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Last Updated: December 22, 2024

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN - Generic Drug Details

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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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

International Patents:	108
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
DailyMed Link:	LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN at DailyMed

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

Generic Entry Date for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,398,791 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
Novartis Pharmaceuticals	Phase 3
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 2
Novartis Pharmaceuticals	Phase 2

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

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Glossary

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

International Patents for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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Country	Patent Number	Title	Estimated Expiration
Japan	6838118		⤷ Subscribe
Germany	202014011593		⤷ Subscribe
Netherlands	301281		⤷ Subscribe
Malaysia	188934	LABELED INHIBITORS OF PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA), THEIR USE AS IMAGING AGENTS AND PHARMACEUTICAL AGENTS FOR THE TREATMENT OF PROSTATE CANCER	⤷ Subscribe
Hungary	E047200		⤷ Subscribe
Japan	7079355		⤷ Subscribe
Australia	2018200419	Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	PA2024522	Lithuania	⤷ Subscribe	PRODUCT NAME: LUTECIO (177LU) VIPIVOTIDO TETRAKSETANAS; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	2024C/528	Belgium	⤷ Subscribe	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
4095130	CA 2024 00027	Denmark	⤷ Subscribe	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	301281	Netherlands	⤷ Subscribe	PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212
4095130	122024000038	Germany	⤷ Subscribe	PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	LUC00352	Luxembourg	⤷ Subscribe	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN Market Analysis and Financial Projection Experimental

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

Introduction to Lutetium Lu-177 Vipivotide Tetraxetan

Lutetium Lu-177 vipivotide tetraxetan, marketed as Pluvicto, is a groundbreaking radioligand therapeutic agent approved for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). This drug represents a significant advancement in targeted cancer therapy, leveraging the radionuclide lutetium-177 to deliver radiation directly to cancer cells.

Market Size and Growth Projections

The global market for Lutetium-177 (Lu-177) is experiencing rapid growth, driven largely by the success of lutetium Lu-177 vipivotide tetraxetan. As of 2023, the global Lu-177 market was valued at $1.59 billion and is projected to reach $5.19 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 16.21% during the forecast period of 2024-2030[1].

Regional Market Performance

North America: This region is expected to be a major contributor to the market growth, with the market estimated to increase from $1.33 billion in 2023 to $4.25 billion by 2030, at a CAGR of 15.81%[1].
Asia-Pacific: The Asia-Pacific region is also showing significant growth, with the market expected to rise from $52.29 million in 2023 to $218.65 million by 2030, at a CAGR of 20.12%[1].

Key Players and Market Share

Novartis is currently the dominant player in the Lutetium-177 market, accounting for approximately 100% of the revenue in 2023. This dominance is largely due to the approval and commercial success of lutetium Lu-177 vipivotide tetraxetan[1].

Clinical Efficacy and Market Impact

The clinical efficacy of lutetium Lu-177 vipivotide tetraxetan has been a key driver of its market success. Studies, such as the phase 3 PSMAfore trial, have shown that this drug significantly improves radiographic progression-free survival (rPFS) compared to other treatments like abiraterone acetate or enzalutamide in patients with mCRPC who are taxane naïve[5].

Cost-Effectiveness and Pricing

Despite its clinical benefits, the cost-effectiveness of lutetium Lu-177 vipivotide tetraxetan remains a significant concern. The drug is expensive, with a cost of $27,000 per vial and an estimated total treatment cost of $122,489 per patient. According to pharmacoeconomic reviews, a price reduction of 92% would be required to make the drug cost-effective at a willingness-to-pay (WTP) threshold of $50,000 per Quality-Adjusted Life Year (QALY)[2].

Regulatory Approvals and Global Reach

Lutetium Lu-177 vipivotide tetraxetan has received regulatory approvals in several regions. It was first approved by the FDA in March 2022 and later by the European Medicines Agency (EMA) in December 2022. These approvals have expanded its global reach, contributing to its market growth[3].

Revenue Performance

The drug has already achieved significant revenue milestones. For instance, Pluvicto, the brand name for lutetium Lu-177 vipivotide tetraxetan, achieved sales exceeding $950 million, highlighting its commercial success[4].

Competitive Landscape

The radioligand therapies market, which includes lutetium Lu-177 vipivotide tetraxetan, is expected to show immense growth by 2034. Other key companies in this market include Curium, Eli Lilly, Point Biopharma, and AstraZeneca. The competitive landscape is becoming more dynamic as new players and therapies enter the market[4].

Technological Trends and New Product Developments

The market is driven by continuous technological advancements and new product developments. The integration of targeting molecules with therapeutic radioisotopes, as seen in lutetium Lu-177 vipivotide tetraxetan, is a significant trend. This targeted approach enhances the efficacy and reduces the side effects of cancer treatments[4].

Industrial Chain Analysis

The industrial chain for lutetium Lu-177 includes both upstream and downstream components. The upstream involves the production of the radionuclide lutetium-177, while the downstream includes the formulation and distribution of the final product. Efficient management of this chain is crucial for maintaining supply and reducing costs[1].

Cost of Cancer Treatment

The cost of cancer treatment using lutetium Lu-177 vipivotide tetraxetan is substantial. Besides the drug itself, costs include PSMA testing and other associated medical expenses. The total treatment cost, including these additional expenses, can be significant, affecting the drug's cost-effectiveness and patient accessibility[2].

Future Prospects and Challenges

The future prospects for lutetium Lu-177 vipivotide tetraxetan are promising, given its clinical efficacy and growing market demand. However, challenges such as high costs, regulatory hurdles, and competition from other emerging therapies need to be addressed. Price adjustments and innovative pricing models may be necessary to make the drug more accessible and cost-effective.

"Lutetium Lu-177 vipivotide tetraxetan improved radiographic progression-free survival compared with abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer who were taxane naïve and experienced disease progression on a prior second-generation androgen receptor pathway inhibitor."[5]

Key Takeaways

Market Growth: The global Lu-177 market is projected to grow significantly, reaching $5.19 billion by 2030.
Clinical Efficacy: Lutetium Lu-177 vipivotide tetraxetan has shown superior rPFS compared to other treatments in clinical trials.
Cost-Effectiveness: The drug is expensive and requires significant price reductions to be cost-effective.
Regulatory Approvals: Approved by FDA and EMA, expanding its global reach.
Revenue Performance: Achieved sales exceeding $950 million.
Competitive Landscape: Part of a growing radioligand therapies market with multiple key players.

FAQs

Q: What is lutetium Lu-177 vipivotide tetraxetan used for? A: Lutetium Lu-177 vipivotide tetraxetan is used for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Q: Who are the major players in the Lutetium-177 market? A: Novartis is the dominant player, accounting for approximately 100% of the revenue in 2023.

Q: What are the projected market growth figures for Lutetium-177? A: The global Lu-177 market is expected to grow from $1.59 billion in 2023 to $5.19 billion by 2030, with a CAGR of 16.21%.

Q: How does lutetium Lu-177 vipivotide tetraxetan work? A: The drug attaches to PSMA-expressing cells and delivers radiation through the beta-minus emissions of lutetium-177, causing DNA damage and cell death.

Q: What are the cost-effectiveness challenges for lutetium Lu-177 vipivotide tetraxetan? A: The drug is expensive, requiring a price reduction of 92% to be cost-effective at a WTP threshold of $50,000 per QALY.

Sources

QYResearch: Global Lutetium-177(Lu-177) Market Research Report 2024.
NCBI: Pharmacoeconomic Review - Lutetium (177Lu) Vipivotide Tetraxetan.
DrugBank: Lutetium Lu-177 vipivotide tetraxetan.
PR Newswire: Radioligand Therapies Market to Show Immense Growth by 2034.
Onclive: Lutetium Lu 177 Vipivotide Tetraxetan Boosts rPFS in Taxane-Naïve mCRPC.

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