Apremilast Patent Expiration

Apremilast is used for treating psoriatic arthritis and plaque psoriasis with dosage titration and inhibiting PDE4. It was first introduced by Amgen Inc in its drug Otezla on Mar 21, 2014. Another drug containing Apremilast is Otezla Xr. 15 different companies have introduced drugs containing Apremilast.


Apremilast Patents

Given below is the list of patents protecting Apremilast, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Otezla Xr US11752129 Formulations Of Apremilast May 27, 2042 Amgen Inc
Otezla Xr US11969409 Formulations Of Apremilast May 27, 2042 Amgen Inc
Otezla Xr US12427136 Formulations Of Apremilast May 27, 2042 Amgen Inc
Otezla US10092541

(Pediatric)

Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast Nov 29, 2034 Amgen Inc
Otezla US9872854

(Pediatric)

Methods for the treatment of psoriatic arthritis using apremilast Nov 29, 2034 Amgen Inc
Otezla US12576034

(Pediatric)

Formulations Of (+)-2-[1-(3-Ethoxy-4-Methoxy-Phenyl)-2-Methanesulfonyl-Ethyl]-4-Acetylaminoisoindoline-1,3-Dione May 30, 2034 Amgen Inc
Otezla US10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast May 29, 2034 Amgen Inc
Otezla US9872854 Methods for the treatment of psoriatic arthritis using apremilast May 29, 2034 Amgen Inc
Otezla Xr US10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast May 29, 2034 Amgen Inc
Otezla US12576034 Formulations Of (+)-2-[1-(3-Ethoxy-4-Methoxy-Phenyl)-2-Methanesulfonyl-Ethyl]-4-Acetylaminoisoindoline-1,3-Dione Nov 30, 2033 Amgen Inc
Otezla US7427638

(Pediatric)

(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof Aug 16, 2028 Amgen Inc
Otezla US7427638 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof Feb 16, 2028 Amgen Inc
Otezla Xr US7427638 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof Feb 16, 2028 Amgen Inc
Otezla US7893101 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof Dec 09, 2023

(Expired)

Amgen Inc
Otezla US6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof Mar 19, 2023

(Expired)

Amgen Inc
Otezla US7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione Mar 19, 2023

(Expired)

Amgen Inc
Otezla US7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione Mar 19, 2023

(Expired)

Amgen Inc
Otezla US8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione Mar 19, 2023

(Expired)

Amgen Inc
Otezla US8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione Mar 19, 2023

(Expired)

Amgen Inc
Otezla US9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof Mar 19, 2023

(Expired)

Amgen Inc
Otezla US9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione Mar 19, 2023

(Expired)

Amgen Inc
Otezla US6020358 Substituted phenethylsulfones and method of reducing TNFα levels Oct 30, 2018

(Expired)

Amgen Inc



Apremilast's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Apremilast:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis Amgen NA RECRUITING
(Sep 1, 2026)
PHASE3
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET National Institute of Mental Health (NIMH) NA RECRUITING
(Aug 13, 2026)
PHASE1
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis Amgen NA COMPLETED
(Aug 1, 2026)
PHASE3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease Amgen NA RECRUITING
(Jul 1, 2026)
PHASE3
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis Amgen NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
HPP737 in Adult Patients With Plaque Psoriasis Newsoara Biopharma Co., Ltd. NA COMPLETED
(Jul 1, 2026)
PHASE3
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder Yale University NA RECRUITING
(Jun 1, 2026)
PHASE2
Apremilast for Erythema Multiforme Robert Micheletti NA COMPLETED
(May 1, 2026)
PHASE2
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis Alumis Inc NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 Alumis Inc NA COMPLETED
(Apr 1, 2026)
PHASE3
Human Laboratory Study of Apremilast for Alcohol Use Disorder National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Apr 1, 2026)
PHASE2
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. Eman Raafat Said NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO Centre Hospitalier Universitaire de Nice NA COMPLETED
(Mar 1, 2026)
PHASE2
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients QuantumLeap Healthcare Collaborative NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2


Apremilast Generic API Manufacturers

Several generic applications have been filed for Apremilast. The first generic version for Apremilast was by Unichem Laboratories Ltd and was approved on Feb 17, 2021. And the latest generic version is by Torrent Pharmaceuticals Ltd and was approved on Jun 20, 2025.

Given below is the list of companies who have filed for Apremilast generic, along with the locations of their manufacturing plants worldwide.


Apremilast News

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