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SPINRAZA Drug Profile

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When do Spinraza patents expire, and when can generic versions of Spinraza launch?

Spinraza is a drug marketed by Biogen Idec and is included in one NDA. There are eight patents protecting this drug.

This drug has five hundred and forty-eight patent family members in twenty-five countries.

The generic ingredient in SPINRAZA is nusinersen sodium. One supplier is listed for this compound. Additional details are available on the nusinersen sodium profile page.

Summary for SPINRAZA

International Patents:	548
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
DailyMed Link:	SPINRAZA at DailyMed

Pharmacology for SPINRAZA

Ingredient-type	Oligonucleotides, Antisense
Drug Class	Survival Motor Neuron-2-directed RNA Interaction Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

US Patents and Regulatory Information for SPINRAZA

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
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes			Y	Y

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Expired US Patents for SPINRAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016

Non-Orange Book US Patents for SPINRAZA

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
9,476,042	Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
8,586,559	Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences

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International Patents for SPINRAZA

Country	Document Number	Estimated Expiration
Austria	219095
Canada	2223103
Japan	2732544
European Patent Office	1436307

Supplementary Protection Certificates for SPINRAZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0902	Netherlands		PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2017000099	Germany		PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530
0905	Netherlands		PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
0170038 00228	Estonia		PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017