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
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 | Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast | May 29, 2034 | 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 | US6020358 | Substituted phenethylsulfones and method of reducing TNFα levels |
Oct 30, 2018
(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 | 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 |
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 | US7659302 | Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione |
Mar 19, 2023
(Expired) | 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 | 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 | US9872854 | Methods for the treatment of psoriatic arthritis using apremilast | May 29, 2034 | Amgen Inc |
| Otezla |
US9872854 (Pediatric) | Methods for the treatment of psoriatic arthritis using apremilast | Nov 29, 2034 | Amgen Inc |
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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. 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 |
2. 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 |
3. 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 |
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. 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 |
6. 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 |
7. 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 |
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 |
| 30MG | tablet | Prescription | ORAL | AB | Feb 7, 2024 |
| 10MG | tablet | Prescription | ORAL | AB | Feb 7, 2024 |
9. 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 |
10. 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 |
11. 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 |