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Last Updated: June 1, 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-nine 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:579
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 Y Y   Start Trial
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes   Start Trial   Start Trial Y   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   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
1910395 122017000099 Germany   Start Trial PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530
2548560 300902 Netherlands   Start Trial PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560 17C1048 France   Start Trial PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601
1910395 CA 2017 00054 Denmark   Start Trial PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
1910395 1790053-1 Sweden   Start Trial PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REG. NO/DATE: EU/1/17/1188 20170601
2548560 LUC00046 Luxembourg   Start Trial PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560 2017C/048 Belgium   Start Trial PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Mallinckrodt
Harvard Business School
Merck
Colorcon

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.