hyaluronidase human (Hylenex recombinant)
hyaluronidase human is an FDA-licensed reference biologic from Halozyme Therapeutics, Inc..
Reference product
Hylenex recombinant hyaluronidase human
Halozyme Therapeutics, Inc.
View full reference-product record- Approved
- 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, with no need to leave the page.
Exclusivity & patent cliffs
Reference approval
Approval date of the reference hyaluronidase human product.
21 yr 1 mo ago
hyaluronidase human: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for hyaluronidase human.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
