Purple Book reference family · 351(a) biologic
insulin lispro protamine and insulin lispro (Humalog Mix 50/50)
insulin lispro protamine and insulin lispro is an FDA-licensed reference biologic from Eli Lilly and Company.
351(a) biologicBLA 021018 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1999
Reference product
Originator biologic
351(a)BLA 021018
Humalog Mix 50/50 insulin lispro protamine and insulin lispro
Eli Lilly and Company
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference insulin lispro protamine and insulin lispro product.
27 yr ago
insulin lispro protamine and insulin lispro: 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 lispro protamine and insulin lispro.
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