apremilast Oral Tablet

Brand(s)
Otezla
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Celgene Corporation (2015-06-02)
Oldest Current Product
2014-04-03
License(s)
NDA
RxNORM
ORAL TABLET\APREMILAST
FDAOB
ORAL\TABLET\APREMILAST
SPL Active
ORAL\TABLET, FILM COATED\APREMILAST
SPL Moiety
ORAL\TABLET, FILM COATED\APREMILAST

product(s) by strength(s)

apremilast 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720631OtezlaNDACelgene Corporation2014-04-03APREMILASTORALTABLET, FILM COATEDNDA2054373acf6751-827d-11e2-9e96-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205437OTEZLACELGENE CORP2014-03-21p6020358, USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4, SUBSTANCE
p9018243, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
p7208516, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
p7427638, SUBSTANCE
p6962940, USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
p8802717, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
p7893101, SUBSTANCE
p8455536, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
p7659302, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
NEW CHEMICAL ENTITY [2019-03-21]
TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY [2017-09-23]
NDA205437_001, NDA205437_002, NDA205437_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205437_001RXAPREMILAST (10MG)ORALTABLETFalse2014-03-21OTEZLA
2NDA205437_002RXAPREMILAST (20MG)ORALTABLETFalse2014-03-21OTEZLA
3NDA205437_003RXAPREMILAST (30MG)ORALTABLETTrue2014-03-21OTEZLA

patent(s)

#idexpiration dateapplication(s)
1p6020358 (view patent)2018-10-30NDA205437
2p6962940 (view patent)2023-03-19NDA205437
3p7208516 (view patent)2023-03-19NDA205437
4p7427638 (view patent)2024-11-17NDA205437
5p7659302 (view patent)2023-03-19NDA205437
6p7893101 (view patent)2023-12-09NDA205437
7p8455536 (view patent)2023-03-19NDA205437
8p8802717 (view patent)2023-03-19NDA205437
9p9018243 (view patent)2023-03-19NDA205437

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13acf6751-827d-11e2-9e96-0800200c9a66 (view SPL)These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA (apremilast) tablets, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionCelgene Corporation2015-06-0210595720631, 595720630, 595720632

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