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Last Updated: April 14, 2021

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TECFIDERA Drug Profile

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When do Tecfidera patents expire, and what generic alternatives are available?

Tecfidera is a drug marketed by Biogen Idec Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in thirty-two 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.

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Drug patent expirations by year for TECFIDERA
Drug Prices for TECFIDERA

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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
Universita degli Studi di GenovaPhase 4

See all TECFIDERA clinical trials

Paragraph IV (Patent) Challenges for TECFIDERA
Tradename Dosage Ingredient NDA Submissiondate
TECFIDERA CAPSULE, DELAYED RELEASE;ORAL dimethyl fumarate 204063 2017-03-27

US Patents and Regulatory Information for TECFIDERA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No   Start Trial   Start Trial   Start 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 Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TECFIDERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137537 SPC/GB14/046 United Kingdom   Start Trial PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203
2137537 92487 Luxembourg   Start Trial PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
1131065 92488 Luxembourg   Start Trial PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
McKesson
AstraZeneca
Express Scripts
McKinsey

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