hyaluronidase human (Hylenex recombinant)
hyaluronidase human is an FDA-licensed reference biologic from Halozyme Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2005
Reference approved
Reference product
Hylenex recombinant hyaluronidase human
Halozyme Therapeutics, Inc.
- Approved
- Dec 02, 2005
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for hyaluronidase human from the RCSB Protein Data Bank (PDB 9JUB).
Interactive biological assembly from PDB entry 9JUB. 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 hyaluronidase human, in chronological order.
Reference approval
Approval date of the reference hyaluronidase human product.
20 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for hyaluronidase human (Hylenex recombinant)?
No 351(k) biosimilars or interchangeable biosimilars referencing hyaluronidase human 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.