Dimethyl Fumarate Patent Expiration
Dimethyl Fumarate is Used for treating autoimmune diseases such as multiple sclerosis and relapsing forms before and after administering an inactive vaccine. It was first introduced by Biogen Inc
Dimethyl Fumarate Patents
Given below is the list of patents protecting Dimethyl Fumarate, 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 |
|---|---|---|---|---|
| Tecfidera | US10391160 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US10555993 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US10959972 | Methods of treating multiple sclerosis | Nov 16, 2035 | Biogen Inc |
| Tecfidera | US10994003 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US11007166 | Methods of treating multiple sclerosis | Nov 16, 2035 | Biogen Inc |
| Tecfidera | US11007167 | Methods of treating multiple sclerosis | Nov 16, 2035 | Biogen Inc |
| Tecfidera | US11129806 | Methods of treating multiple sclerosis | Nov 16, 2035 | Biogen Inc |
| Tecfidera | US11246850 | Methods of treating multiple sclerosis | Nov 16, 2035 | Biogen Inc |
| Tecfidera | US6509376 | Utilization of dialkyfumarates |
Oct 29, 2019
(Expired) | Biogen Inc |
| Tecfidera | US7320999 | Dimethyl fumarate for the treatment of multiple sclerosis |
May 18, 2020
(Expired) | Biogen Inc |
| Tecfidera | US7619001 | Utilization of dialkylfumarates |
Apr 01, 2018
(Expired) | Biogen Inc |
| Tecfidera | US7803840 | Utilization of dialkylfumarates |
Apr 01, 2018
(Expired) | Biogen Inc |
| Tecfidera | US8399514 | Treatment for multiple sclerosis | Feb 07, 2028 | Biogen Inc |
| Tecfidera | US8524773 | Utilization of dialkylfumarates |
Apr 01, 2018
(Expired) | Biogen Inc |
| Tecfidera | US8759393 | Utilization of dialkylfumarates |
Jul 04, 2018
(Expired) | Biogen Inc |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dimethyl Fumarate's patents.
Latest Legal Activities on Dimethyl Fumarate's Patents
Given below is the list recent legal activities going on the following patents of Dimethyl Fumarate.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 18 Mar, 2024 | US10555993 |
| Maintenance Fee Reminder Mailed | 02 Oct, 2023 | US10555993 |
| Termination or Final Written Decision | 03 Feb, 2023 | US8399514 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10391160 |
| Expire Patent | 31 Oct, 2022 | US7803840 |
| Expire Patent | 01 Aug, 2022 | US8759393 |
| Maintenance Fee Reminder Mailed | 16 May, 2022 | US7803840 |
| Patent Issue Date Used in PTA Calculation | 15 Feb, 2022 | US11246850 |
| Recordation of Patent Grant Mailed | 15 Feb, 2022 | US11246850 |
| Maintenance Fee Reminder Mailed | 14 Feb, 2022 | US8759393 |
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Dimethyl Fumarate Generics
Several generic applications have been filed for Dimethyl Fumarate. The first generic version for Dimethyl Fumarate was by Mylan Pharmaceuticals Inc and was approved on Aug 17, 2020. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on Jun 26, 2024.
Given below is the list of companies who have filed for Dimethyl Fumarate generic.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
2. MYLAN
Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Aug 17, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Aug 17, 2020 |
3. CIPLA
Cipla Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
4. AMNEAL
Amneal Eu Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
5. LUPIN
Lupin Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Lupin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Oct 5, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Oct 5, 2020 |
6. TWI PHARMS
Twi Pharmaceuticals Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Twi Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Oct 14, 2020 |
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Oct 14, 2020 |
7. SAWAI USA
Sawai Usa Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Sawai Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 240MG | capsule, delayed release | Discontinued | ORAL | N/A | Dec 21, 2021 |
| 120MG | capsule, delayed release | Discontinued | ORAL | N/A | Dec 21, 2021 |
8. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
9. PRINSTON INC
Prinston Pharmaceutical Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Prinston Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Oct 18, 2022 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Oct 18, 2022 |
10. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Dec 22, 2022 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Dec 22, 2022 |
11. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
12. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. 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 |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Sep 24, 2020 |
13. SOLA PHARMS
Sola Pharmaceuticals has filed for 2 different strengths of generic version for Dimethyl Fumarate. Given below are the details of the strengths of this generic introduced by Sola Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Mar 26, 2021 |
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Mar 26, 2021 |
14. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Dimethyl Fumarate. 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 |
|---|---|---|---|---|---|
| 240MG | capsule, delayed release | Discontinued | ORAL | N/A | Sep 24, 2020 |
| 120MG | capsule, delayed release | Discontinued | ORAL | N/A | Sep 24, 2020 |
15. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. 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 |
|---|---|---|---|---|---|
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Jun 26, 2024 |
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Jun 26, 2024 |
16. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Dimethyl Fumarate. 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 |
|---|---|---|---|---|---|
| 120MG | capsule, delayed release | Prescription | ORAL | AB | Oct 6, 2020 |
| 240MG | capsule, delayed release | Prescription | ORAL | AB | Oct 6, 2020 |