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FDA Purple Book · Reference family

datopotamab deruxtecan-dlnk (Datroway)

datopotamab deruxtecan-dlnk is an FDA-licensed reference biologic from Daiichi Sankyo, Inc. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 761394

Datroway datopotamab deruxtecan-dlnk

Daiichi Sankyo, Inc

Approved
Jan 17, 2025
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for datopotamab deruxtecan-dlnk, in chronological order.

  1. Reference approval

    Approval date of the reference datopotamab deruxtecan-dlnk product.

    1 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for datopotamab deruxtecan-dlnk (Datroway)?

No 351(k) biosimilars or interchangeable biosimilars referencing datopotamab deruxtecan-dlnk are listed in the FDA Purple Book yet.

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