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Last Updated: April 22, 2024

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SPINRAZA Drug Patent 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 one hundred and two patent family members in twenty-seven 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.

DrugPatentWatch® Generic Entry Outlook for Spinraza

Spinraza was eligible for patent challenges on December 23, 2020.

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:102
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 12
Drug Prices: Drug price information for SPINRAZA
What excipients (inactive ingredients) are in SPINRAZA?SPINRAZA excipients list
DailyMed Link:SPINRAZA at DailyMed
Drug patent expirations by year for SPINRAZA
Drug Prices for SPINRAZA

See drug prices for SPINRAZA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
BiogenPhase 4
NYU Langone HealthEarly Phase 1
Winthrop University HospitalEarly Phase 1

See all SPINRAZA clinical trials

US Patents and Regulatory Information for SPINRAZA

SPINRAZA is protected by twenty US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SPINRAZA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SPINRAZA

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE

Methods for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE

Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA

Compositions and methods for modulation of SMN2 splicing
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

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 Y ⤷  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 Y ⤷  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
>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 SPINRAZA

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 SPINRAZA

When does loss-of-exclusivity occur for SPINRAZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Patent: 16663
Estimated Expiration: ⤷  Try a Trial

Patent: 21134
Estimated Expiration: ⤷  Try a Trial

Patent: 17040
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 10395
Estimated Expiration: ⤷  Try a Trial

Patent: 48560
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 10395
Estimated Expiration: ⤷  Try a Trial

Patent: 48560
Estimated Expiration: ⤷  Try a Trial

Patent: 44700
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

Patent: 70072
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 81307
Estimated Expiration: ⤷  Try a Trial

Patent: 47103
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27486
Estimated Expiration: ⤷  Try a Trial

Patent: 700042
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 548560
Estimated Expiration: ⤷  Try a Trial

Patent: 2017037
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0046
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 10395
Estimated Expiration: ⤷  Try a Trial

Patent: 48560
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 10395
Estimated Expiration: ⤷  Try a Trial

Patent: 48560
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 48560
Estimated Expiration: ⤷  Try a Trial

Patent: 08788
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 97113
Estimated Expiration: ⤷  Try a Trial

Patent: 45223
Estimated Expiration: ⤷  Try a Trial

Patent: 02531
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SPINRAZA around the world.

Country Patent Number Title Estimated Expiration
Canada 2082044 MODULATION DE L'EXPRESSION GENETIQUE PAR INTERFERENCE AVEC LA STRUCTURE SECONDAIRE DE L'ARN (MODULATION OF GENE EXPRESSION THROUGH INTERFERENCE WITH RNA SECONDARY STRUCTURE) ⤷  Try a Trial
Canada 2089563 MODULATION DE L'ADHERENCE CELLULAIRE GRACE A DES OLIGONUCLEOTIDES (OLIGONUCLEOTIDE MODULATION OF CELL ADHESION) ⤷  Try a Trial
Japan 3131222 ⤷  Try a Trial
Canada 2353108 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SPINRAZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1910395 2017C/047 Belgium ⤷  Try a Trial PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560 PA2017037,C2548560 Lithuania ⤷  Try a Trial PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560 SPC/GB17/069 United Kingdom ⤷  Try a Trial PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTERED: UK EU/1/17/1188 20170601
1910395 CA 2017 00054 Denmark ⤷  Try a Trial PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601
>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.