Nusinersen sodium - Generic Drug Details
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What are the generic 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 |
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 | ⤷ 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 | ||||
| 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 | ||
| >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 |
|---|---|---|---|
| Hungary | E039741 | ⤷ Try a Trial | |
| Canada | 2765396 | COMPOSITIONS ET METHODES POUR MODULER L'EPISSAGE DE SMN2 CHEZ UN SUJET (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT) | ⤷ Try a Trial |
| Denmark | 3308788 | ⤷ Try a Trial | |
| Portugal | 3449926 | ⤷ Try a Trial | |
| Japan | 2022025131 | 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 | ⤷ Try a Trial |
| European Patent Office | 3449926 | COMPOSITIONS ET MÉTHODES POUR MODULER L'ÉPISSAGE DE SMN2 CHEZ UN SUJET (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT) | ⤷ 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 | LUC00046 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND 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 | 122017000100 | Germany | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/17/1188 20170530 |
| 2548560 | PA2017037 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530 |
| 2548560 | 132017000128699 | Italy | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN O SUOI SALI(SPINRAZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1188, 20170601 |
| 2548560 | C201730053 | Spain | ⤷ Try a Trial | PRODUCT NAME: NUSINERSEN O SUS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/17/1188; DATE OF AUTHORISATION: 20170530; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1188; DATE OF FIRST AUTHORISATION IN EEA: 20170530 |
| >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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