pomalidomide Oral Capsule

Brand(s)
Pomalyst
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Celgene Corporation (2015-04-30)
Oldest Current Product
2013-02-18
License(s)
NDA
RxNORM
ORAL CAPSULE\POMALIDOMIDE
FDAOB
ORAL\CAPSULE\POMALIDOMIDE
SPL Active
ORAL\CAPSULE\POMALIDOMIDE
SPL Moiety
ORAL\CAPSULE\POMALIDOMIDE

product(s) by strength(s)

pomalidomide 1 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720501PomalystNDACelgene Corporation2013-02-18POMALIDOMIDEORALCAPSULENDA2040262b25ef01-5c9e-11e1-b86c-0800200c9a66

pomalidomide 2 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720502PomalystNDACelgene Corporation2013-02-18POMALIDOMIDEORALCAPSULENDA2040262b25ef01-5c9e-11e1-b86c-0800200c9a66

pomalidomide 3 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720503PomalystNDACelgene Corporation2013-02-18POMALIDOMIDEORALCAPSULENDA2040262b25ef01-5c9e-11e1-b86c-0800200c9a66

pomalidomide 4 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720504PomalystNDACelgene Corporation2013-02-18POMALIDOMIDEORALCAPSULENDA2040262b25ef01-5c9e-11e1-b86c-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204026POMALYSTCELGENE CORP2013-02-08p8158653, SUBSTANCE
p6476052, USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA, SUBSTANCE
p8828427, SUBSTANCE
p8204763, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p5635517, USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES
p8589188, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p6315720, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p8315886, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p8198262, USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
p8673939, USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
p6561976, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p6561977, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p6316471, USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA, SUBSTANCE
p6908432, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p6755784, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p8626531, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p6045501, USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
p8735428, USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
NEW CHEMICAL ENTITY [2018-02-08]
POMALYST [2018-04-23]
ORPHAN DRUG EXCLUSIVITY [2020-02-08]
NDA204026_001, NDA204026_002, NDA204026_003, NDA204026_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204026_001RXPOMALIDOMIDE (1MG)ORALCAPSULEFalse2013-02-08POMALYST
2NDA204026_002RXPOMALIDOMIDE (2MG)ORALCAPSULEFalse2013-02-08POMALYST
3NDA204026_003RXPOMALIDOMIDE (3MG)ORALCAPSULEFalse2013-02-08POMALYST
4NDA204026_004RXPOMALIDOMIDE (4MG)ORALCAPSULETrue2013-02-08POMALYST

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5635517 (view patent)2019-10-04NDA204026, NDA021880lenalidomide Oral Capsule
2p6045501 (view patent)2018-08-28NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
3p6315720 (view patent)2020-10-23NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
4p6316471 (view patent)2016-08-10NDA204026
5p6476052 (view patent)2016-07-24NDA204026
6p6561976 (view patent)2018-08-28NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
7p6561977 (view patent)2020-10-23NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
8p6755784 (view patent)2020-10-23NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
9p6908432 (view patent)2018-08-28NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
10p8158653 (view patent)2016-08-10NDA204026
11p8198262 (view patent)2024-10-19NDA204026
12p8204763 (view patent)2018-08-28NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
13p8315886 (view patent)2020-10-23NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
14p8589188 (view patent)2018-08-28NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
15p8626531 (view patent)2020-10-23NDA204026, NDA020785, NDA021880lenalidomide Oral Capsule
Thalidomide Oral Capsule
16p8673939 (view patent)2023-05-15NDA204026
17p8735428 (view patent)2023-05-15NDA204026
18p8828427 (view patent)2031-06-21NDA204026

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12b25ef01-5c9e-11e1-b86c-0800200c9a66 (view SPL)These highlights do not include all the information needed to use POMALYST safely and effectively. See full prescribing information for POMALYST. POMALYST (pomalidomide) capsules, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionCelgene Corporation2015-04-307595720501, 595720502, 595720503, 595720504

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