Viewing data from:

PLUVICTO

NDA

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN | N215833 | NOVARTIS PHARMACEUTICALS CORP

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

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2034

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2042

Today

Mar. 23, 2036

Aug. 15, 2028

Aug. 15, 2028

Nov. 12, 2035

Sep. 18, 2041

NCE

Mar. 23, 2027

I-965

Mar. 28, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)NCT07047118	Phase 2	Active	Novartis Pharmaceuticals	138	2025-07-03 → 2028-05-14
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC NCT07226986	Phase 1/2	Recruiting	Novartis Pharmaceuticals	123	2025-12-05 → 2029-09-13
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial NCT07200830	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	1,524	2026-03-31 → 2034-09-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2026	SUPPL -35	View Letter (PDF)
Apr 9, 2025	SUPPL -24	View Letter (PDF)
Apr 9, 2025	SUPPL -21	View Letter (PDF)
Mar 24, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 27mCi/ML

RLD

5 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 23, 2022

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10398791	Mar 23, 2036	—	Yes	Yes	—	—
10406240	Aug 15, 2028	—	Yes	Yes		—
11318121	Aug 15, 2028	—	Yes	Yes		—
11951190	Nov 12, 2035	—	—	—		—
12208102	Sep 18, 2041	—	—	—		—

Exclusivities (2)

Code	Date	Status
I-965	Mar 28, 2028	Active
NCE	Mar 23, 2027	< 1 year