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 | US10959972 | Methods of treating multiple sclerosis | Nov 16, 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 | US10391160 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US10555993 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US10994003 | Dimethyl fumarate and vaccination regimens | Mar 13, 2035 | Biogen Inc |
| Tecfidera | US8399514 | Treatment for multiple sclerosis | Feb 07, 2028 | Biogen Inc |
| Tecfidera | US7320999 | Dimethyl fumarate for the treatment of multiple sclerosis |
May 18, 2020
(Expired) | Biogen Inc |
| Tecfidera | US6509376 | Utilization of dialkyfumarates |
Oct 29, 2019
(Expired) | Biogen Inc |
| Tecfidera | US8759393 | Utilization of dialkylfumarates |
Jul 04, 2018
(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 | US8524773 | Utilization of dialkylfumarates |
Apr 01, 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 18 Mar, 2024 | US10555993 |
| Maintenance Fee Reminder Mailed Critical | 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 Critical | 31 Oct, 2022 | US7803840 |
| Expire Patent Critical | 01 Aug, 2022 | US8759393 |
| Maintenance Fee Reminder Mailed Critical | 16 May, 2022 | US7803840 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Feb, 2022 | US11246850 |
| Recordation of Patent Grant Mailed Critical | 15 Feb, 2022 | US11246850 |
| Maintenance Fee Reminder Mailed Critical | 14 Feb, 2022 | US8759393 |
Dimethyl Fumarate's Family Patents
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Dimethyl Fumarate Generic API Manufacturers
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, along with the locations of their manufacturing plants worldwide.
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. 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 |
3. 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 |
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.
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| United States |
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| India |
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4. 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 |
Manufacturing Plant Locations New
Aurobindo Pharma'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 Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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5. 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 |
Manufacturing Plant Locations New
Cipla'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 Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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6. 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 |
7. 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 |
8. 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 |
Manufacturing Plant Locations New
Lupin'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 Lupin as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
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| India |
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| United States |
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9. 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 |
10. 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 |
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 |
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| United States |
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11. 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 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |