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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 204063


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NDA 204063 describes TECFIDERA, which is a drug marketed by Biogen Inc and is included in one NDA. It is available from two suppliers. There are nine 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. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 204063
Tradename:TECFIDERA
Applicant:Biogen Inc
Ingredient:dimethyl fumarate
Patents:9
Formulation / Manufacturing:see details
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 AUTHORIZED GENERIC TEVA PHARMACEUTICALS USA, INC. 0093-9219 0093-9219-06 1 BOTTLE, PLASTIC in 1 CARTON (0093-9219-06) / 60 CAPSULE in 1 BOTTLE, PLASTIC
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Mar 27, 2013TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Patent:⤷  Try a TrialPatent Expiration:Nov 16, 2035Product 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 Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.