Generic Tegsedi Availability
Last updated on Apr 10, 2025.
Tegsedi is a brand name of inotersen, approved by the FDA in the following formulation(s):
TEGSEDI (inotersen sodium - solution;subcutaneous)
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Manufacturer: AKCEA THERAPS
Approval date: October 5, 2018
Strength(s): EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tegsedi. 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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Modulation of transthyretin expression
Patent 8,101,743
Issued: January 24, 2012
Inventor(s): Brown-Driver Vickie L. & Jain Ravi
Assignee(s): Isis Pharmaceuticals, Inc.Compounds, compositions and methods are provided for modulating the expression of transthyretin. The compositions comprise oligonucleotides, targeted to nucleic acid encoding transthyretin. Methods of using these compounds for modulation of transthyretin expression and for diagnosis and treatment of diseases and conditions associated with expression of transthyretin are provided.
Patent expiration dates:
- April 1, 2025✓✓
- April 1, 2025
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Diagnosis and treatment of disease
Patent 8,697,860
Issued: April 15, 2014
Inventor(s): Monia Brett P. & Freier Susan M. & Siwkowski Andrew M. & Guo Shuling
Assignee(s): Isis Pharmaceuticals, Inc.Provided herein are methods, compounds, and compositions for reducing expression of transthyretin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate transthyretin amyloidosis, or a symptom thereof.
Patent expiration dates:
- April 29, 2031✓
- April 29, 2031
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Modulation of transthyretin expression
Patent 9,061,044
Issued: June 23, 2015
Inventor(s): Freier Susan M.
Assignee(s): Isis Pharmaceuticals, Inc.Provided herein are methods, compounds, and compositions for reducing expression of transthyretin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate transthyretin amyloidosis, or a symptom thereof.
Patent expiration dates:
- April 29, 2031✓
- April 29, 2031
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Modulation of transthyretin expression
Patent 9,399,774
Issued: July 26, 2016
Inventor(s): Monia Brett P. & Freier Susan M. & Siwkowski Andrew M. & Guo Shuling
Assignee(s): Ionis Pharmaceuticals, Inc.Provided herein are methods, compounds, and compositions for reducing expression of transthyretin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate transthyretin amyloidosis, or a symptom thereof.
Patent expiration dates:
- April 29, 2031✓
- April 29, 2031
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:
- October 5, 2025 - INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
More about Tegsedi (inotersen)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous metabolic agents
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Related treatment guides
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.