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insulin degludec and insulin aspart (Ryzodeg 70/30)

insulin degludec 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

2015

Reference approved

Reference product

351(a)BLA 203313

Ryzodeg 70/30 insulin degludec and insulin aspart

Novo Nordisk Inc.

Approved
Sep 25, 2015
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

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

    10 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for insulin degludec and insulin aspart (Ryzodeg 70/30)?

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

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