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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.

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

US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Drug Prices:	Drug price information for SPINRAZA
DailyMed Link:	SPINRAZA at DailyMed

Generic Entry Opportunity Date for SPINRAZA

NDA:

209531

Dosage:

SOLUTION;INTRATHECAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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

International Patents for SPINRAZA

Country	Document Number	Estimated Expiration
Hungary	9203452
Australia	777034
Australia	4894097
Germany	69333344

Supplementary Protection Certificates for SPINRAZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0170038 00228	Estonia		PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017
0905	Netherlands		PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2017037	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
0902	Netherlands		PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601