imiglucerase (Cerezyme)
imiglucerase is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1994
Reference approved
Reference product
Cerezyme imiglucerase
Genzyme Corporation
- Approved
- May 23, 1994
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for imiglucerase, in chronological order.
Reference approval
Approval date of the reference imiglucerase product.
32 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
25 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for imiglucerase (Cerezyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing imiglucerase are listed in the FDA Purple Book yet.
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