PLUVICTO Drug Patent Profile

When do Pluvicto patents expire, and when can generic versions of Pluvicto launch?

Pluvicto is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and eleven patent family members in thirty-five countries.

The generic ingredient in PLUVICTO is lutetium lu-177 vipivotide tetraxetan. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu-177 vipivotide tetraxetan profile page.

DrugPatentWatch^® Generic Entry Outlook for Pluvicto

Pluvicto will be eligible for patent challenges on March 23, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PLUVICTO

International Patents:	111
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for PLUVICTO
What excipients (inactive ingredients) are in PLUVICTO?	PLUVICTO excipients list
DailyMed Link:	PLUVICTO at DailyMed

See drug prices for PLUVICTO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PLUVICTO

Constraining patent/regulatory exclusivity:

10,398,791

NDA:

215833

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PLUVICTO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
VA Office of Research and Development	Phase 2
OncoC4, Inc.	Phase 2
Prostate Cancer Clinical Trials Consortium	Phase 2

See all PLUVICTO clinical trials

Pharmacology for PLUVICTO

Drug Class	Radioligand Therapeutic Agent
Mechanism of Action	Radioligand Activity

US Patents and Regulatory Information for PLUVICTO

PLUVICTO is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,398,791.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes	11,318,121		Y	Y
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes	10,398,791		Y	Y
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes	10,406,240		Y	Y
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes	11,951,190
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes

International Patents for PLUVICTO

When does loss-of-exclusivity occur for PLUVICTO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Georgia, Republic of

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PLUVICTO around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	194484	LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR THE TREATMENT OF PROSTATE CANCER
New Zealand	718812
Spain	2977715
Portugal	2187965
Japan	2018150350	ＰＳＭＡ結合性リガンド−リンカー結合体及び使用方法 (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)
Japan	2016153410	ＰＳＭＡ結合性リガンド−リンカー結合体及び使用方法 (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)

Supplementary Protection Certificates for PLUVICTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	CA 2024 00027	Denmark		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	2024C/528	Belgium		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
4095130	PA2024522	Lithuania		PRODUCT NAME: LUTECIO (177LU) VIPIVOTIDO TETRAKSETANAS; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	CR 2024 00027	Denmark		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	122024000038	Germany		PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	LUC00352	Luxembourg		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212

Market Dynamics and Financial Trajectory for Pluvicto

Introduction

Pluvicto, also known as lutetium (177Lu) vipivotide tetraxetan, is a radioligand therapy (RLT) developed by Novartis for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This therapy has garnered significant attention due to its promising clinical outcomes and robust market performance.

Clinical Significance of Pluvicto

Pluvicto targets the prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells. The drug has shown substantial clinical benefits, particularly in improving imaging-based progression-free survival (PFS) and overall survival (OS) in patients with mCRPC. The Phase III VISION trial demonstrated that Pluvicto more than doubled the median PFS compared to standard-care treatments, with a median PFS of 8.7 months versus 3.4 months for standard care. Additionally, patients receiving Pluvicto had a median four-month increase in OS[1].

Market Growth and Projections

The market for radiopharmaceuticals in prostate cancer is expected to experience significant growth, driven largely by the success of Pluvicto. GlobalData forecasts that the global revenue of Pluvicto will rise from $980 million in 2023 to $4.3 billion by 2030, making it a blockbuster drug in the nuclear medicine sector[1].

Sales Performance

In the third quarter of 2024, Pluvicto generated $386 million in sales, representing a 50% year-over-year growth, although this figure was slightly inflated by a one-time revenue adjustment in Europe. Without this adjustment, the sales growth would have been around 36%, still a notable increase but short of some expectations[4].

Competitive Landscape

Pluvicto currently dominates the market for radioligand therapies in prostate cancer, with no immediate threats to its market share. Other drugs, such as Eli Lilly's lutetium (177Lu) zadavotide guraxetan, are in development but face significant hurdles before they can challenge Pluvicto's position. GlobalData predicts that lutetium (177Lu) zadavotide guraxetan will achieve global sales of $1.65 billion by 2030, but its clinical approval is still pending[1].

Financial Trajectory of Novartis

Novartis, the parent company of Pluvicto, has seen strong financial performance in recent quarters. In Q3 2024, Novartis reported net sales of $12.8 billion, a 9% increase year-over-year, with core operating income growing by 20% to $5.1 billion. The company's free cash flow also increased by 18% to $6.0 billion, driven by higher net cash flows from operating activities[2][5].

Impact of Pluvicto on Novartis' Financials

Pluvicto is a key growth driver for Novartis, contributing significantly to the company's revenue and profitability. Despite some initial disappointment in Q3 sales due to high expectations, Pluvicto's growth trajectory remains robust. Novartis has upgraded its full-year guidance for net sales and core operating income, reflecting the company's optimism about its business, including the performance of Pluvicto[4][5].

Commercial and Business Aspects

The commercial success of Pluvicto and another radioligand therapy, Lutathera, has sparked significant interest and investment in the field of nuclear medicine. Novartis' acquisition of Advanced Accelerator Applications (AAA) and Endocyte has been pivotal in expanding its presence in this sector. Analysts predict that Pluvicto's sales could reach $1 billion annually, with additional upside potential from further approvals and expanded indications[3].

Expansion and Future Indications

Pluvicto is currently under evaluation for expanded indications, including pre-chemotherapy settings in mCRPC and treatment-naive metastatic prostate cancer. Successful outcomes from these trials could drive a 2-3 times increase in currently modeled sales, further solidifying Pluvicto's blockbuster potential[3].

Regulatory Milestones

Novartis has made significant strides in regulatory approvals for Pluvicto. The drug has received FDA approval for the treatment of mCRPC patients previously treated with androgen deprivation therapy (ADT) and taxane chemotherapy. Additionally, Novartis is pursuing further regulatory filings, including the PSMAfore filing in the US, to expand Pluvicto's market reach[1][5].

Investor and Market Sentiment

The strong performance of Pluvicto has been well-received by investors, despite some short-term fluctuations. Novartis' overall financial health and the growth potential of its pipeline, including Pluvicto, have maintained investor confidence. The company's stock performance reflects this optimism, with Novartis continuing to raise its full-year guidance for net sales and core operating income[2][4].

Key Takeaways

• Clinical Success: Pluvicto has demonstrated significant clinical benefits in treating mCRPC, improving PFS and OS.
• Market Growth: Forecasted to reach $4.3 billion in sales by 2030, making it a blockbuster drug.
• Financial Performance: Strong contribution to Novartis' revenue and profitability, with ongoing growth expected.
• Regulatory Milestones: FDA approval and ongoing regulatory filings to expand indications.
• Commercial Potential: Additional upside from expanded indications and further approvals.

FAQs

Q: What is Pluvicto and how does it work?

A: Pluvicto, or lutetium (177Lu) vipivotide tetraxetan, is a radioligand therapy that targets the prostate-specific membrane antigen (PSMA) on prostate cancer cells, delivering targeted radiation to treat metastatic castration-resistant prostate cancer (mCRPC).

Q: What are the clinical benefits of Pluvicto?

A: Pluvicto has shown significant improvements in imaging-based progression-free survival (PFS) and overall survival (OS) in patients with mCRPC, with a median PFS more than doubling compared to standard-care treatments.

Q: What are the sales projections for Pluvicto?

A: GlobalData forecasts that Pluvicto's global revenue will rise from $980 million in 2023 to $4.3 billion by 2030.

Q: How does Pluvicto impact Novartis' financials?

A: Pluvicto is a key growth driver for Novartis, contributing significantly to the company's revenue and profitability, and has helped in raising Novartis' full-year guidance for net sales and core operating income.

Q: What are the future indications and potential for Pluvicto?

A: Pluvicto is under evaluation for expanded indications, including pre-chemotherapy settings in mCRPC and treatment-naive metastatic prostate cancer, which could further increase its sales potential.

Sources

1. GlobalData: "Radiopharmaceuticals for prostate cancer to go nuclear with $6.3 billion in sales by 2030, forecasts GlobalData"[1].
2. Novartis: "Novartis continues strong momentum in Q3 with 10% sales growth and 20% core operating income growth"[2].
3. Frontiers in Medicine: "Commercial and business aspects of alpha radioligand therapeutics"[3].
4. BioSpace: "Novartis Gets Q3 Beat on Strong Cosentyx Sales, But Pluvicto Disappoints"[4].
5. Novartis Financial Results Q3 2024: "Novartis Financial Results Q3 2024 – English"[5].