Purple Book reference family · 351(a) biologic
aducanumab-avwa (Aduhelm)
aducanumab-avwa is an FDA-licensed reference biologic from Biogen Inc..
351(a) biologicBLA 761178 Biogen Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021
Reference product
Originator biologic
351(a)BLA 761178
Aduhelm aducanumab-avwa
Biogen Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
RCSB Protein Data Bank
Experimental 3D structure for aducanumab-avwa from the RCSB Protein Data Bank (PDB 6CNR).

Interactive biological assembly from PDB entry 6CNR. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference aducanumab-avwa product.
5 yr 4 mo ago
aducanumab-avwa: 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 aducanumab-avwa.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

