Antihemophilic Factor (Recombinant), PEGylated (Adynovate)
Antihemophilic Factor (Recombinant), PEGylated is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Adynovate Antihemophilic Factor (Recombinant), PEGylated
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Nov 13, 2015
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), PEGylated, in chronological order.
Reference approval
Approval date of the reference Antihemophilic Factor (Recombinant), PEGylated product.
10 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Antihemophilic Factor (Recombinant), PEGylated (Adynovate)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), PEGylated are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.