FDA Purple Book · Reference family
Albumin (Human) (Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5)
Albumin (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1942
Reference approved
Reference product
351(a)BLA 101138
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 Albumin (Human)
Grifols Therapeutics LLC
- Approved
- Oct 21, 1942
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Albumin (Human), in chronological order.
Reference approval
Approval date of the reference Albumin (Human) product.
84 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for Albumin (Human) (Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5)?
No 351(k) biosimilars or interchangeable biosimilars referencing Albumin (Human) are listed in the FDA Purple Book yet.
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