tecfidera Drug Patent Profile
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When do Tecfidera patents expire, and what generic alternatives are available?
Tecfidera is a drug marketed by Biogen Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-seven patent family members in twenty-nine countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tecfidera
A generic version of tecfidera was approved as dimethyl fumarate by MYLAN on August 17th, 2020.
Summary for tecfidera
| International Patents: | 87 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 57 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for tecfidera |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tecfidera |
| What excipients (inactive ingredients) are in tecfidera? | tecfidera excipients list |
| DailyMed Link: | tecfidera at DailyMed |
Recent Clinical Trials for tecfidera
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 2 |
| Banner Life Sciences LLC | Phase 1 |
| Fondation Ophtalmologique Adolphe de Rothschild | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for tecfidera
Paragraph IV (Patent) Challenges for TECFIDERA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TECFIDERA | Delayed-release Capsules | dimethyl fumarate | 120 mg and 240 mg | 204063 | 29 | 2017-03-27 |
US Patents and Regulatory Information for tecfidera
tecfidera is protected by nine US patents.
Patents protecting tecfidera
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Treatment for multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for tecfidera
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for tecfidera
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Almirall S.A | Skilarence | dimethyl fumarate | EMEA/H/C/002157 Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. |
Authorised | no | no | no | 2017-06-23 | |
| Biogen Netherlands B.V. | Tecfidera | dimethyl fumarate | EMEA/H/C/002601 Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). |
Authorised | no | no | no | 2014-01-30 | |
| Mylan Ireland Limited | Dimethyl fumarate Mylan | dimethyl fumarate | EMEA/H/C/005956 Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. | Dimethyl fumarate Polpharma | dimethyl fumarate | EMEA/H/C/005955 Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Laboratorios Lesvi S.L. | Dimethyl fumarate Neuraxpharm | dimethyl fumarate | EMEA/H/C/006039 Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Teva GmbH | Dimethyl fumarate Teva | dimethyl fumarate | EMEA/H/C/005963 Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). |
Authorised | yes | no | no | 2022-12-12 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for tecfidera
See the table below for patents covering tecfidera around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 299409 | Použití jednoho nebo více dialkylfumarátu k výrobe farmaceutického prípravku a farmaceutický prípravek (Use of one or more dialkyl fumarates for preparing a pharmaceutical composition and the pharmaceutical composition per se) | ⤷ Try a Trial |
| Australia | 2021269298 | Method of treating multiple sclerosis | ⤷ Try a Trial |
| Japan | 2017226681 | ジアルキルフマレート含有薬剤調合物 (PHARMACEUTICAL PREPARATIONS COMPRISING DIALKYL FUMARATES) | ⤷ Try a Trial |
| Austria | 242633 | ⤷ Try a Trial | |
| China | 113368091 | 治疗多发性硬化的方法 (Methods of treating multiple sclerosis) | ⤷ Try a Trial |
| Norway | 333257 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tecfidera
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137537 | 300674 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2653873 | PA2023503 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DIMETILFUMARATAS; REGISTRATION NO/DATE: EU/1/13/837 20140130 |
| 0605697 | SPC/GB01/008 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026 |
| 2441753 | SPC/GB17/036 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALECTINIB (9-ETHYL-6,6-DIMETHYL-8-(4-MORPHOLIN-4-YL-PIPERIDIN-1-YL)-11-OXO-6,11-DIHYDRO-5H-BENZO(B)CARBAZOLE-3-CARBONITRILE) OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/16/1169 (NI) 20170220; UK PLGB 00031/0843 20170220 |
| 2137537 | SPC/GB14/046 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203 |
| 2137537 | 122014000069 | Germany | ⤷ Try a Trial | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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