Purple Book product · Reference 351(a)
Rystiggo
rozanolixizumab-noli
Jun 14, 2024
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.
Jun 14, 2024
2 yr 1 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 26, 2030
in 4 yr
Pharmaceutical detail
Strength
560MG/4ML (140MG/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
1736
Product number
003
Submission type
Supplement
Supplement number
1
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.
3 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
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Rystiggo have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Rystiggo are listed in the FDA Purple Book yet.
What is Rystiggo's BLA number?
Rystiggo is licensed under BLA 761286, held by UCB, Inc..
When was Rystiggo approved by the FDA?
Rystiggo was approved by the FDA on Jun 14, 2024.
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.
