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FDA Purple Book · Reference family

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

0

Biosimilars

0

Interchangeables

0

Listed patents

1999

Reference approved

Reference product

351(a)BLA 021018

Humalog Mix 50/50 insulin lispro protamine and insulin lispro

Eli Lilly and Company

Approved
Dec 22, 1999
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    26 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for insulin lispro protamine and insulin lispro (Humalog Mix 50/50)?

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

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