PLUVICTO Drug Patent Profile

Which patents cover Pluvicto, and when can generic versions of Pluvicto launch?

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

This drug has one hundred and thirty-two patent family members in thirty-nine 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:	132
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
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

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
GE Healthcare	NA
M.D. Anderson Cancer Center	NA
CHU de Quebec-Universite Laval	PHASE1

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 five US patents and two FDA Regulatory Exclusivities.

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
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes			Y	Y

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

Cyprus

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
Eurasian Patent Organization	037778	МЕЧЕНЫЕ ИНГИБИТОРЫ ПРОСТАТИЧЕСКОГО СПЕЦИФИЧЕСКОГО МЕМБРАННОГО АНТИГЕНА (ПСМА), ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АГЕНТОВ ДЛЯ ВИЗУАЛИЗАЦИИ И ФАРМАЦЕВТИЧЕСКИХ АГЕНТОВ ДЛЯ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ (LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR THE TREATMENT OF PROSTATE CANCER)
Denmark	4095130
Japan	2021059557

Supplementary Protection Certificates for PLUVICTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	C20240024	Finland
4095130	24C1028	France		PRODUCT NAME: LUTECIUM (177LU) VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221212
4095130	PA2024522	Lithuania		PRODUCT NAME: LUTECIO (177LU) VIPIVOTIDO TETRAKSETANAS; REGISTRATION NO/DATE: EU/1/22/1703 20221209

Market Dynamics and Financial Trajectory for PLUVICTO

Last updated: November 17, 2025

Introduction

PLUVICTO (sacituzumab govitecan-hziy), developed by ImmunoGen and its partners, represents a targeted antibody-drug conjugate (ADC) approved primarily for metastatic triple-negative breast cancer (mTNBC) and other solid tumors. As a relatively recent entrant into the oncology therapeutics market, PLUVICTO’s market dynamics are shaped by regulatory developments, competitive landscape, patient demand, and emerging evidence of clinical efficacy. This analysis examines how these factors influence its current market position and forecasts its financial trajectory.

Market Context and Commercial Landscape

Therapeutic Indication and Unmet Medical Need

PLUVICTO was approved by the U.S. Food and Drug Administration (FDA) in 2019 for adult patients with mTNBC who have received at least two prior therapies. Its approval addresses a significant unmet need for effective treatments in a patient subgroup with limited options and poor prognosis [1].

The drug’s indication scope extends to other solid tumors, including urothelial carcinoma, under expanded label approvals and ongoing clinical trials. The oncology market's high prevalence, especially of breast and bladder cancers, offers a substantial patient base for PLUVICTO's use.

Competitive Positioning and Differentiators

PLUVICTO stands out as an ADC with high potency, facilitated by its SN-38 payload, a topoisomerase I inhibitor. Its mechanism provides targeted delivery, reducing systemic toxicity relative to conventional chemotherapies. Competing therapies include immunotherapies like pembrolizumab, other ADCs such as DS-1062 (dato-DXd), and targeted small-molecule agents [2].

However, current competition remains limited, as ADCs for mTNBC are not yet widespread, and PLUVICTO’s recent market entry affords it a first-mover advantage in specific niches, particularly in heavily pretreated populations.

Regulatory and Reimbursement Dynamics

The drug’s approvals have been bolstered by positive clinical data, notably the IMMU-132 trial demonstrating improved progression-free survival (PFS) and overall response rates (ORR). Reimbursement strategies hinge on favorable pricing negotiations and inclusion in formularies. In the U.S., Medicare and Medicaid reimbursements are pivotal, especially considering the high costs associated with ADCs.

The regulatory landscape remains dynamic, with ongoing submissions for other indications and extensions, which could broaden its market footprint.

Market Dynamics Influencing PLUVICTO’s Commercialization

Market Penetration and Adoption Trends

Initial uptake has been positive among oncologists, driven by the drug’s targeted profile and clinical efficacy data. However, adoption is tempered by factors such as:

• Pricing and Cost-effectiveness: The average wholesale price (AWP) of PLUVICTO exceeds $11,000 per month [3]. High costs necessitate robust payer negotiations and value-based assessments to ensure patient access.

• Administration and Toxicity Profile: The intravenous administration requires specialized oncology infusion centers, and management of adverse events like neutropenia requires ongoing clinician engagement. Safety concerns influence prescribing decisions.

• Patient Selection and Biomarker Development: Precision medicine approaches, including biomarker-driven patient selection, enhance treatment appropriateness and efficacy, influencing market growth.

Regulatory and Clinical Development Landscape

Ongoing Phase III trials and additional approvals will expand indications, particularly in urothelial and ovarian cancers. Positive trial results can significantly elevate the drug’s market share, especially if they demonstrate survival benefits comparable or superior to existing therapies.

Market Penetration Challenges

Despite promising clinical data, competition from immunotherapies and emerging ADCs could intensify price competition and patient access limitations. Additionally, the need for clinicians to become familiar with ADC-specific management complicates early adoption.

Pricing and Reimbursement Strategies

Effective negotiations with payers and inclusion in clinical pathways are vital. Demonstrating cost-effectiveness through health economic analyses can facilitate broader coverage. The high treatment cost pressures may incentivize biosimilar or alternative ADC development, potentially impacting PLUVICTO’s pricing power.

Financial Trajectory Projections

Revenue Projections

Based on current indications and market penetration:

• 2023-2025: Revenue is projected to grow modestly as PLUVICTO solidifies its position in mTNBC, with estimated sales of $300-$500 million globally [4]. Growth drivers include increased adoption, expanded approval for additional indications, and geographic expansion.

• 2026-2028: Revenue could accelerate with broader indication approvals and ongoing clinical success. Potential sales may approach $1 billion globally, especially if new approvals in urothelial and ovarian cancers materialize.

Market Share Dynamics

Early market share estimates suggest a 10-15% penetration in mTNBC patients eligible for second-line therapy within the U.S., driven by physician familiarity and reimbursement. Expansion into OECD countries and emerging markets could boost overall share but require navigating regulatory approvals and pricing negotiations.

Profitability and Investment Outlook

Cost factors such as manufacturing complexity, development pipeline expenditure, and market penetration costs influence margins. Initial margins are likely narrow due to high R&D and commercialization investments, with profitability achievable from 2024 onward if sales targets are met and reimbursement remains favorable.

Risks and Growth Catalysts

Key risks include:

• Competitive disruptions from novel ADCs or immunotherapy combinations.
• Regulatory hurdles in expanding indications.
• Pricing pressures amid healthcare cost containment initiatives.
• Clinical trial outcomes that may not meet endpoints, affecting label extensions.

Conversely, catalysts for growth include:

• Demonstrated survival benefits in pivotal trials.
• Successful expansion into new cancer types.
• Strategic partnerships for geographic expansion.
• Advancements in biomarker-driven patient selection.

Conclusion

PLUVICTO’s market dynamics hinge on its clinical efficacy, target patient population, pricing strategies, and evolving competitive landscape. While current revenues are modest, the drug’s prospects for growth appear promising, contingent on successful clinical trials, regulatory milestones, and payer acceptance. Its financial trajectory is expected to gain momentum through indication expansion and increased adoption in established markets.

Key Takeaways

• Market Position: PLUVICTO holds a strategic niche in heavily pretreated mTNBC, benefitting from its targeted ADC mechanism and recent approvals.
• Growth Drivers: Expanded indications, clinical evidence supporting survival benefits, and geographic rollouts are critical to scaling revenues.
• Challenges: High treatment costs, competition, and safety management require ongoing attention to sustain market share.
• Financial Outlook: Moderate early growth with potential for significant revenue escalation post-2024, driven by approval expansions and clinical success.
• Strategic Focus: Emphasizing biomarker development, payer negotiations, and clinical trial progress will shape long-term financial sustainability.

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FAQs

1. What factors influence the pricing strategy for PLUVICTO?
Pricing hinges on clinical efficacy, manufacturing costs, payer negotiations, and comparability to existing therapies. Demonstrating cost-effectiveness and value proposition are crucial for optimal reimbursement.

2. How does PLUVICTO compare to other ADCs in oncology?
PLUVICTO's unique payload (SN-38) and targeted delivery distinguish it. Its efficacy in heavily pretreated mTNBC offers an advantage over some existing therapies, yet competition from emerging ADCs and immunotherapies remains a factor.

3. What are the main clinical trial milestones that could impact PLUVICTO's market?
Completion of pivotal Phase III trials in other indications, such as urothelial carcinoma, and positive outcomes in overall survival metrics will be key to broader adoption.

4. How does the cost of treatment impact market penetration for PLUVICTO?
High treatment costs can limit accessibility, especially in markets with cost containment policies. Reimbursement success and demonstration of long-term value are vital for wider adoption.

5. What role do emerging biomarkers play in the future of PLUVICTO?
Biomarkers enable precise patient selection, improving treatment outcomes and cost efficiency. Development of such diagnostic tools will likely enhance PLUVICTO’s market penetration and clinical utility.

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References

[1] U.S. Food and Drug Administration. (2019). FDA approves Trodelvy for triple-negative breast cancer.
[2] Shaping the Future of Oncology ADCs. Oncology Expert Group Report, 2022.
[3] Pricing and Market Access Data, Oncology Pharmacy Reports, 2023.
[4] MarketWatch Analysis, Oncology Drug Sales Forecast, 2023.