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-seven 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
Summary for SPINRAZA
International Patents: | 597 |
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 |


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
Sponsor | Phase |
---|---|
Biogen | Phase 4 |
NYU Langone Health | Early Phase 1 |
Winthrop University Hospital | Early Phase 1 |
Pharmacology for SPINRAZA
Drug Class | Antisense Oligonucleotide Survival Motor Neuron-2-directed RNA Interaction |
Physiological Effect | Increased Protein Synthesis |
Anatomical Therapeutic Chemical (ATC) Classes for SPINRAZA
US Patents and Regulatory Information for SPINRAZA
SPINRAZA is protected by twenty-one US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SPINRAZA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Oligonucleotides containing 2'-O-modified purines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
FDA Regulatory Exclusivity protecting SPINRAZA
TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | See Plans and Pricing | See Plans and Pricing |
>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: See Plans and Pricing
Patent: 21134
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 10395
Estimated Expiration: See Plans and Pricing
Patent: 48560
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 10395
Estimated Expiration: See Plans and Pricing
Patent: 48560
Estimated Expiration: See Plans and Pricing
Patent: 44700
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
Patent: 70072
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 81307
Estimated Expiration: See Plans and Pricing
Patent: 47103
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 27486
Estimated Expiration: See Plans and Pricing
Patent: 700042
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 548560
Estimated Expiration: See Plans and Pricing
Patent: 2017037
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
Luxembourg
Patent: 0046
Estimated Expiration: See Plans and Pricing
Poland
Patent: 10395
Estimated Expiration: See Plans and Pricing
Patent: 48560
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 10395
Estimated Expiration: See Plans and Pricing
Patent: 48560
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 48560
Estimated Expiration: See Plans and Pricing
Patent: 08788
Estimated Expiration: See Plans and Pricing
Spain
Patent: 97113
Estimated Expiration: See Plans and Pricing
Patent: 45223
Estimated Expiration: See Plans and Pricing
Patent: 02531
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Israel | 105033 | See Plans and Pricing | |
Hong Kong | 1181307 | 用於調節 剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING SMN2) | See Plans and Pricing |
European Patent Office | 1004593 | See Plans and Pricing | |
Canada | 2073500 | COMPOSITIONS ET METHODES POUR DECELER ET MODULER L'ACTIVITE DE L'ARN ET L'EXPRESSION GENIQUE (COMPOSITIONS AND METHODS FOR DETECTING AND MODULATING RNA ACTIVITY AND GENE EXPRESSION) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPINRAZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2548560 | 17C1048 | France | See Plans and Pricing | PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
2548560 | CR 2017 00055 | Denmark | See Plans and Pricing | PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601 |
2548560 | C20170038 00228 | Estonia | See Plans and Pricing | PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017 |
1910395 | CA 2017 00054 | Denmark | See Plans and Pricing | 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 |