Prescription medicine

Givosiran Brand names: Givlaari

Givosiran (Givlaari) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the givosiran FDA label on DailyMed (effective September 10, 2025, Alnylam Pharmaceuticals, Inc.); the NDA 212194 record on Drugs@FDA; every givosiran label on DailyMed.

Highlights of the record

FDA label of September 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).

Forms and strengths

189 mg/ml

Injection (solution).

On the market

Earliest approval on file: November 20, 2019 Givlaari, Alnylam Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 3, 2034 Givlaari injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,462 through July 30, 2026

What is givosiran used for?

From the label: indications and usage
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP).

FDA pharmacologic class: Aminolevulinate Synthase 1-directed RNA Interaction and Small Interfering RNA.

Source: FDA drug label (GIVLAARI), Alnylam Pharmaceuticals, Inc., effective September 10, 2025 (SPL set 167e663c-11e1-497b-a3fc-951d65d58eaa), via openFDA; the full label on DailyMed

Is there a generic for givosiran (Givlaari)?

No generic givosiran is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Givlaari injection: the compound patent runs to October 3, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2019 earliest approval on file
2034 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for givosiran?

The FDA Adverse Event Reporting System holds 1,462 reports that list givosiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 47 are coded as a death and 713 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Porphyria Acute469
Hospitalisation (an outcome recorded in the report)171
Product Dose Omission Issue (a use or a product term, not a reaction)108
Nausea (named in the label)105
Intentional Dose Omission (a use or a product term, not a reaction)103
Therapy Interrupted (a use or a product term, not a reaction)100
Fatigue (named in the label)97
Pain85

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other small interfering rnas: the pharmacologic class, with prices and generics
Givosiran side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other