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
Molecular structure
Experimental 3D structure for lanadelumab-flyo from the RCSB Protein Data Bank (PDB 4OGY).
Interactive biological assembly from PDB entry 4OGY. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
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 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 7 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.