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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 seven patents protecting this drug. Additional details are available on the TECFIDERA profile page.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-one 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 NDA: 204063

Tradename:
TECFIDERA
Applicant:
Biogen Idec Inc
Ingredient:
dimethyl fumarate
Patents:7
Formulation / Manufacturing:see details

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Mar 27, 2013TE:RLD:No
Patent:6,509,376Patent Expiration:Oct 29, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,759,393Patent Expiration:Oct 29, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,803,840Patent Expiration:Apr 1, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS


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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 verifification 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.

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