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. Nineteen 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.
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Questions you can ask:
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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 |
![TECFIDERA drug patent expirations Drug patent expirations by year for TECFIDERA](/p/graph/s/t/TECFIDERA-patent-expirations.png)
![Drug Prices for TECFIDERA](/p/graph/drug-price/TECFIDERA.png)
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 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Treatment for multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>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 | |
Accord Healthcare S.L.U. | Dimethyl fumarate Accord | dimethyl fumarate | EMEA/H/C/005950 Dimethyl fumarate Accord 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 | 2023-02-15 | |
>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 |
---|---|---|---|
Austria | 242633 | ⤷ Sign Up | |
Finland | C20230002 | ⤷ Sign Up | |
Canada | 2942690 | FUMARATE DE DIMETHYLE ET REGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS) | ⤷ Sign Up |
Japan | 5828614 | ⤷ Sign Up | |
Slovakia | 285601 | ⤷ Sign Up | |
Hong Kong | 1139204 | COMPOSITIONS AND USES FOR TREATING MULTIPLE SCLEROSIS | ⤷ Sign Up |
Eurasian Patent Organization | 202191097 | СПОСОБЫ ЛЕЧЕНИЯ РАССЕЯННОГО СКЛЕРОЗА | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1131065 | PA2014023 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
2137537 | 310 5015-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: DIMETYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001 - EU/1/13/837/002 20140203 |
0605697 | SPC/GB01/008 | United Kingdom | ⤷ Sign Up | 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 |
2137537 | CA 2014 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
2137537 | 1490038-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203 |
2653873 | 301215 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837 20140203 |
2137537 | 122014000069 | Germany | ⤷ Sign Up | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |