DrugPatentWatch Database Preview
SPINRAZA Drug Patent Profile
Email this page to a colleague
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 five hundred and ninety-two patent family members in thirty-two 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 May 27, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SPINRAZA
| International Patents: | 592 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 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 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 |
|---|---|
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for SPINRAZA
US Patents and Regulatory Information for SPINRAZA
SPINRAZA is protected by twenty-one US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SPINRAZA is ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it 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.
Patents protecting SPINRAZA
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
Methods for treating spinal muscular atrophy
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Oligonucleotides containing 2'-O-modified purines
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Compositions and methods for modulation of SMN2 splicing
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Compositions and methods for modulation of SMN2 splicing in a subject
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
FDA Regulatory Exclusivity protecting SPINRAZA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try it Free
TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
Exclusivity Expiration: ⤷ Try it Free
CHANGES TO THE LABELING BASED ON RESULTS FROM A CONTROLLED CLINICAL TRIAL IN PATIENTS WITH LATER-ONSET SPINAL MUSCULAR ATROPHY
Exclusivity Expiration: ⤷ Try it Free
| 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 it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it 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 | ⤷ Try it Free | ⤷ Try it Free |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPINRAZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2800848 | ⤷ Try it Free |
| Finland | 112379 | ⤷ Try it Free |
| European Patent Office | 1436308 | ⤷ Try it Free |
| European Patent Office | 0655088 | ⤷ Try it Free |
| Australia | 3653302 | ⤷ Try it Free |
| Cyprus | 1116663 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPINRAZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2548560 | LUC00046 | Luxembourg | ⤷ Try it Free | PRODUCT NAME: NUSINERSEN OU SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601 |
| 2548560 | 122017000100 | Germany | ⤷ Try it Free | PRODUCT NAME: NUSINERSEN ODER SALZE DAVON (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/17/1188 20170530 |
| 1910395 | 300905 | Netherlands | ⤷ Try it Free | PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
| 2548560 | 57/2017 | Austria | ⤷ Try it Free | PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601 |
| 2548560 | PA2017037 | Lithuania | ⤷ Try it Free | PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530 |
| 2548560 | 358 21-2017 | Slovakia | ⤷ Try it Free | PRODUCT NAME: NUSINERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1188 20170601 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
