Prescription medicine
Patisiran Brand names: Onpattro
Patisiran (Onpattro) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the patisiran FDA label on DailyMed (effective September 8, 2025, Alnylam Pharmaceuticals, Inc.); the NDA 210922 record on Drugs@FDA; every patisiran label on DailyMed.
Highlights of the record
FDA label of September 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Forms and strengths
- 2 mg/ml
Injection (lipid complex).
On the market
- Earliest approval on file
- August 10, 2018 Onpattro, Alnylam Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 27, 2035 Onpattro 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
- 2,810 through July 30, 2026
What is patisiran used for?
From the label: indications and usageONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ONPATTRO contains a transthyretin-directed small interfering RNA and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
FDA pharmacologic class: Small Interfering RNA and Transthyretin-directed RNA Interaction.
Source: FDA drug label (Onpattro), Alnylam Pharmaceuticals, Inc., effective September 8, 2025 (SPL set e87ec36f-b4b4-49d4-aea4-d4ffb09b0970), via openFDA; the full label on DailyMed
Is there a generic for patisiran (Onpattro)?
No generic patisiran is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Onpattro injection: the compound patent runs to August 27, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the patisiran label say about other medicines?
The patisiran label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | In clinical studies, all patients received premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) to reduce the risk of IRRs. |
| Vitamin a | warnings and precautions | Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur |
Source: FDA drug label (Onpattro), Alnylam Pharmaceuticals, Inc., effective September 8, 2025 (SPL set e87ec36f-b4b4-49d4-aea4-d4ffb09b0970), via openFDA; the full label on DailyMed
What do FAERS reports show for patisiran?
The FDA Adverse Event Reporting System holds 2,810 reports that list patisiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 418 are coded as a death and 1,074 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
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
- Patisiran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other