Purple Book reference family · 351(a) biologic
lecanemab-irmb (Leqembi)
lecanemab-irmb is an FDA-licensed reference biologic from Eisai, Incorporated.
351(a) biologicBLA 761269 Eisai, Incorporated
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 761269
Leqembi lecanemab-irmb
Eisai, Incorporated
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference lecanemab-irmb product.
3 yr 7 mo ago
lecanemab-irmb: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for lecanemab-irmb.
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