insulin isophane human (Humulin N)
insulin isophane human is an FDA-licensed reference biologic from Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1982
Reference approved
Reference product
Humulin N insulin isophane human
Eli Lilly and Company
- Approved
- Oct 28, 1982
- Marketing
- OTC
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin isophane human, in chronological order.
Reference approval
Approval date of the reference insulin isophane human product.
44 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for insulin isophane human (Humulin N)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin isophane human are listed in the FDA Purple Book yet.
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