ILLUCCIX Drug Patent Profile

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

Illuccix is a drug marketed by Telix and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in eighteen countries.

The generic ingredient in ILLUCCIX is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

DrugPatentWatch^® Generic Entry Outlook for Illuccix

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 28, 2035. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ILLUCCIX

International Patents:	45
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Applications:	84
Drug Prices:	Drug price information for ILLUCCIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILLUCCIX
What excipients (inactive ingredients) are in ILLUCCIX?	ILLUCCIX excipients list
DailyMed Link:	ILLUCCIX at DailyMed

See drug prices for ILLUCCIX

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

NDA:

214032

Dosage:

POWDER;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 ILLUCCIX

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

Sponsor	Phase
Telix International Pty Ltd	Phase 3
Grand Pharmaceutical (China) Co., Ltd.	Phase 3
BAMF Health	Early Phase 1

See all ILLUCCIX clinical trials

US Patents and Regulatory Information for ILLUCCIX

ILLUCCIX is protected by one US patents.

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
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032-001	Dec 17, 2021		RX	Yes	Yes

International Patents for ILLUCCIX

When does loss-of-exclusivity occur for ILLUCCIX?

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

Australia

Belgium

Brazil

Canada

China

Denmark

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

South Africa

Spain

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 ILLUCCIX around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2856030
European Patent Office	3185912
Poland	3185911
Canada	2958471
Australia	2015309187

Market Dynamics and Financial Trajectory for Illuccix: An Industry Insight

Last updated: July 27, 2025

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Introduction

Illuccix (formerly known as Lutenium), developed by Lantheus Holdings, Inc., represents a significant advancement in the domain of prostate cancer diagnostics. As a highly targeted, FDA-approved prostate-specific membrane antigen (PSMA) imaging agent, Illuccix elevates the precision and efficacy of prostate cancer detection through PET imaging technology. This report provides a comprehensive analysis of the current market dynamics influencing Illuccix’s growth trajectory and projects its financial outlook amidst evolving industry trends.

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Market Overview

Rise in Prostate Cancer Incidence

Prostate cancer remains among the most diagnosed malignancies globally. According to the World Health Organization, it accounts for approximately 1.3 million new cases annually, making early and precise detection paramount (WHO, 2022). The increasing prevalence has stimulated demand for advanced diagnostic tools, positioning PSMA PET imaging as a pivotal modality.

Pioneering Role of PSMA PET Imaging

Traditional prostate cancer imaging relied on techniques such as bone scans and CT, which often lack sensitivity, especially for metastases. PSMA PET imaging offers higher sensitivity and specificity, enabling clinicians to detect both primary and metastatic disease at earlier stages. Illuccix, as an FDA-approved agent, has gained traction owing to its targeted mechanism and superior diagnostic accuracy, fostering its adoption globally.

Regulatory Milestones and Reimbursement Landscape

The FDA approved Illuccix in December 2021, marking an essential milestone, and paved the way for broader clinical acceptance in the United States. Conversely, in Europe, approval by the European Medicines Agency (EMA) further expands its market access. Reimbursement policies significantly influence market penetration; insurers increasingly recognize the value of PSMA PET scans in reducing unnecessary biopsies and treatments, bolstering utilization.

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Market Drivers Influencing Illuccix

Clinical Evidence Supporting Efficacy

Multiple clinical studies underscore PSMA PET's superior detection capabilities (Fanti et al., 2018). These studies influence clinician adoption, demonstrated through increased referrals. As Illuccix's clinical utility becomes more established, prescriber confidence is expected to grow, translating into revenue increases.

Technological Advancements and Manufacturing Capacity

Lantheus and partnering radiopharmacies continue to refine production processes, reducing costs and expanding inventory. Technological innovations in PET imaging hardware further complement drug adoption, enhancing image resolution and diagnostic confidence.

Patient-centric Healthcare Shift

Increased emphasis on personalized medicine fosters demand for precise diagnostics like Illuccix. Patients now prefer minimally invasive, accurate staging procedures that guide targeted therapy, positioning Illuccix favorably within comprehensive prostate cancer management.

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Market Challenges and Competitive Landscape

Competition from Alternative Imaging Agents

While Illuccix leads in the US, other radiotracers such as Pylarify (piflufolastat) by Fusion Pharmaceuticals and Novartis's Ga-68 based agents protonate market competition. Differentiators include regulatory timing, proprietary production pipelines, and reimbursement policies.

Supply Chain and Production Limitations

The short half-life of the radiotracer (~6 hours) necessitates sophisticated supply chain logistics. Disruptions or bottlenecks in production capacity could hamper availability, impacting sales trajectories.

Regulatory and Reimbursement Uncertainties

While initial approvals are secured, ongoing coverage decisions require persistent engagement with regulators and payers. Changes in healthcare policies or reduced reimbursement rates can limit market growth.

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Financial Trajectory and Revenue Projections

Current Revenue Streams

Lantheus reports preliminary revenue contributions from Illuccix, reflecting uptake within early adopter centers. With initial FDA approval only in late 2021, sales growth remains in early phases.

Forecasted Growth Trajectory

Industry analysts project that the global PSMA PET imaging market will surpass USD 2 billion by 2027, growing at a CAGR of approximately 15%. Given Illuccix’s relatively recent market entry, a conservative estimate anticipates annual growth rates of 20-25%, driven by expanding indications and geographic penetration (Market Research Future, 2022).

Market Expansion Opportunities

• Geographic Penetration: Beyond the US, Europe and Asia-Pacific constitute substantial growth zones, contingent on regulatory approvals and establishment of local supply chains.

• Clinical Adoption: Increased clinical trial data supports expanded indications, such as recurrent prostate cancer assessment, enlarging its addressable market.

• Partnerships and Collaborations: Strategic alliances with nuclear medicine providers enhance distribution and familiarity among healthcare providers.

Revenue Outlook (2023-2027)

• 2023: USD 150 million – driven by initial uptake and regional launches.

• 2024-2025: USD 250-350 million – as adoption accelerates, reimbursement policies solidify, and awareness increases.

• 2026-2027: USD 500 million+ – reaching broader markets and new indications, with emerging competitors regulated accordingly.

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Strategic Implications for Stakeholders

For Investors and Business Leaders

The evolving landscape indicates substantial growth potential, but firms must navigate supply chain complexities, regulatory hurdles, and competitive threats. Investing in technological innovation, expanding geographic reach, and establishing payer collaborations will be critical drivers of long-term profitability.

For Healthcare Providers

Rapid adoption hinges on clinical evidence, surgeon and radiologist familiarity, and reimbursement clarity. Emphasizing training and demonstrating clinical utility will reinforce Illuccix’s standing.

For Policy Makers

Supportive policies facilitating rapid approval, reimbursement, and infrastructure development will catalyze industry growth, ensuring that benefits of advanced PSMA PET imaging reach broader patient populations.

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Key Takeaways

• Growing Demand: The rising incidence of prostate cancer coupled with the superior diagnostic capabilities of PSMA PET imaging underscores a robust growth trajectory for Illuccix.

• Market Expansion: Strategic entry into international markets, coupled with expanding clinical indications, positions Illuccix for substantial revenue growth—potentially surpassing USD 500 million annually by 2027.

• Competitive Landscape: While Illuccix benefits from early FDA approval, competition from other radiotracers and logistical challenges necessitate continuous innovation and strategic partnerships.

• Regulatory and Reimbursement Dynamics: Achieving regulatory approvals internationally and securing favorable reimbursement are crucial for sustained growth.

• Industry Trends: Advancements in PET imaging tech and personalized healthcare paradigms align favorably with Illuccix’s clinical utility, reinforcing its market position.

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FAQs

1. What differentiates Illuccix from other PSMA radiotracers?
   Illuccix is a fluorine-18-based radiotracer offering longer half-life (~110 minutes), simplifying logistics and distribution compared to gallium-68 tracers. Additionally, its specific clinical data and regulatory approvals reinforce its prominence.

2. What are the primary barriers to Illuccix’s market growth?
   Key barriers include supply chain limitations due to radiotracer half-life, competition from alternative agents, inconsistent reimbursement policies, and regulatory approvals in key markets.

3. How does reimbursement impact Illuccix’s adoption?
   Favorable reimbursement significantly influences clinical adoption. Evidence demonstrating cost-effectiveness and comprehensive payer coverage accelerates uptake by healthcare providers.

4. What is the projected timeline for Illuccix’s international expansion?
   Pending regulatory approvals in Europe, Asia, and other jurisdictions, international expansion is expected within the next 2-3 years, contingent on local evaluation processes.

5. How does Illuccix fit into overall prostate cancer management?
   Illuccix enhances disease staging precision, influencing treatment decisions such as surgery, radiation, or systemic therapies, thereby integrating into multidisciplinary care pathways.

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Conclusion

Illuccix is poised to become a cornerstone product in the rapidly expanding PSMA PET imaging market. Its robust clinical utility, regulatory foothold, and strategic expansion prospects underpin a promising financial trajectory. Stakeholders must remain attuned to regulatory developments, technological innovations, and market dynamics to capitalize on the significant growth opportunities presented by this targeted diagnostic agent.

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Sources

[1] World Health Organization (2022). Global Cancer Statistics.
[2] Fanti, S., et al. (2018). "Use of 68Ga-PSMA PET/CT in prostate cancer patients." European Journal of Nuclear Medicine and Molecular Imaging.
[3] Market Research Future (2022). "Global PSMA PET Imaging Market Report."