ivacaftor / lumacaftor Oral Tablet

Brand(s)
ORKAMBI
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vertex Pharmaceuticals Incorporated (2015-06-29)
Oldest Current Product
2015-07-06
License(s)
NDA
RxNORM
ORAL TABLET\IVACAFTOR:LUMACAFTOR
FDAOB
ORAL\TABLET\IVACAFTOR: LUMACAFTOR
SPL Active
ORAL\TABLET, FILM COATED\IVACAFTOR: LUMACAFTOR
SPL Moiety
ORAL\TABLET, FILM COATED\IVACAFTOR: LUMACAFTOR

product(s) by strength(s)

ivacaftor 125 mg / lumacaftor 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1511670809ORKAMBINDAVertex Pharmaceuticals Incorporated2015-07-06IVACAFTOR, LUMACAFTORORALTABLET, FILM COATEDNDA2060383fc1c40e-cfac-47a1-9e1a-61ead3570600

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206038ORKAMBIVERTEX PHARMACEUTICALS INC2015-07-02p7495103, SUBSTANCE
p8716338, METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE., SUBSTANCE
p8741933, METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
p8507534, SUBSTANCE
p8846718, METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
p8653103, SUBSTANCE
p8324242, METHOD OF TREATING CYSTIC FIBROSIS
p8410274, SUBSTANCE
p8754224, SUBSTANCE
p8993600, SUBSTANCE
NEW CHEMICAL ENTITY [2020-07-02]
ORPHAN DRUG EXCLUSIVITY [2022-07-02]
NDA206038_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206038_001RXLUMACAFTOR (200MG), IVACAFTOR (125MG)ORALTABLETTrue2015-07-02ORKAMBI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7495103 (view patent)2027-05-20NDA206038, NDA203188, NDA207925ivacaftor Oral Tablet
ivacaftor Oral Granules
2p8324242 (view patent)2027-04-18NDA206038, NDA203188, NDA207925ivacaftor Oral Tablet
ivacaftor Oral Granules
3p8410274 (view patent)2026-12-28NDA206038, NDA203188, NDA207925ivacaftor Oral Tablet
ivacaftor Oral Granules
4p8507534 (view patent)2030-09-20NDA206038
5p8653103 (view patent)2028-12-04NDA206038
6p8716338 (view patent)2026-11-08NDA206038
7p8741933 (view patent)2026-11-08NDA206038
8p8754224 (view patent)2026-12-28NDA206038, NDA203188, NDA207925ivacaftor Oral Tablet
ivacaftor Oral Granules
9p8846718 (view patent)2028-12-04NDA206038
10p8993600 (view patent)2030-12-11NDA206038

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13fc1c40e-cfac-47a1-9e1a-61ead3570600 (view SPL)These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI (lumacaftor/ivacaftor) tablets, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionVertex Pharmaceuticals IncorporatedANALYSIS, MANUFACTURE2015-06-291511670809

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