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Last Updated: February 25, 2024

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-nine patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for nusinersen sodium
International Patents:599
US Patents:9
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
Generic Entry Date for nusinersen sodium*:
Constraining patent/regulatory exclusivity:
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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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

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

International Patents for nusinersen sodium

Country Patent Number Title Estimated Expiration
Finland 951467 ⤷  Try a Trial
Australia 654816 ⤷  Try a Trial
Australia 2002360336 ⤷  Try a Trial
China 115227709 用于在对象中调节SMN2剪接的组合物和方法 (Compositions and methods for modulating SMN2 splicing in subject) ⤷  Try a Trial
Cyprus 1122687 ⤷  Try a Trial
Australia 661662 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nusinersen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1910395 2017/051 Ireland ⤷  Try a Trial PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTRATION NO/DATE: EU/1/17/1188 20170530
2548560 C20170038 00228 Estonia ⤷  Try a Trial PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017
2548560 C 2017 045 Romania ⤷  Try a Trial PRODUCT NAME: NUSINERSEN SAU SARURI ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1188; DATE OF NATIONAL AUTHORISATION: 20170530; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1188; DATE OF FIRST AUTHORISATION IN EEA: 20170530
2548560 C02548560/01 Switzerland ⤷  Try a Trial PRODUCT NAME: NUSINERSEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66495 20.09.2017
2548560 SPC/GB17/069 United Kingdom ⤷  Try a Trial PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTERED: UK EU/1/17/1188 20170601
2548560 C201730053 Spain ⤷  Try a Trial 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
>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.