ivacaftor Oral Tablet

Brand(s)
Kalydeco
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vertex Pharmaceuticals Incorporated (2015-03-18)
Oldest Current Product
2012-01-31
License(s)
NDA
RxNORM
ORAL TABLET\IVACAFTOR
FDAOB
ORAL\TABLET\IVACAFTOR
SPL Active
ORAL\TABLET, FILM COATED\IVACAFTOR
SPL Moiety
ORAL\TABLET, FILM COATED\IVACAFTOR

product(s) by strength(s)

ivacaftor 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1511670200KalydecoNDAVertex Pharmaceuticals Incorporated2012-01-31IVACAFTORORALTABLET, FILM COATEDNDA2031880ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203188KALYDECOVERTEX PHARMACEUTICALS INC2012-01-31p8324242, METHOD OF TREATING CYSTIC FIBROSIS
p8410274, SUBSTANCE
p7495103, SUBSTANCE
p8754224, SUBSTANCE
p8354427, METHOD OF TREATING CYSTIC FIBROSIS
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE [2017-12-30]
NEW CHEMICAL ENTITY [2017-01-31]
ORPHAN DRUG EXCLUSIVITY [2019-01-31]
NDA203188_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203188_001RXIVACAFTOR (150MG)ORALTABLETTrue2012-01-31KALYDECO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7495103 (view patent)2027-05-20NDA203188, NDA206038, NDA207925ivacaftor Oral Granules
ivacaftor / lumacaftor Oral Tablet
2p8324242 (view patent)2027-04-18NDA203188, NDA206038, NDA207925ivacaftor Oral Granules
ivacaftor / lumacaftor Oral Tablet
3p8354427 (view patent)2026-07-06NDA203188, NDA207925ivacaftor Oral Granules
4p8410274 (view patent)2026-12-28NDA203188, NDA206038, NDA207925ivacaftor Oral Granules
ivacaftor / lumacaftor Oral Tablet
5p8754224 (view patent)2026-12-28NDA203188, NDA206038, NDA207925ivacaftor Oral Granules
ivacaftor / lumacaftor Oral Tablet

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, MANUFACTURE2015-03-1812511670200, 511670300, 511670400ivacaftor Oral Granules

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