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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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2008

Reference approved

Reference product

351(a)BLA 021810

Novolog Mix 50/50 insulin aspart protamine and insulin aspart

Novo Nordisk Inc.

Approved
Aug 26, 2008
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for insulin aspart protamine and insulin aspart, in chronological order.

  1. Reference approval

    Approval date of the reference insulin aspart protamine and insulin aspart product.

    18 yr ago

Frequently asked questions

Are there biosimilars approved for insulin aspart protamine and insulin aspart (Novolog Mix 50/50)?

No 351(k) biosimilars or interchangeable biosimilars referencing insulin aspart protamine and insulin aspart are listed in the FDA Purple Book yet.

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