FDA Purple Book · Reference family
lecanemab-irmb (Leqembi)
lecanemab-irmb is an FDA-licensed reference biologic from Eisai, Incorporated. 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 761269
Leqembi lecanemab-irmb
Eisai, Incorporated
- Approved
- Jan 06, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lecanemab-irmb, in chronological order.
Reference approval
Approval date of the reference lecanemab-irmb product.
3 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for lecanemab-irmb (Leqembi)?
No 351(k) biosimilars or interchangeable biosimilars referencing lecanemab-irmb are listed in the FDA Purple Book yet.
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