SPINRAZA Drug Patent Profile
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Which patents cover Spinraza, and what generic alternatives are available?
Spinraza is a drug marketed by Biogen Idec and is included in one NDA. There are nine 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 December 23, 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: | 9 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SPINRAZA
*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 |
US Patents and Regulatory Information for SPINRAZA
SPINRAZA is protected by twenty-six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SPINRAZA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Patent: 21134
Estimated Expiration: ⤷ Sign Up
Patent: 17040
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 10395
Estimated Expiration: ⤷ Sign Up
Patent: 48560
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10395
Patent: Compositions et procédés de modulation de l épissage de SMN2 (Compositions and methods for modulation of SMN2 splicing)
Estimated Expiration: ⤷ Sign Up
Patent: 48560
Patent: Compositions et procédés pour modulation de l'épissage du SMN2 (Compositions and methods for modulation of SMN2 splicing)
Estimated Expiration: ⤷ Sign Up
Patent: 44700
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Sign Up
Patent: 70072
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 81307
Patent: 用於調節 剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING SMN2)
Estimated Expiration: ⤷ Sign Up
Patent: 47103
Patent: 調節SMN2剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 27486
Estimated Expiration: ⤷ Sign Up
Patent: 700042
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 548560
Estimated Expiration: ⤷ Sign Up
Patent: 2017037
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0046
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 10395
Estimated Expiration: ⤷ Sign Up
Patent: 48560
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 10395
Estimated Expiration: ⤷ Sign Up
Patent: 48560
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 48560
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 97113
Estimated Expiration: ⤷ Sign Up
Patent: 45223
Estimated Expiration: ⤷ Sign Up
Patent: 02531
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 9070401 | ⤷ Sign Up | |
| European Patent Office | 1436307 | ⤷ Sign Up | |
| Australia | 7747091 | ⤷ Sign Up | |
| Japan | 2711180 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPINRAZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2548560 | 2017C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
| 2548560 | C20170038 00228 | Estonia | ⤷ Sign Up | PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017 |
| 2548560 | C 2017 045 | Romania | ⤷ Sign Up | PRODUCT NAME: NUSINERSEN SAU SARURI ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1188; DATE OF NATIONAL AUTHORISATION: 20170530; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1188; DATE OF FIRST AUTHORISATION IN EEA: 20170530 |
| 2548560 | CR 2017 00055 | Denmark | ⤷ Sign Up | 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.
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