Purple Book reference family · 351(a) biologic
hyaluronidase (Amphadase)
hyaluronidase is an FDA-licensed reference biologic from Amphastar Pharmaceuticals, Inc..
351(a) biologicBLA 021665 Amphastar Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2004
Reference product
Originator biologic
351(a)BLA 021665
Amphadase hyaluronidase
Amphastar Pharmaceuticals, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference hyaluronidase product.
22 yr 1 mo ago
hyaluronidase: 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.
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