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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
McKinsey
QuintilesIMS
Healthtrust
Covington
Harvard Business School
Mallinckrodt
AstraZeneca

Generated: September 21, 2018

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Biogen Idec Company Profile

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What is the competitive landscape for BIOGEN IDEC, and what generic alternatives to BIOGEN IDEC drugs are available?

BIOGEN IDEC has two approved drugs.

There are fifteen US patents protecting BIOGEN IDEC drugs.

Summary for Biogen Idec
US Patents:15
Tradenames:2
Ingredients:2
NDAs:2
Patent Litigation for Biogen Idec: See patent lawsuits for Biogen Idec

Drugs and US Patents for Biogen Idec

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes 8,110,560 ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes 8,524,773 ➤ Sign Up ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes 7,838,657 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Biogen Idec

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,759,393 ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 6,166,197 ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 8,524,773 ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,524,773 ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 8,759,393 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BIOGEN IDEC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-releaseCapsules 120 mg and 240 mg ➤ Subscribe 2017-03-27

Non-Orange Book US Patents for Biogen Idec

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,586,559 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences ➤ Sign Up
8,946,183 Compositions and methods for modulation of SMN2 splicing ➤ Sign Up
6,172,216 Antisense modulation of BCL-X expression ➤ Sign Up
7,915,310 Utilization of dialkylfumarates ➤ Sign Up
9,107,933 Compositions and methods of targeting apolipoprotein B for the reduction of apolipoprotein C-III ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Biogen Idec Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
487 Luxembourg ➤ Sign Up PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
2014 00036 Denmark ➤ Sign Up PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
8 Finland ➤ Sign Up
C/GB02/030 United Kingdom ➤ Sign Up PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
C/GB01/008 United Kingdom ➤ Sign Up PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
McKinsey
Federal Trade Commission
Deloitte
Farmers Insurance
UBS
AstraZeneca
Accenture

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