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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
Healthtrust
AstraZeneca
Argus Health
Deloitte
Citi
Queensland Health

Generated: April 26, 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-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: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:Apr 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 20, 2019Product 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 ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Cantor Fitzgerald
Mallinckrodt
Julphar
Fuji
US Department of Justice
Chinese Patent Office
Johnson and Johnson

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