Prescription medicine

Lumasiran Brand names: Oxlumo

Lumasiran (Oxlumo) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the lumasiran FDA label on DailyMed (effective December 1, 2025, Alnylam Pharmaceuticals, Inc.); the NDA 214103 record on Drugs@FDA; every lumasiran label on DailyMed.

Highlights of the record

FDA label of December 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1), Clinical Studies (14.1 , 14.2 , 14.3) ].

Forms and strengths

94.5 mg/.5ml

Injection (solution).

On the market

Earliest approval on file: November 23, 2020 Oxlumo, Alnylam Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: November 20, 2038 Oxlumo 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: 364 through July 30, 2026

What is lumasiran used for?

From the label: indications and usage
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1), Clinical Studies (14.1 , 14.2 , 14.3) ]. OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.

Source: FDA drug label (OXLUMO), Alnylam Pharmaceuticals, Inc., effective December 1, 2025 (SPL set 16985a31-f5e4-4557-9266-fc78d4bc5055), via openFDA; the full label on DailyMed

Is there a generic for lumasiran (Oxlumo)?

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

The Orange Book lists 14 patents for Oxlumo injection: the compound patent runs to November 20, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2020 earliest approval on file
2038 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 lumasiran?

The FDA Adverse Event Reporting System holds 364 reports that list lumasiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 126 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.

The most reported reactions

Renal Transplant49
Nephrolithiasis37
Hospitalisation (an outcome recorded in the report)21
Laboratory Test Abnormal17
Drug Ineffective (a use or a product term, not a reaction)16
Urine Oxalate Increased16
Acute Kidney Injury13
Intentional Dose Omission (a use or a product term, not a reaction)13

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?

Lumasiran side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other