burosumab-twza (Crysvita)
burosumab-twza is an FDA-licensed reference biologic from Kyowa Kirin, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Crysvita burosumab-twza
Kyowa Kirin, Inc.
- Approved
- Apr 17, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for burosumab-twza from the RCSB Protein Data Bank (PDB 7VEN).
Interactive biological assembly from PDB entry 7VEN. 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 burosumab-twza, in chronological order.
Reference approval
Approval date of the reference burosumab-twza product.
8 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 mo
Frequently asked questions
Are there biosimilars approved for burosumab-twza (Crysvita)?
No 351(k) biosimilars or interchangeable biosimilars referencing burosumab-twza 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.