Prescription medicine

Lutetium lu 177 vipivotide tetraxetan Brand names: Pluvicto

Lutetium lu 177 vipivotide tetraxetan (Pluvicto) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the lutetium lu 177 vipivotide tetraxetan FDA label on DailyMed (effective August 12, 2026, Novartis Pharmaceuticals Corporation); the NDA 215833 record on Drugs@FDA; every lutetium lu 177 vipivotide tetraxetan label on DailyMed.

Highlights of the record

FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.

Forms and strengths

Injection (solution).

On the market

Earliest approval on file: March 23, 2022 Pluvicto, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: September 18, 2041 Pluvicto 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: 13,100 through July 30, 2026

What is lutetium lu 177 vipivotide tetraxetan used for?

From the label: indications and usage
PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. […]

Conditions named in the indications of lutetium lu 177 vipivotide tetraxetan's FDA labels, with every medicine labeled for each:

Prostate cancer

From other lutetium lu 177 vipivotide tetraxetan labels
Prostate cancer: Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated …

FDA pharmacologic class: Radioligand Therapeutic Agent.

Source: FDA drug label (PLUVICTO), Novartis Pharmaceuticals Corporation, effective August 12, 2026 (SPL set 14908037-2892-4d98-a053-253ce35afb1a), via openFDA; the full label on DailyMed

Is there a generic for lutetium lu 177 vipivotide tetraxetan (Pluvicto)?

No generic lutetium lu 177 vipivotide tetraxetan is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Pluvicto injection: the compound patent runs to March 23, 2036, and the last listed entry to September 18, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2022 earliest approval on file
2041 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 lutetium lu 177 vipivotide tetraxetan?

The FDA Adverse Event Reporting System holds 13,100 reports that list lutetium lu 177 vipivotide tetraxetan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,631 are coded as a death and 665 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 rose sharply in 2024 (3,984, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

General Physical Health Deterioration (named in the label)6,138
Ill-Defined Disorder3,636
Death (an outcome recorded in the report)1,298
Disease Progression (a use or a product term, not a reaction)340
Malignant Neoplasm Progression315
Prostatic Specific Antigen Increased268
Laboratory Test Abnormal260
Fatigue (named in the label)229

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 else is labeled for the same conditions as lutetium lu 177 vipivotide tetraxetan?

1 other medicine is given the same way (intravenous) and in the same FDA class as lutetium lu 177 vipivotide tetraxetan or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Radium ra 223 dichloride	Prostate cancer	none listed	n/a	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Lutetium lu 177 vipivotide tetraxetan side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other