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Generic Spinraza Availability

Last updated on Nov 7, 2023.

Spinraza is a brand name of nusinersen, approved by the FDA in the following formulation(s):

SPINRAZA (nusinersen sodium - solution;intrathecal)

  • Manufacturer: BIOGEN IDEC
    Approval date: December 23, 2016
    Strength(s): EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) [RLD]

Has a generic version of Spinraza been approved?

No. There is currently no therapeutically equivalent version of Spinraza available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Spinraza. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
    Patent 10,266,822
    Issued: April 23, 2019
    Inventor(s): Singh Ravindra N. & Singh Natalia N. & Singh Nirmal K. & Androphy Elliot J.
    Assignee(s): UNIVERSITY OF MASSACHUSETTS

    The present invention is directed to methods and compositions capable of blocking the inhibitory effect of a newly-identified intronic inhibitory sequence element, named ISS-N1 (for “intronic splicing silencer”), located in the SMN2 gene. The compositions and methods of the instant invention include oligonucleotide reagents (e.g., oligoribonucleotides) that effectively target the SMN2 ISS-N1 site in the SMN2 pre-mRNA, thereby modulating the splicing of SMN2 pre-mRNA to include exon 7 in the processed transcript. The ISS-N1 blocking agents of the invention cause elevated expression of SMN protein, thus compensating for the loss of SMN protein expression commonly observed in subjects with spinal muscular atrophy (SMA).

    Patent expiration dates:

    • December 5, 2025
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
    • December 5, 2025
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
    • December 5, 2025
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
  • Methods for treating spinal muscular atrophy
    Patent 10,436,802
    Issued: October 8, 2019
    Inventor(s): Rigo Frank & Bishop Katherine M.
    Assignee(s): Biogen MA Inc.

    Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy. Also provided are kits for detecting the amount of SMN protein in a sample of cerebrospinal fluid.

    Patent expiration dates:

    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
    • September 11, 2035
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
  • Patent 7,101,993
    Issued: November 30, -0001

    Patent expiration dates:

    • September 5, 2023
      ✓ 
      Drug substance
  • Patent 7,838,657
    Issued: November 30, -0001

    Patent expiration dates:

    • July 11, 2027
      ✓ 
      Drug substance
  • SMN2
    Patent 8,110,560
    Issued: February 7, 2012
    Inventor(s): Singh Ravindra N. & Singh Natalia N. & Singh Nirmal K. & Androphy Elliot J.
    Assignee(s): University of Massachusetts

    The present invention is directed to methods and compositions capable of blocking the inhibitory effect of a newly-identified intronic inhibitory sequence element, named ISS-N1 (for “intronic splicing silencer”), located in the SMN2 gene. The compositions and methods of the instant invention include oligonucleotide reagents (e.g., oligoribonucleotides) that effectively target the SMN2 ISS-N1 site in the SMN2 pre-mRNA, thereby modulating the splicing of SMN2 pre-mRNA to include exon 7 in the processed transcript. The ISS-N1 blocking agents of the invention cause elevated expression of SMN protein, thus compensating for the loss of SMN protein expression commonly observed in subjects with spinal muscular atrophy (SMA).

    Patent expiration dates:

    • December 5, 2025
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
    • December 5, 2025
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
    • December 5, 2025
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
  • Compositions and methods for modulation of SMN2 splicing
    Patent 8,361,977
    Issued: January 29, 2013
    Inventor(s): Baker Brenda F. & Krainer Adrian R. & Hua Yimin
    Assignee(s): Isis Pharmaceuticals, Inc.

    Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a cell, tissue or animal. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy.

    Patent expiration dates:

    • May 27, 2030
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Compositions and methods for modulation of SMN2 splicing in a subject
    Patent 8,980,853
    Issued: March 17, 2015
    Inventor(s): Bennett C. Frank & Hung Gene & Rigo Frank & Krainer Adrian R. & Hua Yimin & Passini Marco A. & Shihabuddin Lamya & Cheng Seng H. & Klinger Katherine W.

    Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy.

    Patent expiration dates:

    • November 24, 2030
      ✓ 
      Patent use: TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
  • Compositions and methods for modulation of SMN2 splicing in a subject
    Patent 9,717,750
    Issued: August 1, 2017
    Inventor(s): Bennett C. Frank & Hung Gene & Rigo Frank & Krainer Adrian R. & Hua Yimin & Passini Marco A. & Shihabuddin Lamya & Cheng Seng H. & Klinger Katherine W.

    Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy.

    Patent expiration dates:

    • June 17, 2030
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
    • June 17, 2030
      ✓ 
      Patent use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
    • June 17, 2030
      ✓ 
      Patent use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
    • June 17, 2030
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
  • Compositions and methods for modulation of SMN2 splicing in a subject
    Patent 9,926,559
    Issued: March 27, 2018
    Inventor(s): Bennett C. Frank & Hung Gene & Rigo Frank
    Assignee(s): Biogen MA Inc.

    Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy.

    Patent expiration dates:

    • January 9, 2034
      ✓ 
      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • December 23, 2023 - TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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