Generic Qalsody Availability
Last updated on Apr 10, 2025.
Qalsody is a brand name of tofersen, approved by the FDA in the following formulation(s):
QALSODY (tofersen - solution;intrathecal)
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Manufacturer: BIOGEN MA
Approval date: April 25, 2023
Strength(s): 100MG/15ML (6.7MG/ML) [RLD]
Is there a generic version of Qalsody available?
No. There is currently no therapeutically equivalent version of Qalsody available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qalsody. 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.
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Compositions for modulating SOD-1 expression
Patent 10,385,341
Issued: August 20, 2019
Inventor(s): Swayze Eric E.
Assignee(s): Biogen MA Inc.Disclosed herein are antisense compounds and methods for decreasing SOD-1 mRNA and protein expression. Such methods, compounds, and compositions are useful to treat, prevent, or ameliorate SOD-1 associated diseases, disorders, and conditions. Such SOD-1 associated diseases include amyotrophic sclerosis (ALS).
Patent expiration dates:
- April 1, 2035✓✓
- April 1, 2035
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Compositions for modulating SOD-1 expression
Patent 10,669,546
Issued: June 2, 2020
Inventor(s): Swayze Eric E.
Assignee(s): Biogen MA Inc.Disclosed herein are antisense compounds and methods for decreasing SOD-1 mRNA and protein expression. Such methods, compounds, and compositions are useful to treat, prevent, or ameliorate SOD-1 associated diseases, disorders, and conditions. Such SOD-1 associated diseases include amyotrophic sclerosis (ALS).
Patent expiration dates:
- April 1, 2035✓
- April 1, 2035
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Compositions for modulating SOD-1 expression
Patent 10,968,453
Issued: April 6, 2021
Inventor(s): Swayze Eric E.
Assignee(s): Biogen MA Inc.Disclosed herein are antisense compounds and methods for decreasing SOD-1 mRNA and protein expression. Such methods, compounds, and compositions are useful to treat, prevent, or ameliorate SOD-1 associated diseases, disorders, and conditions. Such SOD-1 associated diseases include amyotrophic sclerosis (ALS).
Patent expiration dates:
- April 1, 2035✓
- April 1, 2035
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:
- April 25, 2028 - NEW CHEMICAL ENTITY
- April 25, 2030 - TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE
More about Qalsody (tofersen)
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- Drug class: miscellaneous central nervous system agents
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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.
