Generic Givlaari Availability
Last updated on Oct 9, 2024.
Givlaari is a brand name of givosiran, approved by the FDA in the following formulation(s):
GIVLAARI (givosiran sodium - solution;subcutaneous)
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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.
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Compositions and methods for inhibiting expression of the ALAS1 gene
Patent 10,119,143
Issued: November 6, 2018
Inventor(s): Bettencourt Brian & Fitzgerald Kevin & Querbes William & Desnick Robert J. & Yasuda MakikoThe 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✓✓✓
- October 3, 2034
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Compositions and methods for inhibiting expression of the ALAS1 gene
Patent 10,125,364
Issued: November 13, 2018
Inventor(s): Bettencourt Brian & Fitzgerald Kevin & Querbes William & Desnick Robert J. & Yasuda MakikoThe 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✓✓✓
- March 15, 2033
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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✓✓✓
- August 24, 2028
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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✓
- March 8, 2024
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Compositions and methods for inhibiting expression of the ALAS1 gene
Patent 11,028,392
Issued: June 8, 2021
Inventor(s): Bettencourt Brian & Fitzgerald Kevin & Querbes William & Desnick Robert J. & Yasuda MakikoThe 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✓✓✓
- October 3, 2034
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Patent 11,530,408
Patent expiration dates:
- May 18, 2024✓✓
- 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✓✓✓
- December 12, 2029
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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✓✓✓
- December 4, 2028
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Compositions and methods for inhibiting expression of the ALAS1 gene
Patent 9,133,461
Issued: September 15, 2015
Inventor(s): Bettencourt Brian & Fitzgerald Kevin & Querbes William & Desnick Robert J. & Yasuda MakikoThe 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:
- November 30, 2033✓✓✓
- November 30, 2033
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Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
Patent 9,150,605
Issued: October 6, 2015
Inventor(s): Allerson Charles & Bhat Balkrishen & Eldrup Anne B. & Manoharan Muthiah & Griffey Richard H. & Baker Brenda F. & Swayze Eric E.
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✓✓
- 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
Inventor(s): Bettencourt Brian & Fitzgerald Kevin & Querbes William & Yasuda Makiko & Desnick Robert J.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✓
- March 15, 2033
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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✓
- March 8, 2024
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 - INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)
More about Givlaari (givosiran)
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Glossary
Term | Definition |
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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.