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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 204063


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NDA 204063 describes TECFIDERA, which is a drug marketed by Biogen Idec Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TECFIDERA profile page.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 204063
Tradename:TECFIDERA
Applicant:Biogen Idec Inc
Ingredient:dimethyl fumarate
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204063
Generic Entry Date for 204063*:
Constraining patent/regulatory exclusivity:
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
Dosage:
CAPSULE, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 204063
Suppliers and Packaging for NDA: 204063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063 NDA Biogen Inc. 64406-005 64406-005-01 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) > 14 CAPSULE in 1 BOTTLE, PLASTIC
TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063 NDA Biogen Inc. 64406-006 64406-006-02 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) > 60 CAPSULE in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 204063
Tradename Dosage Ingredient NDA Submissiondate
TECFIDERA CAPSULE, DELAYED RELEASE;ORAL dimethyl fumarate 204063 2017-03-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Mar 27, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 5, 2023
Regulatory Exclusivity Use: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
Patent:  Start TrialPatent Expiration:Jun 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MULTIPLE SCLEROSIS
Patent:  Start TrialPatent Expiration:Feb 7, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MULTIPLE SCLEROSIS

Expired US Patents for NDA 204063

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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