Nusinersen sodium - Generic Drug Details

What are the generic sources for nusinersen sodium and what is the scope of patent protection?

Nusinersen sodium is the generic ingredient in one branded drug marketed by Biogen Idec and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nusinersen sodium has one hundred and two patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for nusinersen sodium

International Patents:	102
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	nusinersen sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for nusinersen sodium

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 nusinersen sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for nusinersen sodium

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for nusinersen sodium

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				Y
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 nusinersen sodium

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

International Patents for nusinersen sodium

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2943225	COMPOSITIONS ET PROCÉDÉS POUR LA MODULATION DE L'ÉPISSAGE DE SMN2 CHEZ UN SUJET (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT)
Spain	2397113
European Patent Office	2644700	COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
South Korea	101965868
European Patent Office	1910395	Compositions et procédés de modulation de l épissage de SMN2 (Compositions and methods for modulation of SMN2 splicing)

Supplementary Protection Certificates for nusinersen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	358 21-2017	Slovakia		PRODUCT NAME: NUSINERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560	C02548560/01	Switzerland		PRODUCT NAME: NUSINERSEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66495 20.09.2017
2548560	2017C/048	Belgium		PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560	CA 2017 00055	Denmark		PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
2548560	PA2017037	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530