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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chubb
Baxter
Cipla
Harvard Business School
Farmers Insurance
Federal Trade Commission
Express Scripts
Fish and Richardson

Generated: July 19, 2018

DrugPatentWatch Database Preview

SPINRAZA Drug Profile

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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 eight patents protecting this drug.

This drug has five hundred and forty-eight patent family members in twenty-five 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.
Summary for SPINRAZA
International Patents:548
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:SPINRAZA at DailyMed
Drug patent expirations by year for SPINRAZA
Generic Entry Opportunity Date for SPINRAZA
Generic Entry Date for SPINRAZA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for 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 ➤ 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 ➤ Sign Up
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
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 SPINRAZA

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
9,476,042 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences ➤ Sign Up
6,172,216 Antisense modulation of BCL-X expression ➤ Sign Up
7,148,204 Antisense modulation of bcl-x expression ➤ Sign Up
8,586,559 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SPINRAZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017037 Lithuania ➤ Sign Up PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
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
0902 Netherlands ➤ Sign Up PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION 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:

Cantor Fitzgerald
Fuji
QuintilesIMS
Boehringer Ingelheim
Queensland Health
Dow
Federal Trade Commission
US Department of Justice
UBS

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.