Purple Book reference family · 351(a) biologic
taliglucerase alfa (Elelyso)
taliglucerase alfa is an FDA-licensed reference biologic from Pfizer Inc..
351(a) biologicBLA 022458 Pfizer Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2012
Reference product
Originator biologic
351(a)BLA 022458
Elelyso taliglucerase alfa
Pfizer Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference taliglucerase alfa product.
14 yr 5 mo ago
taliglucerase alfa: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for taliglucerase alfa.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
