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Generic Leqvio Availability

Last updated on Nov 7, 2023.

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

LEQVIO (inclisiran sodium - solution;subcutaneous)

  • Manufacturer: NOVARTIS
    Approval date: December 22, 2021
    Strength(s): EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) [RLD]

Has a generic version of Leqvio been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Leqvio. 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.

  • PCSK9 iRNA compositions and methods of use thereof
    Patent 10,125,369
    Issued: November 13, 2018
    Inventor(s): Borodovsky Anna & Rajeev Kallanthottathil G. & Fitzgerald Kevin & Frank-Kamenetsky Maria & Querbes William & Maier Martin & Charisse Klaus & Kuchimanchi Satyanarayana & Manoharan Muthiah & Milstein Stuart
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to RNAi agents, e.g., double-stranded RNAi agents, targeting the PCSK9 gene, and methods of using such RNAi agents to inhibit expression of PCSK9 and methods of treating subjects having a lipid disorder, such as a hyperlipidemia.

    Patent expiration dates:

    • August 18, 2034
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Glycoconjugates of RNA interference agents
    Patent 10,131,907
    Issued: November 20, 2018
    Inventor(s): Forst Andrea & Hadwiger Philipp & Vornlocher Hans-Peter
    Assignee(s): ALNYLAM PHARMACEUTICALS, INC.

    The present invention relates to agents, compositions and methods for inhibiting the expression of a target gene, comprising an RNAi agent bearing at least one galactosyl moiety. These are useful for delivering the gene expression inhibiting activity to cells, particularly hepatocytes, and more particularly in therapeutic applications.

    Patent expiration dates:

    • August 24, 2028
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
    Patent 10,266,825
    Issued: April 23, 2019
    Inventor(s): Allerson Charles & Bhat Balkrishen & Eldrup Anne B. & Manoharan Muthiah & Griffey Richard H. & Baker Brenda F. & Swayze Eric E.
    Assignee(s): Ionis Pharmaceuticals, Inc.

    The present invention provides compositions comprising at least one oligomeric compound comprising an alternating motif and further include a region that is complementary to a nucleic acid target. The compositions are useful for targeting selected nucleic acid molecules and modulating the expression of one or more genes. In preferred embodiments the compositions of the present invention hybridize to a portion of a target RNA resulting in loss of normal function of the target RNA. The present invention also provides methods for modulating gene expression.

    Patent expiration dates:

    • November 4, 2023
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
  • Therapeutic compositions
    Patent 10,273,477
    Issued: April 30, 2019
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Bumcrot David
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    This application relates to therapeutic siRNA agents and methods of making and using the agents.

    Patent expiration dates:

    • March 8, 2024
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  • Therapeutic compositions
    Patent 10,669,544
    Issued: June 2, 2020
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Bumcrot David
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    This application relates to therapeutic siRNA agents and methods of making and using the agents.

    Patent expiration dates:

    • March 8, 2024
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  • Carbohydrate conjugates as delivery agents for oligonucleotides
    Patent 10,806,791
    Issued: October 20, 2020
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Nair Jayaprakash & Maier Martin
    Assignee(s): ALNYLAM PHARMACEUTICALS, INC.

    The present invention provides a phosphorothioate-modified oligonucleotide comprising a structure shown below:

    Patent expiration dates:

    • December 4, 2028
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  • Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
    Patent 10,851,377
    Issued: December 1, 2020
    Inventor(s): Fitzgerald Kevin
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to methods of inhibiting the expression of a PCSK9 gene in a subject, as well as therapeutic and prophylactic methods for treating subjects having a lipid disorder, such as a hyperlipidemia using RNAi agents, e.g., double-stranded RNAi agents, targeting the PCSK9 gene.

    Patent expiration dates:

    • August 25, 2036
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
  • Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
    Patent 11,078,485
    Issued: August 3, 2021
    Inventor(s): Allerson Charles & Bhat Balkrishen & Eldrup Anne B. & Manoharan Muthiah & Griffey Richard H. & Baker Brenda F. & Swayze Eric E.
    Assignee(s): Ionis Pharmaceuticals, Inc.

    The present invention provides compositions comprising at least one oligomeric compound comprising an alternating motif and further include a region that is complementary to a nucleic acid target. The compositions are useful for targeting selected nucleic acid molecules and modulating the expression of one or more genes. In preferred embodiments the compositions of the present invention hybridize to a portion of a target RNA resulting in loss of normal function of the target RNA. The present invention also provides methods for modulating gene expression.

    Patent expiration dates:

    • November 4, 2023
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Patent 11,530,408
    Issued: November 30, -0001

    Patent expiration dates:

    • May 18, 2024
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  • Carbohydrate conjugates as delivery agents for oligonucleotides
    Patent 8,106,022
    Issued: January 31, 2012
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Narayanannair Jayaprakash K. & Maier Martin
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The present invention provides iRNA agents comprising at least one subunit of the formula (I):

    Patent expiration dates:

    • December 12, 2029
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Compositions and methods for inhibiting expression of the PCSK9 gene
    Patent 8,222,222
    Issued: July 17, 2012
    Inventor(s): Tan Pamela & Bramlage Birgit & Frank-Kamenetsky Maria & Fitzgerald Kevin & Akinc Akin & Kotelianski Victor E.
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to a double-stranded ribonucleic acid (dsRNA) for inhibiting the expression of the PCSK9 gene (PCSK9 gene), comprising an antisense strand having a nucleotide sequence which is less that 30 nucleotides in length, generally 19-25 nucleotides in length, and which is substantially complementary to at least a part of the PCSK9 gene. The invention also relates to a pharmaceutical composition comprising the dsRNA together with a pharmaceutically acceptable carrier; methods for treating diseases caused by PCSK9 gene expression and the expression of the PCSK9 gene using the pharmaceutical composition; and methods for inhibiting expression of a PCSK9 gene in a cell.

    Patent expiration dates:

    • December 29, 2027
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
  • RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)
    Patent 8,232,383
    Issued: July 31, 2012
    Inventor(s): McSwiggen James & Beigelman Leonid
    Assignee(s): Sirna Therapeutics, Inc.

    The present invention concerns methods and reagents useful in modulating gene expression in a variety of applications, including use in therapeutic, diagnostic, target validation, and genomic discovery applications. Specifically, the invention relates to synthetic chemically modified small nucleic acid molecules, such as short interfering nucleic acid (siNA), short interfering RNA (siRNA), double-stranded RNA (dsRNA), micro-RNA (miRNA), and short hairpin RNA (shRNA) molecules capable of mediating RNA interference (RNAi) against target nucleic acid sequences. The small nucleic acid molecules are useful in the treatment of any disease or condition that responds to modulation of gene expression or activity in a cell, tissue, or organism.

    Patent expiration dates:

    • February 20, 2023
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  • Compositions and methods for inhibiting expression of the PCSK9 gene
    Patent 8,809,292
    Issued: August 19, 2014
    Inventor(s): Tan Pamela & Bramlage Birgit & Frank-Kamenetsky Maria & Fitzgerald Kevin & Akinc Akin & Kotelianski Victor E.
    Assignee(s): Alnylam Pharmaceuticals, Inc

    The invention relates to a double-stranded ribonucleic acid (dsRNA) for inhibiting the expression of the PCSK9 gene (PCSK9 gene), comprising an antisense strand having a nucleotide sequence which is less that 30 nucleotides in length, generally 19-25 nucleotides in length, and which is substantially complementary to at least a part of the PCSK9 gene. The invention also relates to a pharmaceutical composition comprising the dsRNA together with a pharmaceutically acceptable carrier and method for treating diseases caused by PCSK9 gene expression.

    Patent expiration dates:

    • May 10, 2027
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      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Carbohydrate conjugates as delivery agents for oligonucleotides
    Patent 8,828,956
    Issued: September 9, 2014
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Jayaprakash Narayanannair K. & Maier Martin
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The present invention provides iRNA agents comprising at least one subunit of the formula (I):

    Patent expiration dates:

    • December 4, 2028
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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  • Carbohydrate conjugates as delivery agents for oligonucleotides
    Patent 9,370,582
    Issued: June 21, 2016
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Nair Jayaprakash & Maier Martin
    Assignee(s): ALNYLAM PHARMACEUTICALS, INC.

    The present invention provides iRNA agents comprising at least one subunit of the formula (I):

    Patent expiration dates:

    • December 4, 2028
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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      Drug substance
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      Drug product
  • Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
    Patent 9,708,610
    Issued: July 18, 2017
    Inventor(s): Allerson Charles & Bhat Balkrishen & Eldrup Ann B. & Manoharan Muthiah & Griffey Richard H. & Baker Brenda F. & Swayze Eric E.
    Assignee(s): Ionis Pharmaceuticals, Inc.

    The present invention provides compositions comprising at least one oligomeric compound comprising an alternating motif and further include a region that is complementary to a nucleic acid target. The compositions are useful for targeting selected nucleic acid molecules and modulating the expression of one or more genes. In preferred embodiments the compositions of the present invention hybridize to a portion of a target RNA resulting in loss of normal function of the target RNA. The present invention also provides methods for modulating gene expression.

    Patent expiration dates:

    • January 1, 2024
      ✓ 
      Patent use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
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      Drug product
  • Therapeutic compositions
    Patent 9,708,615
    Issued: July 18, 2017
    Inventor(s): Manoharan Muthiah & Rajeev Kallanthottathil G. & Bumcrot David
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    This application relates to therapeutic siRNA agents and methods of making and using the agents.

    Patent expiration dates:

    • March 8, 2024
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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:

    • December 22, 2026 - NEW CHEMICAL ENTITY

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.