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Serving leading biopharmaceutical companies globally:

Fuji
Queensland Health
McKinsey
Argus Health
Express Scripts
Farmers Insurance
Julphar
Cerilliant
Healthtrust
Boehringer Ingelheim

Generated: February 21, 2018

DrugPatentWatch Database Preview

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 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-five 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:7
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 Biogen Inc. 64406-005 N 64406-005-01
TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063 NDA Biogen Inc. 64406-006 N 64406-006-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Mar 27, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 27, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Oct 29, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 18, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MULTIPLE SCLEROSIS

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Covington
Deloitte
Fish and Richardson
Mallinckrodt
Cipla
Dow
Healthtrust
Queensland Health
Chubb

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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