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. 12 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 Generics

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 Mankind Pharma Ltd and was approved on Feb 7, 2024.

Given below is the list of companies who have filed for Apremilast generic.


1. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Sep 21, 2021
30MG tablet Prescription ORAL AB Sep 21, 2021
10MG tablet Prescription ORAL AB Sep 21, 2021


2. AMNEAL

Amneal Eu Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Discontinued ORAL N/A Jun 30, 2021
10MG tablet Discontinued ORAL N/A Jun 30, 2021
20MG tablet Discontinued ORAL N/A Jun 30, 2021


3. ANNORA

Annora Pharma Private Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Annora.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jul 26, 2023
20MG tablet Prescription ORAL AB Jul 26, 2023
30MG tablet Prescription ORAL AB Jul 26, 2023


4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Jul 19, 2023
30MG tablet Discontinued ORAL N/A Jul 19, 2023
20MG tablet Discontinued ORAL N/A Jul 19, 2023


5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Discontinued ORAL N/A Jul 14, 2023
10MG tablet Discontinued ORAL N/A Jul 14, 2023
30MG tablet Discontinued ORAL N/A Jul 14, 2023


6. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Prescription ORAL AB Oct 16, 2023
10MG tablet Prescription ORAL AB Oct 16, 2023
20MG tablet Prescription ORAL AB Oct 16, 2023


7. MANKIND PHARMA

Mankind Pharma Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Feb 7, 2024
30MG tablet Prescription ORAL AB Feb 7, 2024
10MG tablet Prescription ORAL AB Feb 7, 2024


8. SHILPA

Shilpa Medicare Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Apr 7, 2023
10MG tablet Prescription ORAL AB Apr 7, 2023
30MG tablet Prescription ORAL AB Apr 7, 2023


9. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Discontinued ORAL N/A Aug 18, 2022
10MG tablet Discontinued ORAL N/A Aug 18, 2022
20MG tablet Discontinued ORAL N/A Aug 18, 2022


10. UNICHEM

Unichem Laboratories Ltd has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Discontinued ORAL N/A Feb 17, 2021
30MG tablet Discontinued ORAL N/A Feb 17, 2021
10MG tablet Discontinued ORAL N/A Feb 17, 2021


11. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Apremilast. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Prescription ORAL AB Sep 21, 2021
20MG tablet Prescription ORAL AB Sep 21, 2021
10MG tablet Prescription ORAL AB Sep 21, 2021