Purple Book reference family · 351(a) biologic
benralizumab (Fasenra)
benralizumab is an FDA-licensed reference biologic from AstraZeneca AB.
351(a) biologicBLA 761070 AstraZeneca AB
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 761070
Fasenra benralizumab
AstraZeneca AB
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 benralizumab product.
7 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 1 mo
benralizumab: 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 benralizumab.
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