Purple Book product · Interchangeable
Selarsdi
ustekinumab-aekn
Apr 16, 2024
Approved
Interchangeable
License type
Rx
Marketing
12
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Apr 16, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Strength
45MG/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2225
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ustekinumab (Stelara)
Patent list (12)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,902,734 | Sep 25, 2023 | 2 yr 10 mo ago | FDA |
| 6,902,734 | Sep 25, 2023 | 2 yr 10 mo ago | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 1 mo | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 1 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 1 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 1 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 9 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 9 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 9 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 9 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 5 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 5 mo | FDA |
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
When do Selarsdi's patents expire?
The FDA Purple Book lists 12 published patents for Selarsdi, with the last listed patent expiring Sep 24, 2039. Every patent below links to its FDA source record so you can verify the expiration date.
Is Selarsdi a biosimilar?
Yes. Selarsdi is a Interchangeable referencing ustekinumab, licensed under a 351(k) BLA.
Is Selarsdi interchangeable?
Yes. Selarsdi carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
What is Selarsdi's BLA number?
Selarsdi is licensed under BLA 761343, held by Alvotech USA Inc..
When was Selarsdi approved by the FDA?
Selarsdi was approved by the FDA on Apr 16, 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.
