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PlainMeds

Prescription medicine

Nedosiran Brand names: Rivfloza

Nedosiran (Rivfloza) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the nedosiran FDA label on DailyMed (effective March 3, 2025, Novo Nordisk); the NDA 215842 record on Drugs@FDA; every nedosiran label on DailyMed.

Highlights of the record

FDA label of March 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 [see Clinical Pharmacology (‎ 12.3 )], Clinical Studies (‎ 14.1 )].

Forms and strengths

  • 80 mg/.5ml
  • 128 mg/.8ml
  • 160 mg/ml

Injection (solution).

On the market

Earliest approval on file
September 29, 2023 Rivfloza, Novo; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 12, 2038 Rivfloza 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
12 through July 30, 2026

What is nedosiran used for?

From the label: indications and usage

RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 [see Clinical Pharmacology (‎ 12.3 )], Clinical Studies (‎ 14.1 )]. RIVFLOZA is an LDHA -directed small interfering RNA indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m 2 . (‎ 1 )

Source: FDA drug label (RIVFLOZA), Novo Nordisk, effective March 3, 2025 (SPL set ace9d4bc-4d20-4beb-9e9d-888690424833), via openFDA; the full label on DailyMed

Is there a generic for nedosiran (Rivfloza)?

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

The Orange Book lists 6 patents for Rivfloza injection: the compound patent runs to October 12, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2023 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 nedosiran?

The FDA Adverse Event Reporting System holds 12 reports that list nedosiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 3 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

  • Urine Oxalate Increased3
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)2
  • Rash (named in the label)2
  • Abdominal Pain1
  • Amenorrhoea1
  • Bone Pain1
  • Death (an outcome recorded in the report)1
  • Dehydration1

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

What next?

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