Spinraza is a drug owned by Biogen Idec Inc. It is protected by 12 US drug patents filed from 2017 to 2024. Out of these, 9 drug patents are active and 3 have expired. Spinraza's patents have been open to challenges since 23 December, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 04, 2036. Details of Spinraza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8361977 | Compositions and methods for modulation of SMN2 splicing |
Dec, 2030
(6 years from now) | Active |
| US7838657 | Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences |
Jul, 2027
(2 years from now) | Active |
| US7101993 | Oligonucleotides containing 2′-O-modified purines |
Sep, 2023
(1 year, 2 months ago) |
Expired
|
| US6166197 | Oligomeric compounds having pyrimidine nucleotide (S) with 2'and 5 substitutions |
Dec, 2017
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12013403 | Compositions and methods for detection of SMN protein in a subject and treatment of a subject |
Mar, 2036
(11 years from now) | Active |
| US10436802 | Methods for treating spinal muscular atrophy |
Sep, 2035
(10 years from now) | Active |
| US9926559 | Compositions and methods for modulation of SMN2 splicing in a subject |
Jan, 2034
(9 years from now) | Active |
| US8980853 | Compositions and methods for modulation of SMN2 splicing in a subject |
Nov, 2030
(6 years from now) | Active |
| US9717750 | Compositions and methods for modulation of SMN2 splicing in a subject |
Jun, 2030
(5 years from now) | Active |
| US8110560 | Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences |
Dec, 2025
(1 year, 19 days from now) | Active |
| US10266822 | Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences |
Dec, 2025
(1 year, 19 days from now) | Active |
| US6210892 | Alteration of cellular behavior by antisense modulation of mRNA processing |
Oct, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Spinraza's patents.
Latest Legal Activities on Spinraza's Patents
Given below is the list of recent legal activities going on the following patents of Spinraza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jun, 2024 | US8361977 |
| Email Notification Critical | 21 Mar, 2024 | US9717750 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Mar, 2024 | US9717750 |
| Patent Term Extension Certificate Critical | 18 Mar, 2024 | US8361977 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Mar, 2024 | US8361977 |
| Email Notification Critical | 11 Mar, 2024 | US8361977 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 05 Mar, 2024 | US8361977 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Feb, 2024 | US10436802 |
| Email Notification Critical | 29 Feb, 2024 | US10436802 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Feb, 2024 | US9926559 |
FDA has granted several exclusivities to Spinraza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Spinraza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Spinraza.
Exclusivity Information
Spinraza holds 4 exclusivities. All of its exclusivities have expired in 2023. Details of Spinraza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-226) | May 14, 2021 |
| New Chemical Entity Exclusivity(NCE) | Dec 23, 2021 |
| Orphan Drug Exclusivity(ODE) | Dec 23, 2023 |
| Orphan Drug Exclusivity(ODE-127) | Dec 23, 2023 |
Several oppositions have been filed on Spinraza's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Spinraza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Spinraza patents.
Spinraza's Oppositions Filed in EPO
Spinraza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 19, 2019, by Taylor Wessing Llp. This opposition was filed on patent number EP17203913A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17203913A | Jun, 2019 | Taylor Wessing LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Spinraza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Spinraza's family patents as well as insights into ongoing legal events on those patents.
Spinraza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Spinraza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 04, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Spinraza Generics:
There are no approved generic versions for Spinraza as of now.
Alternative Brands for Spinraza
Spinraza which is used for treating spinal muscular atrophy in infants and adults by increasing exon-7 inclusion in SMN2 mRNA., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Genentech Inc |
| |||
About Spinraza
Spinraza is a drug owned by Biogen Idec Inc. It is used for treating spinal muscular atrophy in infants and adults by increasing exon-7 inclusion in SMN2 mRNA. Spinraza uses Nusinersen Sodium as an active ingredient. Spinraza was launched by Biogen Idec in 2016.
Can you believe Spinraza received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Spinraza was approved by FDA for market use on 23 December, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Spinraza is 23 December, 2016, its NCE-1 date is estimated to be 23 December, 2020.
Active Ingredient:
Spinraza uses Nusinersen Sodium as the active ingredient. Check out other Drugs and Companies using Nusinersen Sodium ingredient
Treatment:
Spinraza is used for treating spinal muscular atrophy in infants and adults by increasing exon-7 inclusion in SMN2 mRNA.
Dosage:
Spinraza is available in solution form for intrathecal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | SOLUTION | Prescription | INTRATHECAL |