FDA Purple Book · Reference family
tezepelumab-ekko (Tezspire)
tezepelumab-ekko is an FDA-licensed reference biologic from AstraZeneca AB. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
351(a)BLA 761224
Tezspire tezepelumab-ekko
AstraZeneca AB
- Approved
- Dec 17, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tezepelumab-ekko, in chronological order.
Reference approval
Approval date of the reference tezepelumab-ekko product.
4 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for tezepelumab-ekko (Tezspire)?
No 351(k) biosimilars or interchangeable biosimilars referencing tezepelumab-ekko are listed in the FDA Purple Book yet.
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