Purple Book product · Biosimilar 351(k)
Avzivi
bevacizumab-tnjn
Dec 06, 2023
Approved
Biosimilar 351(k)
License type
Rx
Marketing
22
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Dec 06, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Strength
400MG/16ML (25MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2218
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of bevacizumab (Avastin)
Patent list (22)
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,795,672 | May 28, 2024 | 2 yr 2 mo ago | FDA |
| 7,485,704 | Mar 08, 2025 | 1 yr 5 mo ago | FDA |
| 10,906,986 | Jul 08, 2028 | in 2 yr | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr | FDA |
| 8,460,895 | Aug 08, 2029 | in 3 yr 1 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 1 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 1 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 6 mo | FDA |
| 10,011,856 | May 26, 2031 | in 4 yr 11 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 2 mo | FDA |
| 10,704,071 | Aug 18, 2031 | in 5 yr 2 mo | FDA |
| 9,487,809 | Jan 14, 2032 | in 5 yr 7 mo | FDA |
| 10,513,697 | Sep 17, 2032 | in 6 yr 3 mo | FDA |
| 10,906,934 | Oct 12, 2033 | in 7 yr 4 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 9,441,035 | Apr 23, 2034 | in 7 yr 11 mo | FDA |
| 10,274,466 | Jul 11, 2035 | in 9 yr 1 mo | FDA |
| 10,208,355 | Jul 14, 2035 | in 9 yr 1 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 2 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 Avzivi's patents expire?
The FDA Purple Book lists 22 published patents for Avzivi, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.
Is Avzivi a biosimilar?
Yes. Avzivi is a Biosimilar 351(k) referencing bevacizumab, licensed under a 351(k) BLA.
Is Avzivi interchangeable?
Avzivi is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.
What is Avzivi's BLA number?
Avzivi is licensed under BLA 761198, held by Bio-Thera Solutions, Ltd..
When was Avzivi approved by the FDA?
Avzivi was approved by the FDA on Dec 06, 2023.
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.
