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FDA Purple Book · Reference family

ramucirumab (Cyramza)

ramucirumab 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

2014

Reference approved

Reference product

351(a)BLA 125477

Cyramza ramucirumab

Eli Lilly and Company

Approved
Apr 21, 2014
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference ramucirumab product.

    12 yr 3 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    22 d ago

Frequently asked questions

Are there biosimilars approved for ramucirumab (Cyramza)?

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

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