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. 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
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 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 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 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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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.


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