Purple Book product · Biosimilar 351(k)
Alymsys
bevacizumab-maly
Apr 13, 2022
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.
Apr 13, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Strength
100MG/4ML (25MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2241
Product number
001
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 Alymsys's patents expire?
The FDA Purple Book lists 22 published patents for Alymsys, 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 Alymsys a biosimilar?
Yes. Alymsys is a Biosimilar 351(k) referencing bevacizumab, licensed under a 351(k) BLA.
Is Alymsys interchangeable?
Alymsys 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 Alymsys's BLA number?
Alymsys is licensed under BLA 761231, held by Amneal Pharmaceuticals LLC.
When was Alymsys approved by the FDA?
Alymsys was approved by the FDA on Apr 13, 2022.
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.
