DrugPatentWatch Database Preview
SPINRAZA Drug Profile
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 eight patents protecting this drug.
This drug has five hundred and sixty-seven patent family members in twenty-nine 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.
Summary for SPINRAZA
| International Patents: | 567 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for SPINRAZA |
| DailyMed Link: | SPINRAZA at DailyMed |
Generic Entry Opportunity 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 |
|---|---|
| Winthrop University Hospital | Early Phase 1 |
| NYU Langone Health | Early Phase 1 |
Pharmacology for SPINRAZA
| Drug Class | Survival Motor Neuron-2-directed RNA Interaction Antisense Oligonucleotide |
| Physiological Effect | Increased Protein Synthesis |
US Patents and Regulatory Information for SPINRAZA
| 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 | See Pricing | See Pricing | See Pricing | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| >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 | See Pricing | See Pricing |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPINRAZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 7007198 | See Pricing |
| China | 102665731 | See Pricing |
| European Patent Office | 1910395 | See Pricing |
| Canada | 2443641 | See Pricing |
| Brazil | 9406931 | See Pricing |
| Denmark | 0618925 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPINRAZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2548560 | 300902 | Netherlands | See Pricing | PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
| 2548560 | PA2017037,C2548560 | Lithuania | See Pricing | PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530 |
| 2548560 | C201730053 | Spain | See Pricing | 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 |
| 1910395 | 2017C/047 | Belgium | See Pricing | PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
| 2548560 | 57/2017 | Austria | See Pricing | PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601 |
| 2548560 | 2017C/048 | Belgium | See Pricing | PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
