OTEZLA XR

Launch

apremilast

NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
20

Clinical Trials (5)

NCT06122649Phase 3Completed

A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

Started Nov 2023
203 enrolled
Plaque Psoriasis
NCT06088199Phase 3Active Not Recruiting

A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Started Oct 2023
51 enrolled
Plaque Psoriasis
NCT05767047Phase 3Recruiting

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Started Mar 2023
48 enrolled
Behçet's DiseaseJuvenile Psoriatic Arthritis
NCT05565560Phase 3Active Not Recruiting

A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

Started Jan 2023
17 enrolled
Plaque Psoriasis
NCT05744466N/ARecruiting

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Started Sep 2022
1,500 enrolled
Psoriasis

Loss of Exclusivity

LOE Date
May 27, 2042
197 months away
Patent Expiry
May 27, 2042
Exclusivity Expiry
Jan 20, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
7427638
Feb 16, 2028
SubstanceProduct
10092541
May 29, 2034
U-2659
11752129
May 27, 2042
Product
U-4266
11969409
May 27, 2042
Product
12427136
May 27, 2042
U-4291