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Generic Kynamro Availability

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

KYNAMRO (mipomersen sodium - solution;subcutaneous)

  • Manufacturer: KASTLE THERAPS LLC
    Approval date: January 29, 2013
    Strength(s): 200MG/ML (200MG/ML) [RLD]

Has a generic version of Kynamro been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kynamro. 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: About generic drugs.

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.

  • Oligomeric compounds having pyrimidine nucleotide (S) with 2'and 5 substitutions
    Patent 6,166,197
    Issued: December 26, 2000
    Inventor(s): Cook; Phillip Dan & Sanghvi; Yogesh S. & Sprankle; Kelly G. & Ross; Bruce S. & Griffey; Rich H.
    Assignee(s): ISIS Pharmaceuticals, Inc.
    Oligonucleotide analogs are disclosed having pyrimidine monomeric sub-units therein that are modified at the 2' and 5 positions. Monomeric sub-units having these modifications may be further modified at the 2 position.
    Patent expiration dates:
    • December 26, 2017
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      Drug substance
  • Sugar-modified gapped oligonucleotides
    Patent 6,451,991
    Issued: September 17, 2002
    Inventor(s): Pierre; Martin & Karl-Heinz; Altmann & Phillip Dan; Cook & Brett P.; Monia
    Assignee(s): ISIS Pharmaceuticals, Inc. Novartis AG
    Oligonucleotides are provided which have increased nuclease resistance, substituent groups for increasing binding affinity to complementary nucleic acid strand, and subsequences of 2′-deoxy-erythro-pentofuranosyl nucleosides that activate RNase H. Such oligonucleotides 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 ooligonucleotide therapeutics.
    Patent expiration dates:
    • February 11, 2017
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      Drug substance
  • 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
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      Drug substance
  • Antisense modulation of apolipoprotein B expression
    Patent 7,407,943
    Issued: August 5, 2008
    Inventor(s): Crooke; Rosanne M. & Graham; Mark J.
    Assignee(s): ISIS Pharmaceuticals, Inc.
    Antisense compounds, compositions and methods are provided for modulating the expression of apolipoprotein B. The compositions comprise antisense compounds, particularly antisense oligonucleotides, targeted to nucleic acids encoding apolipoprotein B. Methods of using these compounds for modulation of apolipoprotein B expression and for treatment of diseases associated with expression of apolipoprotein B are provided.
    Patent expiration dates:
    • August 1, 2021
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      Patent use: ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY LIPOPROTEIN-CHOLESTEROL, APOLIPOPROTEIN B, TOTAL CHOLESTEROL, AND NON-HIGH DENSITY LIPOPROTEIN CHOLESTEROL IN PTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
  • Antisense modulation of apolipoprotein B expression
    Patent 7,511,131
    Issued: March 31, 2009
    Inventor(s): Crooke; Roseanne M. & Graham; Mark & Freier; Susan M.
    Assignee(s): Genzyme Corporation
    Antisense compounds, compositions and methods are provided for modulating the expression of apolipoprotein B. The compositions comprise antisense compounds, particularly antisense oligonucleotides, targeted to nucleic acids encoding apolipoprotein B. Methods of using these compounds for modulation of apolipoprotein B expression and for treatment of diseases associated with expression of apolipoprotein B are provided.
    Patent expiration dates:
    • December 13, 2025
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      Drug substance

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:
    • January 29, 2018 - NEW CHEMICAL ENTITY
    • January 29, 2020 - ORPHAN DRUG EXCLUSIVITY

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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