Nusinersen sodium - Generic Drug Details
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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 eight 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: | 8 |
| 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nusinersen sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Chile | 2019000447 | Composiciones y métodos para detección de proteína smn en un sujeto y tratamiento de un sujeto. (divisional solicitud 201700594) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2016040748 | ⤷ Try a Trial | |
| South Korea | 20190037378 | 대상에게서 ＳＭＮ２ 스플라이싱을 조정하기 위한 조성물 및 방법 (COMPOSITION AND METHODS FOR MODULATING OF SMN2 SPLICING IN A SUBJECT) | ⤷ Try a Trial |
| Japan | 2020073498 | 被験体におけるＳＭＮ２スプライシングのモジュレーションのための組成物および方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT) | ⤷ Try a Trial |
| Lithuania | 3308788 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2014110291 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for nusinersen sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2548560 | 300902 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
| 2548560 | CA 2017 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN ELLER SALTE DERAF; REG. NO/DATE: EU/1/17/1188 20170601 |
| 2548560 | 57/2017 | Austria | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601 |
| 2548560 | 17C1048 | France | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
| 3449926 | 2020008 | Norway | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN ELLER SALTER DERAV; REG. NO/DATE: EU/1/17/1188 20170608 |
| 1910395 | 300905 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION 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.
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