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FDA Purple Book · Reference family

sacrosidase (Sucraid)

sacrosidase is an FDA-licensed reference biologic from QOL Medical, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2022

Reference approved

Reference product

351(a)BLA 020772

Sucraid sacrosidase

QOL Medical, LLC

Approved
May 25, 2022
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    21 yr 5 mo ago

  2. Reference approval

    Approval date of the reference sacrosidase product.

    4 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for sacrosidase (Sucraid)?

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

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