Purple Book reference family · 351(a) biologic
insulin isophane human (Humulin N)
insulin isophane human is an FDA-licensed reference biologic from Eli Lilly and Company.
351(a) biologicBLA 018781 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1982
Reference product
Originator biologic
351(a)BLA 018781
Humulin N insulin isophane human
Eli Lilly and Company
View full reference-product record- Approved
- Marketing
- OTC
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference insulin isophane human product.
44 yr 5 mo ago
insulin isophane human: 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 insulin isophane human.
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