lanadelumab-flyo (Takhzyro)
lanadelumab-flyo is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
Takhzyro lanadelumab-flyo
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Feb 08, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lanadelumab-flyo, in chronological order.
Reference approval
Approval date of the reference lanadelumab-flyo product.
4 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 9 mo
Frequently asked questions
Are there biosimilars approved for lanadelumab-flyo (Takhzyro)?
No 351(k) biosimilars or interchangeable biosimilars referencing lanadelumab-flyo are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.