FDA Purple Book · Reference family
hyaluronidase (Amphadase)
hyaluronidase is an FDA-licensed reference biologic from Amphastar Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
351(a)BLA 021665
Amphadase hyaluronidase
Amphastar Pharmaceuticals, Inc.
- Approved
- Oct 26, 2004
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for hyaluronidase, in chronological order.
Reference approval
Approval date of the reference hyaluronidase product.
21 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for hyaluronidase (Amphadase)?
No 351(k) biosimilars or interchangeable biosimilars referencing hyaluronidase are listed in the FDA Purple Book yet.
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