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FDA Purple Book · Reference family

olaratumab (Lartruvo)

olaratumab 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

2016

Reference approved

Reference product

351(a)BLA 761038

Lartruvo olaratumab

Eli Lilly and Company

Approved
Oct 19, 2016
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for olaratumab, in chronological order.

  1. Reference approval

    Approval date of the reference olaratumab product.

    9 yr 9 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    6 yr 4 mo ago

Frequently asked questions

Are there biosimilars approved for olaratumab (Lartruvo)?

No 351(k) biosimilars or interchangeable biosimilars referencing olaratumab are listed in the FDA Purple Book yet.

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