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Last Updated: January 27, 2022

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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 nine patents protecting this drug.

This drug has five hundred and ninety-two patent family members in thirty-two 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:592
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 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 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
BiogenPhase 4
Winthrop University HospitalEarly Phase 1
NYU Langone HealthEarly Phase 1

See all SPINRAZA clinical trials

US Patents and Regulatory Information for SPINRAZA

SPINRAZA is protected by twenty-one US patents and three FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Try it Free.

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 it Free
Patent Expiration: ⤷  Try it Free
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 it Free
Patent Expiration: ⤷  Try it Free
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 it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

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

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

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

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

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

Oligonucleotides containing 2'-O-modified purines
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

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

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

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

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

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

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

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

FDA Regulatory Exclusivity protecting SPINRAZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try it Free

TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
Exclusivity Expiration: ⤷  Try it Free

CHANGES TO THE LABELING BASED ON RESULTS FROM A CONTROLLED CLINICAL TRIAL IN PATIENTS WITH LATER-ONSET SPINAL MUSCULAR ATROPHY
Exclusivity Expiration: ⤷  Try it Free

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 it Free ⤷  Try it Free ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SPINRAZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2548560 LUC00046 Luxembourg ⤷  Try it Free PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560 122017000100 Germany ⤷  Try it Free PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530
1910395 300905 Netherlands ⤷  Try it Free PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560 57/2017 Austria ⤷  Try it Free PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601
2548560 PA2017037 Lithuania ⤷  Try it Free PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560 358 21-2017 Slovakia ⤷  Try it Free PRODUCT NAME: NUSINERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1188 20170601
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Mallinckrodt
Harvard Business School
Merck
Colorcon

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