lomitapide Oral Capsule

Brand(s)
Juxtapid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aegerion Pharmaceuticals, Inc. (2015-08-26)
Oldest Current Product
2013-01-03
License(s)
NDA
RxNORM
ORAL CAPSULE\LOMITAPIDE
FDAOB
ORAL\CAPSULE\LOMITAPIDE MESYLATE
SPL Active
ORAL\CAPSULE\LOMITAPIDE MESYLATE
SPL Moiety
ORAL\CAPSULE\LOMITAPIDE

product(s) by strength(s)

lomitapide 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310110JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

lomitapide 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310120JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

lomitapide 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310130JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

lomitapide 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310140JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

lomitapide 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310105JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

lomitapide 60 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764310160JuxtapidNDAAegerion Pharmaceuticals, Inc.2013-01-03LOMITAPIDE MESYLATEORALCAPSULENDA203858e4c45bb5-15f4-437e-ab98-a649b3676d14

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203858JUXTAPIDAEGERION PHARMACEUTICALS INC2012-12-21p5712279, TREATMENT OF HYPERCHOLESTEROLEMIA
p7932268, A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
p8618135, A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
p5739135, TREATMENT OF HYPERCHOLESTEROLEMIA
p6492365, TREATMENT OF HYPERCHOLESTEROLEMIA BY DECREASING THE AMOUNT OR ACTIVITY OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
ORPHAN DRUG EXCLUSIVITY [2019-12-21]
NEW CHEMICAL ENTITY [2017-12-21]
NDA203858_001, NDA203858_002, NDA203858_003, NDA203858_004, NDA203858_005, NDA203858_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203858_001RXLOMITAPIDE MESYLATE (EQ 5MG BASE)ORALCAPSULEFalse2012-12-21JUXTAPID
2NDA203858_002RXLOMITAPIDE MESYLATE (EQ 10MG BASE)ORALCAPSULEFalse2012-12-21JUXTAPID
3NDA203858_003RXLOMITAPIDE MESYLATE (EQ 20MG BASE)ORALCAPSULETrue2012-12-21JUXTAPID
4NDA203858_004RXLOMITAPIDE MESYLATE (EQ 30MG BASE)ORALCAPSULEFalse2015-04-23JUXTAPID
5NDA203858_005RXLOMITAPIDE MESYLATE (EQ 40MG BASE)ORALCAPSULEFalse2015-04-23JUXTAPID
6NDA203858_006RXLOMITAPIDE MESYLATE (EQ 60MG BASE)ORALCAPSULEFalse2015-04-23JUXTAPID

patent(s)

#idexpiration dateapplication(s)
1p5712279 (view patent)2016-02-21NDA203858
2p5739135 (view patent)2015-04-14NDA203858
3p6492365 (view patent)2019-12-10NDA203858
4p7932268 (view patent)2027-08-19NDA203858
5p8618135 (view patent)2025-03-07NDA203858

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e4c45bb5-15f4-437e-ab98-a649b3676d14 (view SPL)These highlights do not include all the information needed to use JUXTAPID safely and effectively. See full prescribing information for JUXTAPID. JUXTAPID (lomitapide) capsules, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionAegerion Pharmaceuticals, Inc.2015-08-2612764310105, 764310110, 764310120, 764310130, 764310140, 764310160

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