ivacaftor Oral Granules

Brand(s)
Kalydeco
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vertex Pharmaceuticals Incorporated (2015-03-18)
Oldest Current Product
2015-03-23
License(s)
NDA
RxNORM
ORAL GRANULES\IVACAFTOR
FDAOB
ORAL\GRANULE\IVACAFTOR
SPL Active
ORAL\GRANULE\IVACAFTOR
SPL Moiety
ORAL\GRANULE\IVACAFTOR

product(s) by strength(s)

ivacaftor 50 mg oral granules

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1511670300KalydecoNDAVertex Pharmaceuticals Incorporated2015-03-23IVACAFTORORALGRANULENDA2079250ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25

ivacaftor 75 mg oral granules

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1511670400KalydecoNDAVertex Pharmaceuticals Incorporated2015-03-23IVACAFTORORALGRANULENDA2079250ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA207925KALYDECOVERTEX PHARMACEUTICALS INC2015-03-17p7495103, SUBSTANCE
p8410274, SUBSTANCE
p8354427, METHOD OF TREATING CYSTIC FIBROSIS
p8883206, SUBSTANCE
p8324242, METHOD OF TREATING CYSTIC FIBROSIS
p8754224, SUBSTANCE
NDA207925_001, NDA207925_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207925_001RXIVACAFTOR (50MG/PACKET)ORALGRANULEFalse2015-03-17KALYDECO
2NDA207925_002RXIVACAFTOR (75MG/PACKET)ORALGRANULETrue2015-03-17KALYDECO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7495103 (view patent)2027-05-20NDA207925, NDA203188, NDA206038ivacaftor Oral Tablet
ivacaftor / lumacaftor Oral Tablet
2p8324242 (view patent)2027-04-18NDA207925, NDA203188, NDA206038ivacaftor Oral Tablet
ivacaftor / lumacaftor Oral Tablet
3p8354427 (view patent)2026-07-06NDA207925, NDA203188ivacaftor Oral Tablet
4p8410274 (view patent)2026-12-28NDA207925, NDA203188, NDA206038ivacaftor Oral Tablet
ivacaftor / lumacaftor Oral Tablet
5p8754224 (view patent)2026-12-28NDA207925, NDA203188, NDA206038ivacaftor Oral Tablet
ivacaftor / lumacaftor Oral Tablet
6p8883206 (view patent)2033-02-27NDA207925

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25 (view SPL)These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO (ivacaftor) tablets, for oral useKALYDECO (ivacaftor) oral granulesInitial U.S. Approval: 2012prescriptionHuman PrescriptionVertex Pharmaceuticals IncorporatedANALYSIS, MANUFACTURE2015-03-1812511670300, 511670400, 511670200ivacaftor Oral Tablet

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