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Generic Givlaari Availability

Last updated on July 7, 2021.

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

GIVLAARI (givosiran sodium - solution;subcutaneous)

  • Manufacturer: ALNYLAM PHARMS INC
    Approval date: November 20, 2019
    Strength(s): EQ 189MG BASE/ML (EQ 189MG BASE/ML) [RLD]

Has a generic version of Givlaari been approved?

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

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

  • Compositions and methods for inhibiting expression of the ALAS1 gene
    Patent 10,119,143
    Issued: November 6, 2018
    Assignee(s): ALNYLAM PHARMACEUTICALS, INC. ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

    The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.

    Patent expiration dates:

    • October 3, 2034
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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      Drug product
  • Compositions and methods for inhibiting expression of the ALAS1 gene
    Patent 10,125,364
    Issued: November 13, 2018
    Assignee(s): ALYNYLAM PHARMACEUTICALS, INC. ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

    The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.

    Patent expiration dates:

    • March 15, 2033
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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  • Glycoconjugates of RNA interference agents
    Patent 10,131,907
    Issued: November 20, 2018
    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: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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  • Therapeutic compositions
    Patent 10,273,477
    Issued: April 30, 2019
    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
  • 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): wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, —P(Z′)(Z″)O-nucleoside, —P(Z′)(Z″)O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, —P(Z′)(Z″)O-Linker-OP(Z′″)(Z″″)O-oligonucleotide, a nucleotide, an oligonucleotide, —P(Z′)(Z″)-formula (I), —P(Z′)(Z″)— or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; RN is independently for each occurrence H, methyl, ethyl, propyl, isopropyl, butyl, or benzyl; and Z′, Z″, Z′″ and Z″″ are each independently for each occurrence O or S.

    Patent expiration dates:

    • December 12, 2029
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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  • Compositions and methods for inhibiting expression of a target gene
    Patent 8,546,143
    Issued: October 1, 2013
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The present invention relates to a double-stranded ribonucleic acid (dsRNA) having a nucleotide sequence which is substantially identical to at least a part of a target gene and which is no more than 49, preferably less than 25, nucleotides in length, and which comprises a complementary (antisense) RNA strand having a 1 to 4 nucleotide overhang at the 3′-end and a blunt 5′-end. The invention further relates to a pharmaceutical composition comprising the dsRNA and a pharmaceutically acceptable carrier. The pharmaceutical compositions are useful for inhibiting the expression of a target gene, as well as for treating diseases caused by expression of the target gene, at low dosages (i.e., less than 5 milligrams, preferably less than 25 micrograms, per kg body weight per day). The invention also relates to methods for inhibiting the expression of a target gene, as well as methods for treating diseases caused by the expression of the gene.

    Patent expiration dates:

    • January 9, 2022
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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  • Carbohydrate conjugates as delivery agents for oligonucleotides
    Patent 8,828,956
    Issued: September 9, 2014
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The present invention provides iRNA agents comprising at least one subunit of the formula (I): wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, —P(Z′)(Z″)O-nucleoside, —P(Z′)(Z″)O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, —P(Z′)(Z″)O-Linker-OP(Z′″)(Z″″)O-oligonucleotide, a nucleotide, an oligonucleotide, —P(Z′)(Z″)-formula (I), —P(Z′)(Z″)— or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; RN is independently for each occurrence H, methyl, ethyl, propyl, isopropyl, butyl, or benzyl; and Z′, Z″, Z′″ and Z″″ are each independently for each occurrence O or S.

    Patent expiration dates:

    • December 4, 2028
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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      Drug product
  • Compositions and methods for inhibiting expression of the ALAS1 gene
    Patent 9,133,461
    Issued: September 15, 2015
    Assignee(s): Alnylam Pharmaceuticals, Inc. Icahn School of Medicine at Mount Sinai

    The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.

    Patent expiration dates:

    • May 14, 2033
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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  • Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
    Patent 9,150,605
    Issued: October 6, 2015
    Assignee(s): Isis 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:

    • August 28, 2025
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  • Compositions and methods for inhibiting expression of the ALAS1 gene
    Patent 9,631,193
    Issued: April 25, 2017
    Assignee(s): ALNYLAM PHARMACEUTICALS, INC. ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

    The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.

    Patent expiration dates:

    • March 15, 2033
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
  • Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
    Patent 9,708,610
    Issued: July 18, 2017
    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
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      Patent use: TREATMENT OF ACUTE HEPATIC PORPHYRIA
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      Drug substance
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      Drug product
  • Therapeutic compositions
    Patent 9,708,615
    Issued: July 18, 2017
    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:

    • November 20, 2024 - NEW CHEMICAL ENTITY
    • November 20, 2026 -

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.