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 fifty-seven patent family members in twenty-three countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Seventeen 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: | 57 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 56 |
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 and one FDA Regulatory Exclusivity.
Patents protecting TECFIDERA
Dimethyl fumarate and vaccination regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Dimethyl fumarate and vaccination regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Dimethyl fumarate and vaccination regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Treatment for multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
FDA Regulatory Exclusivity protecting TECFIDERA
INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TECFIDERA
See the table below for patents covering TECFIDERA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Morocco | 39743 | FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS) | See Plans and Pricing |
European Patent Office | 3804711 | MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (METHODS OF TREATING MULTIPLE SCLEROSIS) | See Plans and Pricing |
Norway | 20121479 | See Plans and Pricing | |
Mexico | 2017006473 | METODOS PARA TRATAR LA ESCLEROSIS MULTIPLE. (METHODS OF TREATING MULTIPLE SCLEROSIS.) | See Plans and Pricing |
Japan | 2017537089 | 多発性硬化症の治療方法 | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2137537 | C300674 | Netherlands | See Plans and Pricing | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
0526708 | SPC/GB02/030 | United Kingdom | See Plans and Pricing | PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS |
1761528 | CR 2014 00055 | Denmark | See Plans and Pricing | PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702 |
1131065 | 92488 | Luxembourg | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130 |
2137537 | 1490038-5 | Sweden | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |