taliglucerase alfa Injectable Solution

Brand(s)
Elelyso
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-09-05)
Oldest Current Product
2012-05-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\TALIGLUCERASE ALFA
FDAOB
IV (INFUSION)\POWDER\TALIGLUCERASE ALFA\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TALIGLUCERASE ALFA
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TALIGLUCERASE ALFA

product(s) by strength(s)

taliglucerase alfa 40 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690106ElelysoNDAPfizer Labs2012-05-01TALIGLUCERASE ALFAINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA022458fa3cbd5d-677c-4b19-9032-d9182cb69a83

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022458ELELYSOPFIZER INC2012-05-01p8227230, SUBSTANCE
p8741620, SUBSTANCE
p8790641, A METHOD OF CATALYZING THE HYDROLYSIS OF GLUCOCEREBROSIDE TO GLUCOSE AND CERAMIDE./ A METHOD OF TREATING GAUCHER'S DISEASE
NEW CHEMICAL ENTITY [2017-05-01]
NEW PATIENT POPULATION [2017-08-27]
NDA022458_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022458_001RXTALIGLUCERASE ALFA (200 UNITS/VIAL)POWDERTrue2012-05-01ELELYSO

patent(s)

#idexpiration dateapplication(s)
1p8227230 (view patent)2024-02-24NDA022458
2p8741620 (view patent)2024-02-24NDA022458
3p8790641 (view patent)2025-10-18NDA022458

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1fa3cbd5d-677c-4b19-9032-d9182cb69a83 (view SPL)These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO. ELELYSO (taliglucerase alfa) for injection, for intravenous use Initial U.S. Approval: 2012prescriptionHuman PrescriptionPfizer LabsMANUFACTURE, PACK2014-09-059000690106

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII