Purple Book reference family · 351(a) biologic
insulin aspart protamine and insulin aspart (Novolog Mix 50/50)
insulin aspart protamine and insulin aspart is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 021810 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2008
Reference product
Originator biologic
351(a)BLA 021810
Novolog Mix 50/50 insulin aspart protamine and insulin aspart
Novo Nordisk Inc.
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 aspart protamine and insulin aspart product.
18 yr 2 mo ago
insulin aspart protamine and insulin aspart: 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 aspart protamine and insulin aspart.
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