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 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 December 23, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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 |
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
Sponsor | Phase |
---|---|
Biogen | Phase 4 |
Winthrop University Hospital | Early Phase 1 |
NYU Langone Health | 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 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
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 | Y | ⤷ Sign Up | |||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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
Estimated Expiration: ⤷ Sign Up
Patent: 48560
Estimated Expiration: ⤷ Sign Up
Patent: 44700
Estimated Expiration: ⤷ Sign Up
Patent: 08788
Estimated Expiration: ⤷ Sign Up
Patent: 70072
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 81307
Estimated Expiration: ⤷ Sign Up
Patent: 47103
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 |
---|---|---|---|
Japan | 3998089 | ⤷ Sign Up | |
Poland | 3449926 | ⤷ Sign Up | |
Australia | 725047 | ⤷ Sign Up | |
Canada | 2353090 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPINRAZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1910395 | 2017/051 | Ireland | ⤷ Sign Up | PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTRATION NO/DATE: EU/1/17/1188 20170530 |
2548560 | LUC00046 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
2548560 | 132017000128699 | Italy | ⤷ Sign Up | PRODUCT NAME: NUSINERSEN O SUOI SALI(SPINRAZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1188, 20170601 |
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 |