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 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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Questions you can ask:
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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
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 |
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 ⤷ Try for Free.
This potential generic entry date is based on patent 8,361,977.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,110,560 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 9,926,559 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 8,980,853 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 9,717,750 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 10,266,822 | ⤷ Try for Free | ⤷ Try for 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 | 6,166,197 | ⤷ Try for Free |
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 6,210,892 | ⤷ Try for Free |
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 7,101,993 | ⤷ Try for Free |
>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 for Free
Patent: 21134
Estimated Expiration: ⤷ Try for Free
Patent: 17040
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 10395
Estimated Expiration: ⤷ Try for Free
Patent: 48560
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Patent: 48560
Patent: Compositions et procédés pour modulation de l'épissage du SMN2 (Compositions and methods for modulation of SMN2 splicing)
Estimated Expiration: ⤷ Try for Free
Patent: 44700
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Try for Free
Patent: 70072
Patent: COMPOSITIONS ET PROCÉDÉS POUR MODULATION DE L'ÉPISSAGE DU SMN2 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Hungary
Patent: 27486
Estimated Expiration: ⤷ Try for Free
Patent: 700042
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 548560
Estimated Expiration: ⤷ Try for Free
Patent: 2017037
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Estimated Expiration: ⤷ Try for Free
Luxembourg
Patent: 0046
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 10395
Estimated Expiration: ⤷ Try for Free
Patent: 48560
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 10395
Estimated Expiration: ⤷ Try for Free
Patent: 48560
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 48560
Estimated Expiration: ⤷ Try for Free
Patent: 08788
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 97113
Estimated Expiration: ⤷ Try for Free
Patent: 45223
Estimated Expiration: ⤷ Try for Free
Patent: 02531
Estimated Expiration: ⤷ Try for 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.
See the table below for additional patents covering SPINRAZA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 921850 | ⤷ Try for Free | |
Australia | 763066 | ⤷ Try for Free | |
Australia | 662538 | ⤷ Try for Free | |
Australia | 668604 | ⤷ Try for Free | |
Mexico | 2011014004 | COMPOSICIONES Y METODOS PARA LA MODULACION DE DIVISION DE SMN2 EN UN SUJETO. (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT.) | ⤷ Try for Free |
>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 | ⤷ Try for Free | PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
1910395 | 132017000128668 | Italy | ⤷ Try for Free | PRODUCT NAME: NUSINERSEN O SUOI SALI(SPINRAZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1188, 20170601 |
2548560 | LUC00046 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
2548560 | C02548560/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: NUSINERSEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66495 20.09.2017 |
2548560 | 122017000100 | Germany | ⤷ Try for Free | PRODUCT NAME: NUSINERSEN ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/17/1188 20170530 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of SPINRAZA
More… ↓