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Generic Spinraza Availability

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): 12MG/5ML (2.4MG/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 FAQs.

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.

  • Alteration of cellular behavior by antisense modulation of mRNA processing
    Patent 6,210,892
    Issued: April 3, 2001
    Inventor(s): Bennett; C. Frank & Cooke; Stanley T. & Manoharan; Muthiah & Wyatt; Jacqueline R. & Baker; Brenda F. & Monia; Brett P. & Freier; Susan M. & McKay; Robert & Karras; James G.
    Assignee(s): Isis Pharmaceuticals, Inc.

    The present invention provides compositions and methods for controlling the behavior of a cell, tissue or organism through antisense modulation of mRNA processing, using antisense compounds which does not support cleavage of the mRNA target.

    Patent expiration dates:

    • October 7, 2018
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
  • Oligonucleotides containing 2′-O-modified purines
    Patent 7,101,993
    Issued: September 5, 2006
    Inventor(s): Cook; Phillip Dan & McGee; Daniel Peter Claude & Guinosso; Charles John
    Assignee(s): ISIS Pharmaceuticals, Inc.

    Compounds are provided containing purine nucleotides that bear moieties X at the 2′ position thereof wherein X is R1—(R2)n; R1 is C3-C20 alkyl, C4-C20 alkenyl or C2-C20 alkynyl; R2 is halogen, hydroxyl, thiol, keto, carboxyl, nitro, nitroso, nitrile, trifluoromethyl, trifluoromethoxy, O-alkyl, S-alkyl, NH-alkyl, N-dialkyl, O-aryl, S-aryl, NH-aryl, O-aralkyl, S-aralkyl, NH-aralkyl, amino, N-phthalimido, imidazole, azido, hydrazino, hydroxylamino, isocyanato, sulfoxide, sulfone, sulfide, disulfide, silyl, aryl, heterocycle, carbocycle, intercalator, reporter molecule, conjugate, polyamine, polyamide, polyalkylene glycol, polyether, a group that enhances the pharmacodynamic properties of oligonucleotides, or a group that enhances the pharmacokinetic properties of oligonucleotides; and n is an integer from 0 to about 6. Such compounds are useful for modulating the synthesis of proteins.

    Patent expiration dates:

    • September 5, 2023
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      Drug substance
  • Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
    Patent 7,838,657
    Issued: November 23, 2010
    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:

    • July 11, 2027
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      Drug substance
  • Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
    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
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
    • December 5, 2025
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
    • December 5, 2025
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE
  • Compositions and methods for modulation of SMN2 splicing
    Patent 8,361,977
    Issued: January 29, 2013
    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
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      Drug substance
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      Drug product
  • Compositions and methods for modulation of SMN2 splicing in a subject
    Patent 8,980,853
    Issued: March 17, 2015
    Assignee(s): Isis Pharmaceuticals, Inc. Cold Spring Harbor Laboratory

    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
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      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
    Assignee(s): Biogen MA Inc. Cold Spring Harbor Laboratory

    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
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
    • June 17, 2030
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      Patent use: TREATMENT OF SPINAL MUSCULAR ATROPHY
    • June 17, 2030
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      Patent use: TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
    • June 17, 2030
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      Patent use: TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
  • Compositions and methods for modulation of SMN2 splicing in a subject
    Patent 9,926,559
    Issued: March 27, 2018
    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
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      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:

    • May 14, 2021 - CHANGES TO THE LABELING BASED ON RESULTS FROM A CONTROLLED CLINICAL TRIAL IN PATIENTS WITH LATER-ONSET SPINAL MUSCULAR ATROPHY
    • December 23, 2021 - NEW CHEMICAL ENTITY
    • December 23, 2023 -

Further information

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

Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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