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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Healthtrust
Chubb
Cerilliant
Queensland Health
Merck
Boehringer Ingelheim
Cantor Fitzgerald
Teva

Generated: July 21, 2018

DrugPatentWatch Database Preview

Nusinersen sodium - Generic Drug Details

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What are the generic sources for nusinersen sodium and what is the scope of nusinersen sodium freedom to operate?

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 five hundred and forty-eight patent family members in twenty-five countries.

One supplier is listed for this compound.
Summary for nusinersen sodium
International Patents:548
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for nusinersen sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,107,933 Compositions and methods of targeting apolipoprotein B for the reduction of apolipoprotein C-III ➤ Sign Up
6,172,216 Antisense modulation of BCL-X expression ➤ Sign Up
6,214,986 Antisense modulation of bcl-x expression ➤ Sign Up
7,148,204 Antisense modulation of bcl-x expression ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for nusinersen sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0905 Netherlands ➤ Sign Up PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
0170038 00228 Estonia ➤ Sign Up PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017
2017000100 Germany ➤ Sign Up PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530
2017 00054 Denmark ➤ Sign Up PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Accenture
Argus Health
Boehringer Ingelheim
Daiichi Sankyo
Cerilliant
Medtronic
Harvard Business School

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 verifification 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.