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
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 10 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.
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