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Spevigo are listed in the FDA Purple Book yet.
What is Spevigo's BLA number?
Spevigo is licensed under BLA 761244, held by LEO Pharma A/S.
When was Spevigo approved by the FDA?
Spevigo was approved by the FDA on May 28, 2025.
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.
