Purple Book product · Reference 351(a)
Sucraid
sacrosidase
May 25, 2022
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 09, 2005
21 yr 7 mo ago
Approval
Approval date of this BLA submission.
May 25, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Strength
17,000IU/2ML (8,500IU/ML)
Dosage form
Solution For Oral
Route
Oral
Presentation
Not listed
Center
CDER
License number
2195
Product number
002
Submission type
Supplement
Supplement number
27
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
1 additional BLA record for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Sucraid have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Sucraid are listed in the FDA Purple Book yet.
What is Sucraid's BLA number?
Sucraid is licensed under BLA 20772, held by QOL Medical, LLC.
When was Sucraid approved by the FDA?
Sucraid was approved by the FDA on May 25, 2022.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
