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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.


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


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
East Hanover Amneal Pharmaceuticals LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Piscataway Amneal Pharmaceuticals, LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
India
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





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


Manufacturing Plant Locations
New

Annora's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





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


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





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
10MG

tablet Discontinued ORAL N/A Oct 16, 2023
20MG

tablet Discontinued ORAL N/A Oct 16, 2023
30MG

tablet Discontinued ORAL N/A Oct 16, 2023





7. MACLEODS PHARMS LTD

Macleods 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 Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Nov 25, 2024
10MG

tablet Discontinued ORAL N/A Nov 25, 2024
30MG

tablet Discontinued ORAL N/A Nov 25, 2024





8. 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
10MG

tablet Prescription ORAL AB Feb 7, 2024
30MG

tablet Prescription ORAL AB Feb 7, 2024


Manufacturing Plant Locations
New

Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.

Country City Firm Name
India
Imt Manesar Mankind Pharma Limited
Paonta Sahib Mankind Pharma Limited





9. MSN

Msn Laboratories 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 Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Dec 16, 2024
20MG

tablet Prescription ORAL AB Dec 16, 2024
30MG

tablet Prescription ORAL AB Dec 16, 2024


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Laboratories Private Ltd.
Yadadri Bhuvanagiri District MSN Organics Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Kamareddy MSN Life Sciences Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Rangareddy District MSN Laboratories Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





10. 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


Manufacturing Plant Locations
New

Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Bengaluru Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited





11. 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





12. TORRENT

Torrent 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 Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

tablet Prescription ORAL AB Jun 20, 2025
10MG

tablet Prescription ORAL AB Jun 20, 2025
20MG

tablet Prescription ORAL AB Jun 20, 2025


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Pithampur Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





13. 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


Manufacturing Plant Locations
New

Unichem's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Unichem as present at those locations.

Country City Firm Name
India
Pithampur Unichem Laboratories Limited
Pilerne Bardez Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
Kolhapur Unichem Laboratories Limited
Ghaziabad Unichem Laboratories Ltd.
District Raigad Unichem Laboratories Ltd
United States
East Brunswick Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc





14. 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