Otezla
(Apremilast)ApprovedSmall molecule
AmgenApremilast is used to treat inflammatory skin conditions like psoriasis and psoriatic arthritis, as well as behçet's disease. It works by reducing inflammation and immune system overactivity that causes these conditions.[2] Otezla is currently approved and in use across 41 indications[4].[1]
Otezla is one of 681 small molecule programs targeting Oral Lichen Planus. It is currently in Approved.
41
Indications
127
Total Trials
22
Active Trials
680
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
11
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 40 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Otezla
AmgenApproved
Spikevax
ModernaPreclinical
Bnt162b2
BioNTechPreclinical
Singulair
AstraZenecaPreclinical
Rayaldee
OOrganon and Co
Preclinical
Aquasol E
NNational Eye Institute (NEI)
Preclinical
Glucocorticoid
AbbViePreclinical
Statins
SanofiPreclinical
HB-Admscs
HHope Biosciences Research Foundation
Preclinical
Olokizumab
UCBPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Psoriasis44 trials
Show 41 more trials
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Withdrawn·—·Phase 2·NCT01200264
Psoriatic Arthritis20 trials
Show 17 more trials
Adult4 trials
Alcohol Use Disorder3 trials
Human Laboratory Study of Apremilast for Alcohol Use Disorder
Not yet recruiting·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT07325266·100 enrolled
Palmoplantar Pustulosis3 trials
40 more indications
Atopic Dermatitis3 trials
Efficacy and Safety3 trials
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
Completed·—·Phase 2·NCT04161456·1 enrolled
AIN2 trials
Vitiligo2 trials
Dermatomyositis2 trials
COVID-192 trials
Alopecia Areata2 trials
Lichen Planus2 trials
Oral Lichen Planus2 trials
Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
Completed·—·Phase 4·NCT06260904·64 enrolled
Rheumatoid Arthritis2 trials
Pneumonia1 trial
Osteoarthritis1 trial
Efficacy1 trial
Hidradenitis Suppurativa1 trial
Methotrexate1 trial
Interaction1 trial
Oral ulcer1 trial
Cicatricial Alopecia1 trial
Arthritis1 trial
Apremilast Therapy for Acute Gouty Arthritis
Withdrawn·—·Phase 2·NCT00997581
Nummular Eczema1 trial
Alopecia1 trial
Recurrent aphthous stomatitis1 trial
Tics1 trial
Ankylosing Spondylitis1 trial
Oral1 trial
Unspecified2 trials
Regulatory
FDA Approval Timeline[5]
Mar 21, 2014
OTEZLA
NDA NDA205437
Aug 29, 2025
OTEZLA XR
NDA NDA210745
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Otezla drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Apremilast. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Otezla. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Patent Landscape[6]
Patent Cliff
Feb 16, 2028
Earliest patent expiration — generic entry possible after this date
Patent #Expires
7427638Feb 16, 2028
7427638*PEDAug 16, 2028
12576034Nov 30, 2033
10092541May 29, 2034
9872854May 29, 2034
6 more patents
12576034*PEDMay 30, 2034
9872854*PEDNov 29, 2034
10092541*PEDNov 29, 2034
11969409May 27, 2042
12427136May 27, 2042
11752129May 27, 2042