FDA Purple Book · Reference family
insulin human (Afrezza)
insulin human is an FDA-licensed reference biologic from Mannkind Corporation. 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
351(a)BLA 022472
Afrezza insulin human
Mannkind Corporation
- Approved
- Apr 17, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin human, in chronological order.
Reference approval
Approval date of the reference insulin human product.
11 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for insulin human (Afrezza)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin human are listed in the FDA Purple Book yet.
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