Purple Book product · Interchangeable
Byooviz
ranibizumab-nuna
Sep 17, 2021
Approved
Interchangeable
License type
Rx
Marketing
11
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Sep 17, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Strength
10MG/ML
Dosage form
Injection
Route
Intravitreal
Presentation
Single-Dose Vial
Center
CDER
License number
2046
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ranibizumab (Lucentis)
Patent list (11)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,716,602 | Nov 01, 2021 | 4 yr 9 mo ago | FDA |
| 6,828,121 | Jul 08, 2022 | 4 yr 1 mo ago | FDA |
| 9,688,775 | Dec 31, 2022 | 3 yr 7 mo ago | FDA |
| 6,921,659 | Oct 17, 2023 | 2 yr 10 mo ago | FDA |
| 8,383,773 | Dec 13, 2023 | 2 yr 8 mo ago | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr | FDA |
| 10,421,984 | Sep 19, 2033 | in 7 yr 3 mo | FDA |
| 9,765,379 | Mar 10, 2034 | in 7 yr 9 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,112,994 | Nov 05, 2035 | in 9 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 Byooviz's patents expire?
The FDA Purple Book lists 11 published patents for Byooviz, with the last listed patent expiring Nov 05, 2035. Every patent below links to its FDA source record so you can verify the expiration date.
Is Byooviz a biosimilar?
Yes. Byooviz is a Interchangeable referencing ranibizumab, licensed under a 351(k) BLA.
Is Byooviz interchangeable?
Yes. Byooviz 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 Byooviz's BLA number?
Byooviz is licensed under BLA 761202, held by Samsung Bioepis Co., Ltd..
When was Byooviz approved by the FDA?
Byooviz was approved by the FDA on Sep 17, 2021.
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.
