Last Updated: June 13, 2026

NUSINERSEN SODIUM - Generic Drug Details

Name: NUSINERSEN SODIUM Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nusinersen sodium has one hundred and six patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for NUSINERSEN SODIUM

International Patents:	106
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUSINERSEN SODIUM
DailyMed Link:	NUSINERSEN SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NUSINERSEN SODIUM

Generic Entry Date for NUSINERSEN SODIUM^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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

Paragraph IV (Patent) Challenges for NUSINERSEN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPINRAZA	Intrathecal Solution	nusinersen sodium	12 mg/5 mL	209531	1	2026-03-10

US Patents and Regulatory Information for NUSINERSEN SODIUM

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Glossary

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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	209531-003	Mar 27, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-003	Mar 27, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NUSINERSEN SODIUM

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

International Patents for NUSINERSEN SODIUM

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Country	Patent Number	Title	Estimated Expiration
Poland	2548560		⤷ Start Trial
San Marino	T201800587		⤷ Start Trial
Hungary	E046966		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NUSINERSEN SODIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	122017000100	Germany	⤷ Start Trial	PRODUCT NAME: NUSINERSEN ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/17/1188 20170530
2548560	CR 2017 00055	Denmark	⤷ Start Trial	PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
2548560	2017C/048	Belgium	⤷ Start Trial	PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.