LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN - Generic Drug Details

What are the generic sources for lutetium lu-177 vipivotide tetraxetan and what is the scope of patent protection?

Lutetium lu-177 vipivotide tetraxetan is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lutetium lu-177 vipivotide tetraxetan has one hundred and thirty-two patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

International Patents:	132
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
DailyMed Link:	LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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 LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1
Novartis	PHASE1

See all LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN clinical trials

Pharmacology for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Drug Class	Radioligand Therapeutic Agent
Mechanism of Action	Radioligand Activity

US Patents and Regulatory Information for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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			Y	Y
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 LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Country	Patent Number	Title	Estimated Expiration
Poland	2187965
World Intellectual Property Organization (WIPO)	2015055318
European Patent Office	4464384	CONJUGUÉS COMPRENANT UN LIGAND DU PSMA ET UN LIEUR ET PROCÉDÉS POUR LEUR UTILISATION (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)

Supplementary Protection Certificates for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	PA2024522	Lithuania		PRODUCT NAME: LUTECIO (177LU) VIPIVOTIDO TETRAKSETANAS; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	2490022-7	Sweden		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	CA 2024 00027	Denmark		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212

Market Dynamics and Financial Trajectory for Lutetium Lu-177 VIPivotide Tetraxetan

Last updated: September 30, 2025

Introduction

Lutetium Lu-177 VIPivotide Tetraxetan (also known as 177Lu-PSMA-617) is an innovative radioligand therapy designed to target prostate-specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer (mCRPC). As a targeted radiopharmaceutical, it leverages the affinity for PSMA-expressing tumor cells to deliver localized radiation, offering a potentially transformative approach for an underserved patient population. The drug’s progression through clinical development, regulatory approval, and commercialization determines its market potential and financial trajectory.

Market Landscape and Key Drivers

Unmet Clinical Need in mCRPC

Prostate cancer remains one of the most prevalent cancers among men globally, with a substantial subset progressing to mCRPC, for which treatment options are limited after resistance to androgen deprivation therapies (ADT) and chemotherapy. The introduction of Lutetium Lu-177 VIPivotide Tetraxetan addresses this gap, offering a targeted approach with promising efficacy in extending survival and improving quality of life—as demonstrated in pivotal trials like the VISION study, which reported a median overall survival advantage of 15.3 months versus 11.3 months with standard care (Jama Oncology, 2021).

Regulatory and Reimbursement Milestones

The drug received FDA approval in March 2022 under the brand name Lutetium PSMA-617, primarily for adult patients with PSMA-positive mCRPC who have previously received androgen receptor pathway inhibitors and taxane-based chemotherapy. The European Medicines Agency (EMA) granted conditional approval in 2022. Reimbursement negotiations in major markets like the US, Europe, and Asia are ongoing, heavily influencing market penetration and revenue realization.

Competitive Landscape

While Lutetium Lu-177 VIPivotide Tetraxetan is among the first radioligand therapies targeting PSMA, competitors like Bayer’s 177Lu-PSMA-617, and other radiopharmaceuticals developing in similar spaces, threaten its market share. However, early clinical data favor the drug's positioning as a potential best-in-class option, especially if it demonstrates superior efficacy or safety profiles.

Manufacturing and Supply Chain Dynamics

Supply chain scalability for Lutetium Lu-177, a radioactive isotope with a short half-life (~6.7 days), is a critical factor limiting initial distribution. Partnerships with nuclear medicine facilities, centralized production hubs, and advances in isotope supply are crucial for meeting demand and controlling costs.

Financial Trajectory

Revenue Projections

Analysts estimate that Lutetium Lu-177 VIPivotide Tetraxetan could generate peak global sales of $750 million to over $1 billion by the late 2020s, contingent on approval expansion into earlier-line treatments and new markets (Evaluate Pharma, 2022). Initial revenues are projected to be modest in 2023-2024, as market adoption ramps up, primarily driven by patient eligibility, physician familiarity, and payer coverage.

Pricing Dynamics

Pricing strategies are influenced by the drug's therapeutic benefits, competitive landscape, and reimbursement negotiations. With comparable radioligand therapies priced around $60,000-$150,000 per treatment course in the US, Lutetium Lu-177 VIPivotide Tetraxetan is expected to command similar or slightly higher premiums, given its novel targeting mechanism and clinical benefits.

Market Penetration and Adoption

Market adoption hinges on clinical validation, physician awareness, and patient access. The FDA approval accelerates regulatory pathway, but integration into clinical practice requires educational initiatives. Early uptake in the US and Europe is anticipated to influence broader Asian and Middle Eastern markets later.

Cost of Goods and Margins

Production costs for Lutetium Lu-177 are high due to isotope procurement, specialized manufacturing, and radiolabeling processes. Margins are expected to improve as production efficiencies scale and supply chains stabilize. The company’s ability to optimize isotope supply and manufacturing processes will directly impact profitability.

Regulatory and Market Challenges

• Regulatory Delays: Additional approvals or post-marketing commitments may delay revenue streams.
• Reimbursement Hurdles: Negotiations with payers remain complex; coverage policies significantly influence patient access.
• Physician and Patient Acceptance: Education and clinical evidence will drive prescriber confidence.
• Supply Chain Constraints: Radiopharmaceutical supply chain bottlenecks could limit sales, especially in early stages.

Future Growth Opportunities

• Line Expansion: In clinical trials, Lutetium Lu-177 VIPivotide Tetraxetan is being evaluated in earlier disease settings, potentially expanding its market.
• Combination Therapies: Synergy with immunotherapies or hormonal agents could enhance efficacy, opening new avenues.
• Geographic Expansion: Asian markets and emerging regions offer substantial growth prospects as approvals are secured and pricing negotiated.
• Technological Updates: Advances in isotope production and radiolabeling techniques can reduce costs and improve product availability.

Conclusion

Lutetium Lu-177 VIPivotide Tetraxetan is poised to disrupt the mCRPC treatment landscape with its targeted radioligand mechanism. While early regulatory approval signals significant commercial potential, its long-term financial trajectory depends on successful market access, reimbursement, and clinical adoption. The evolving landscape of radiopharmaceuticals necessitates strategic positioning, supply chain robustness, and ongoing clinical validation to maximize its market impact.

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Key Takeaways

• Lutetium Lu-177 VIPivotide Tetraxetan addresses a crucial unmet need in mCRPC, with promising clinical efficacy.
• Regulatory approval in key markets accelerates commercialization prospects, but reimbursement negotiations will shape future revenues.
• Peak sales potential exceeds $1 billion worldwide, driven by expanded indications and geographic markets.
• Supply chain and manufacturing scalability are critical to ensuring consistent supply and margin optimization.
• Strategic expansion into earlier treatment lines and combination therapies could substantially enhance long-term growth.

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FAQs

1. What distinguishes Lutetium Lu-177 VIPivotide Tetraxetan from other prostate cancer therapies?
It is a targeted radioligand that selectively binds to PSMA-expressing cells, delivering localized radiation directly to tumors, unlike systemic therapies such as chemotherapy or hormone agents.

2. What are the primary regulatory milestones for this drug?
The FDA approved it in March 2022, with EMA approvals following. Future milestones include approvals in additional jurisdictions and potential label expansions based on ongoing trial data.

3. How does the supply of lutetium-177 impact the drug’s market potential?
Limited isotope supply and logistical challenges can restrict production capacity, influencing availability, timing of sales, and pricing strategies.

4. What are the main factors influencing its adoption in clinical practice?
Physician familiarity, clinical efficacy, safety profile, reimbursement policies, and supply reliability determine its integration into treatment algorithms.

5. What are the anticipated challenges in commercializing Lutetium Lu-177 VIPivotide Tetraxetan?
Key challenges include securing reimbursement, establishing reliable isotope supply, navigating competition, and expanding indications and markets to optimize revenue.

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Sources:
[1] Jama Oncology, 2021. Efficacy of 177Lu-PSMA-617 in mCRPC.
[2] Evaluate Pharma, 2022. Global oncology drug market forecasts.