Purple Book product · Reference 351(a)
Cerezyme
imiglucerase
Sep 22, 1999
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Sep 22, 1999
27 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 23, 2001
25 yr 6 mo ago
Today
Pharmaceutical detail
Strength
400UNITS/VIAL
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1596
Product number
002
Submission type
Supplement
Supplement number
34
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
- v1Jul 02, 2026
Frequently asked questions
Does Cerezyme have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Cerezyme are listed in the FDA Purple Book yet.
What is Cerezyme's BLA number?
Cerezyme is licensed under BLA 20367, held by Genzyme Corporation.
When was Cerezyme approved by the FDA?
Cerezyme was approved by the FDA on Sep 22, 1999.
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.
