FDA Purple Book · Reference family
nirsevimab-alip (Beyfortus)
nirsevimab-alip is an FDA-licensed reference biologic from Sanofi Vaccines US Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
351(a)BLA 761328
Beyfortus nirsevimab-alip
Sanofi Vaccines US Inc.
- Approved
- Jul 17, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for nirsevimab-alip, in chronological order.
Reference approval
Approval date of the reference nirsevimab-alip product.
2 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for nirsevimab-alip (Beyfortus)?
No 351(k) biosimilars or interchangeable biosimilars referencing nirsevimab-alip are listed in the FDA Purple Book yet.
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