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FDA Purple Book · Reference family

sacituzumab govitecan-hziy (Trodelvy)

sacituzumab govitecan-hziy is an FDA-licensed reference biologic from Gilead Sciences, Inc.. 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 761115

Trodelvy sacituzumab govitecan-hziy

Gilead Sciences, Inc.

Approved
Apr 22, 2020
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for sacituzumab govitecan-hziy, in chronological order.

  1. Reference approval

    Approval date of the reference sacituzumab govitecan-hziy product.

    6 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for sacituzumab govitecan-hziy (Trodelvy)?

No 351(k) biosimilars or interchangeable biosimilars referencing sacituzumab govitecan-hziy are listed in the FDA Purple Book yet.

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