mipomersen Prefilled Syringe

Brand(s)
Kynamro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genzyme Corporation (2015-04-02)
Oldest Current Product
2013-01-29
License(s)
NDA
RxNORM
PREFILLED SYRINGE\MIPOMERSEN
FDAOB
SUBCUTANEOUS\SOLUTION\MIPOMERSEN SODIUM
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\MIPOMERSEN SODIUM
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\MIPOMERSEN

product(s) by strength(s)

1 ml mipomersen sodium 200 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680191KynamroNDAGenzyme Corporation2013-01-29MIPOMERSEN SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA20356834de65be-f110-4000-a0f1-cb00ec98658f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203568KYNAMROGENZYME CORP2013-01-29p7511131
p7407943, ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY LIPOPROTEIN-CHOLESTEROL
p7015315
p6166197
p7101993
p6222025
p6451991
ORPHAN DRUG EXCLUSIVITY [2020-01-29]
NEW CHEMICAL ENTITY [2018-01-29]
NDA203568_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203568_001RXMIPOMERSEN SODIUM (200MG/ML)SUBCUTANEOUSSOLUTIONTrue2013-01-29KYNAMRO

patent(s)

#idexpiration dateapplication(s)
1p6166197 (view patent)2017-12-26NDA203568
2p6222025 (view patent)2015-03-06NDA203568
3p6451991 (view patent)2017-02-11NDA203568
4p7015315 (view patent)2023-03-21NDA203568
5p7101993 (view patent)2023-09-05NDA203568
6p7407943 (view patent)2021-08-01NDA203568
7p7511131 (view patent)2025-12-13NDA203568

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
134de65be-f110-4000-a0f1-cb00ec98658f (view SPL)These highlights do not include all the information needed to use KYNAMRO safely and effectively. See full prescribing information for KYNAMRO. KYNAMRO (mipomersen sodium) InjectionSolution for Subcutaneous InjectionInitial U.S. Approval: 2013prescriptionHuman PrescriptionGenzyme Corporationanalysis, api manufacture, label, manufacture, pack2015-04-024584680191

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