FDA Purple Book · Reference family
taliglucerase alfa (Elelyso)
taliglucerase alfa is an FDA-licensed reference biologic from Pfizer Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2012
Reference approved
Reference product
351(a)BLA 022458
Elelyso taliglucerase alfa
Pfizer Inc.
- Approved
- May 01, 2012
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for taliglucerase alfa, in chronological order.
Reference approval
Approval date of the reference taliglucerase alfa product.
14 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for taliglucerase alfa (Elelyso)?
No 351(k) biosimilars or interchangeable biosimilars referencing taliglucerase alfa are listed in the FDA Purple Book yet.
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