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Generic Tegsedi Availability

Last updated on Sep 8, 2021.

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

TEGSEDI (inotersen sodium - solution;subcutaneous)

  • Manufacturer: AKCEA THERAPS
    Approval date: October 5, 2018
    Strength(s): EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) [RLD]

Has a generic version of Tegsedi been approved?

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

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.

  • Gapped oligonucleotides
    Patent 7,015,315
    Issued: March 21, 2006
    Inventor(s): Cook; Phillip Dan & Monia; Brett P.
    Assignee(s): ISIS Pharmaceuticals, Inc.

    Oligonucleotides and other macromolecules are provided which have increased nuclease resistance, substituent groups for increasing binding affinity to complementary strand, and subsequences of 2′-deoxy-erythro-pentofuranosyl nucleotides that activate RNase H. Such oligonucleotides and macromolecules are useful for diagnostics and other research purposes, for modulating the expression of a protein in organisms, and for the diagnosis, detection and treatment of other conditions susceptible to oligonucleotide therapeutics.

    Patent expiration dates:

    • March 21, 2023
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      Drug substance
  • 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
      ✓ 
      Drug substance
  • 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
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Diagnosis and treatment of disease
    Patent 8,697,860
    Issued: April 15, 2014
    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
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      Drug product
  • Modulation of transthyretin expression
    Patent 9,061,044
    Issued: June 23, 2015
    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
      ✓ 
      Drug substance
  • Modulation of transthyretin expression
    Patent 9,399,774
    Issued: July 26, 2016
    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
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS

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, 2023 - NEW CHEMICAL ENTITY
    • October 5, 2025 -

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.