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Last Updated: November 29, 2022

Nusinersen sodium - Generic Drug Details


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What are the generic drug 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nusinersen sodium has five hundred and ninety-five patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for nusinersen sodium
International Patents:595
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:nusinersen sodium at DailyMed

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

International Patents for nusinersen sodium

Country Patent Number Title Estimated Expiration
Germany 69433036 See Plans and Pricing
European Patent Office 0529008 PROCEDES DE MODULATION DE L'EXPRESSION DES GENES PAR L'INTERFERENCE DANS LA STRUCTURE SECONDAIRE DE L'ARN (MODULATION OF GENE EXPRESSION THROUGH INTERFERENCE WITH RNA SECONDARY STRUCTURE) See Plans and Pricing
Canada 2353108 See Plans and Pricing
Hong Kong 1246648 用於在受試者中調節SMN2剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT) See Plans and Pricing
Australia 9492601 See Plans and Pricing
Germany 69131848 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nusinersen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2548560 C201730053 Spain See Plans and Pricing PRODUCT NAME: NUSINERSEN O SUS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/17/1188; DATE OF AUTHORISATION: 20170530; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1188; DATE OF FIRST AUTHORISATION IN EEA: 20170530
1910395 132017000128668 Italy See Plans and Pricing PRODUCT NAME: NUSINERSEN O SUOI SALI(SPINRAZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1188, 20170601
1910395 CA 2017 00054 Denmark See Plans and Pricing PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
2548560 17C1048 France See Plans and Pricing PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560 LUC00046 Luxembourg See Plans and Pricing PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
1910395 2017C/047 Belgium See Plans and Pricing 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. 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.