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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.

There are five hundred and ninety-eight patent family members on BIOGEN IDEC drugs in thirty-eight countries and twenty-eight supplementary protection certificates in eleven countries.

Summary for Biogen Idec

International Patents:	598
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 Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013		RX	Yes	No
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013		RX	Yes	Yes	8,524,773
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013		RX	Yes	Yes	8,759,393		Y
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013		RX	Yes	No	7,619,001

Expired US Patents for Biogen Idec

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

Paragraph IV (Patent) Challenges for BIOGEN IDEC drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-releaseCapsules	120 mg and 240 mg		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
7,148,204	Antisense modulation of bcl-x expression
6,172,216	Antisense modulation of BCL-X expression
8,946,183	Compositions and methods for modulation of SMN2 splicing
7,915,310	Utilization of dialkylfumarates

International Patents for Biogen Idec Drugs

Country	Document Number	Estimated Expiration
China	1615839
Australia	9641201
Finland	944276
European Patent Office	2137537

Supplementary Protection Certificates for Biogen Idec Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017037	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2017 00055	Denmark		PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
2017 00054	Denmark		PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
487	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203

Similar Applicant Names

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

• Biogen Idec
• Biogen Idec Inc
• Bioglan