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FDA Purple Book · Reference family

insulin lispro-aabc (Lyumjev)

insulin lispro-aabc 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

2020

Reference approved

Reference product

351(a)BLA 761109

Lyumjev insulin lispro-aabc

Eli Lilly and Company

Approved
Jun 15, 2020
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference insulin lispro-aabc product.

    6 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for insulin lispro-aabc (Lyumjev)?

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

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