Nusinersen sodium - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for nusinersen sodium and what is the scope of patent protection?
Nusinersen sodium
is the generic ingredient in one branded drug marketed by Biogen Idec and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nusinersen sodium has one hundred and two patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for nusinersen sodium
| International Patents: | 102 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | nusinersen sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nusinersen sodium
Generic Entry Date for nusinersen sodium*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for nusinersen sodium
| Drug Class | Antisense Oligonucleotide Survival Motor Neuron-2-directed RNA Interaction |
| Physiological Effect | Increased Protein Synthesis |
Anatomical Therapeutic Chemical (ATC) Classes for nusinersen sodium
US Patents and Regulatory Information for nusinersen sodium
| 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 | 7,838,657 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 8,110,560 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 8,361,977 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 8,980,853 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 9,926,559 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | 12,013,403 | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 nusinersen sodium
| 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 | ⤷ Subscribe |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 7,101,993 | ⤷ Subscribe |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 6,210,892 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nusinersen sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1120807 | ⤷ Subscribe | |
| China | 115227709 | 用于在对象中调节SMN2剪接的组合物和方法 (Compositions and methods for modulating SMN2 splicing in subject) | ⤷ Subscribe |
| Turkey | 201816256 | ⤷ Subscribe | |
| Russian Federation | 2012101491 | КОМПОЗИЦИИ И СПОСОБЫ МОДУЛЯЦИИ SMN2 СПЛАЙСИНГА У СУБЪЕКТА | ⤷ Subscribe |
| Cyprus | 2017040 | ⤷ Subscribe | |
| China | 102665731 | Compositions and methods for modulation of SMN2 splicing in a subject | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for nusinersen sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2548560 | 2017C/048 | Belgium | ⤷ Subscribe | PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
| 2548560 | 57/2017 | Austria | ⤷ Subscribe | PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601 |
| 2548560 | C 2017 045 | Romania | ⤷ Subscribe | 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 |
| 1910395 | 2017/051 | Ireland | ⤷ Subscribe | PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTRATION NO/DATE: EU/1/17/1188 20170530 |
| 2548560 | C20170038 00228 | Estonia | ⤷ Subscribe | PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017 |
| 1910395 | CA 2017 00054 | Denmark | ⤷ Subscribe | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
