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Last Updated: February 16, 2020

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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 nine patents protecting this drug.

This drug has five hundred and seventy-five patent family members in thirty 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.

US ANDA Litigation and Generic Entry Outlook for Spinraza

Spinraza will be eligible for patent challenges on December 23, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 27, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SPINRAZA
International Patents:575
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for SPINRAZA
DailyMed Link:SPINRAZA at DailyMed
Drug patent expirations by year for SPINRAZA
Drug Prices for SPINRAZA

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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.

Recent Clinical Trials for SPINRAZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU Langone HealthEarly Phase 1
Winthrop University HospitalEarly Phase 1

See all SPINRAZA clinical trials

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

Supplementary Protection Certificates for SPINRAZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2548560 57/2017 Austria   Start Trial PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601
2548560 122017000100 Germany   Start Trial PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530
1910395 300905 Netherlands   Start Trial PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
1910395 2017/051 Ireland   Start Trial PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTRATION NO/DATE: EU/1/17/1188 20170530
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Express Scripts
Dow
Mallinckrodt
Harvard Business School

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