SPINRAZA Drug Patent Profile

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 nine patents protecting this drug.

This drug has five hundred and ninety-seven patent family members in thirty-two 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.

DrugPatentWatch^® Generic Entry Outlook for Spinraza

Spinraza was eligible for patent challenges on December 23, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 27, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SPINRAZA

International Patents:	597
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	12
Drug Prices:	Drug price information for SPINRAZA
What excipients (inactive ingredients) are in SPINRAZA?	SPINRAZA excipients list
DailyMed Link:	SPINRAZA at DailyMed

See drug prices for SPINRAZA

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for SPINRAZA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	Phase 4
NYU Langone Health	Early Phase 1
Winthrop University Hospital	Early Phase 1

See all SPINRAZA clinical trials

Pharmacology for SPINRAZA

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

Anatomical Therapeutic Chemical (ATC) Classes for SPINRAZA

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 SPINRAZA

SPINRAZA is protected by twenty-one US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SPINRAZA

FDA Regulatory Exclusivity protecting 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				Y
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

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

International Patents for SPINRAZA

When does loss-of-exclusivity occur for SPINRAZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Lithuania

Luxembourg

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SPINRAZA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	105033
Hong Kong	1181307	用於調節 剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING SMN2)
European Patent Office	1004593
Canada	2073500	COMPOSITIONS ET METHODES POUR DECELER ET MODULER L'ACTIVITE DE L'ARN ET L'EXPRESSION GENIQUE (COMPOSITIONS AND METHODS FOR DETECTING AND MODULATING RNA ACTIVITY AND GENE EXPRESSION)

Supplementary Protection Certificates for SPINRAZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	17C1048	France		PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560	CR 2017 00055	Denmark		PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
2548560	C20170038 00228	Estonia		PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017
1910395	CA 2017 00054	Denmark		PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601