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Last Updated: May 20, 2022

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.

Drug patent expirations by year for TECFIDERA
Drug Prices for TECFIDERA

See drug prices for TECFIDERA

Recent Clinical Trials for TECFIDERA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2
Banner Life Sciences LLCPhase 1
Fondation Ophtalmologique Adolphe de RothschildPhase 4

See all TECFIDERA clinical trials

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
McKesson
AstraZeneca
Express Scripts
McKinsey

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