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-three 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. Four 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.

Indicators of Generic Entry

Summary for ILLUCCIX

International Patents:	43
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

11,027,031

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.

This potential generic entry date is based on patent 11,027,031.

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	11,027,031

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
Australia	2022202439
Australia	2015309187
China	106659806
Hungary	E053971
Israel	250735
World Intellectual Property Organization (WIPO)	2016030104

Market Dynamics and Financial Trajectory for Illuccix

Introduction to Illuccix

Illuccix, a prostate cancer imaging agent developed by Telix Pharmaceuticals, has been a pivotal product in the company's growth and financial success. Here, we delve into the market dynamics and financial trajectory of Illuccix, highlighting its impact on Telix Pharmaceuticals and the broader healthcare industry.

Market Adoption and Growth

U.S. Market Performance

Illuccix has seen significant growth in the U.S. market, particularly in its second full year of commercial sales. The drug has experienced a 218% increase in revenue compared to 2022, with U.S. sales being the primary driver of this growth. In the first half of 2024, revenue from Illuccix in the U.S. continued to rise, contributing to a total group revenue of $364.0 million, a 65% increase from the first half of 2023[2][5].

Global Expansion

Telix is actively expanding Illuccix into new geographies. The drug has been commercially launched in Canada, and marketing authorization applications have been submitted in the European Union and the United Kingdom. Additionally, regulatory submissions are in progress in other jurisdictions, such as Brazil, where approval is anticipated in Q3 2024[1][4][5].

Regulatory Milestones

Expanded Indications

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Illuccix, expanding its label to include patient selection for prostate-specific membrane antigen (PSMA)-directed radioligand therapy. This expanded indication has further enhanced the drug's clinical differentiation and market appeal[4].

International Approvals

Illuccix has received regulatory approvals in multiple countries, including Canada, where it is the first and only PSMA-PET imaging agent approved. The company is also progressing with marketing authorizations in the UK and EU, with submissions already made to the relevant regulatory agencies[1][4].

Financial Performance

Revenue Growth

The financial performance of Illuccix has been robust. In 2023, Telix reported a revenue of $502.5 million, a 214% increase from the previous year, primarily driven by Illuccix sales. For the first half of 2024, the company reported a total revenue of $364.0 million, with Illuccix sales in the U.S. contributing significantly to this figure[1][2].

Profitability

Telix has transitioned from a net loss of $104.1 million in 2022 to a net profit of $5.2 million in 2023, largely due to the success of Illuccix. In the first half of 2024, the company reported a net profit after tax of $29.7 million, compared to a net loss of $14.3 million in the same period of 2023[1][2].

Gross Margin Improvement

The gross margin for Illuccix has steadily improved, reaching 66% in the first half of 2024, up from 63% in the first half of 2023. This improvement is attributed to optimized manufacturing and distribution costs, as well as stable selling prices[2][5].

Operational Highlights

Supply Chain and Manufacturing

Telix has enhanced its supply chain and manufacturing capabilities through the acquisition of ARTMS and IsoTherapeutics. These acquisitions have provided greater control over the supply chain and increased self-sufficiency in manufacturing key isotopes such as gallium-68 (68 Ga) and zirconium-89 (89 Zr), which are crucial for Illuccix and other products[5].

Cash Flow and Financing

The company has generated significant cash from operating activities, with $39.1 million in the first half of 2024, primarily from Illuccix sales. Additionally, Telix completed a convertible bond financing, raising $650.0 million, which will support future growth and strategic initiatives[2][5].

Strategic Focus

Expanding Commercial Footprint

Telix is focused on broadening its commercial footprint in urology by expanding Illuccix into new indications and obtaining approvals for synergistic products. The company is also developing AI solutions and other diagnostic tools to support healthcare practitioners across the patient journey[1].

Pipeline Development

The success of Illuccix has enabled Telix to invest in its therapeutic pipeline. Positive efficacy data from the ProstACT SELECT trial and the CUPID study have reinforced the clinical potential of TLX591, a Phase III asset for prostate cancer therapy. The company is also progressing with other significant clinical milestones across its therapeutic pipeline[2][5].

Market Differentiation

Clinical Differentiation

Illuccix's clinical differentiation, particularly its expanded label for patient selection for PSMA-directed radioligand therapy, has been a key factor in its market success. This differentiation has helped Telix to increase market share and minimize the impact of new entrants in the market[3].

Service and Delivery

Telix's focus on service and reliable delivery of doses has been crucial in winning and retaining customers. The company's scheduling flexibility and clinical support have enhanced its market position and customer engagement[4].

Future Prospects

Revenue Guidance

Telix has reaffirmed its full-year 2024 revenue guidance of US$490M to US$510M, representing a 48-54% increase over 2023. This guidance is based on the continued growth of Illuccix sales and the expected launch of new products in 2025, subject to regulatory approval[2][3][5].

New Product Launches

The company plans to launch three new products in 2025, which will further expand its precision medicine diagnostics portfolio. These launches are expected to contribute to the company's future revenue and growth[2].

Key Takeaways

• Revenue Growth: Illuccix has driven significant revenue growth for Telix, with a 218% increase in 2023 and continued strong performance in 2024.
• Global Expansion: The drug is being expanded into new geographies, including Canada, the EU, and the UK.
• Regulatory Milestones: Expanded indications and international approvals have enhanced the drug's market appeal.
• Financial Performance: Transition from net loss to net profit, with improved gross margins and strong cash flow.
• Operational Strengths: Enhanced supply chain and manufacturing capabilities, and significant financing to support future growth.
• Strategic Focus: Expanding commercial footprint in urology and investing in therapeutic pipeline.

FAQs

Q: What is Illuccix, and how has it impacted Telix Pharmaceuticals?

Illuccix is a prostate cancer imaging agent that has been a major driver of revenue and growth for Telix Pharmaceuticals, contributing to the company's transition from a net loss to a net profit.

Q: What are the key regulatory milestones for Illuccix?

Illuccix has received FDA approval for an expanded label to include patient selection for PSMA-directed radioligand therapy and has been approved in Canada. Marketing authorization applications are in progress in the EU and UK.

Q: How has the global expansion of Illuccix affected Telix's revenue?

The global expansion of Illuccix has significantly contributed to Telix's revenue growth, with the drug being launched in Canada and regulatory submissions in progress in other jurisdictions.

Q: What are the future prospects for Illuccix and Telix Pharmaceuticals?

Telix has reaffirmed its revenue guidance for 2024 and plans to launch new products in 2025, which are expected to further drive revenue and growth.

Q: How has Telix managed its supply chain and manufacturing for Illuccix?

Telix has enhanced its supply chain and manufacturing capabilities through the acquisition of ARTMS and IsoTherapeutics, providing greater control and self-sufficiency in key isotope production.

Sources

1. Telix Pharmaceuticals 2023 Annual Report: "Our performance, strategy and future prospects" - https://annualreport.telixpharma.com/2023/operating-and-financial-review/our-performance-strategy-and-future-prospects
2. Telix 2024 Half-Year Results: "Strong Commercial Revenue and Profit Growth to Support Strategic Priorities" - https://telixpharma.com/news-views/telix-2024-half-year-results-strong-commercial-revenue-and-profit-growth-to-support-strategic-priorities/
3. Telix Pharmaceuticals Q2 2024 Revenue and Business Highlights: "Guidance Upgrade" - https://www.prnewswire.com/apac/news-releases/telix-pharmaceuticals-q2-2024-revenue-and-business-highlights-guidance-upgrade-302199928.html
4. Telix Reports Q1 2023 Financial Results: "Delivers First $100M Revenue Quarter" - https://www.prnewswire.com/apac/news-releases/telix-reports-q1-2023-financial-results-delivers-first-100m-revenue-quarter-301798738.html
5. Telix 2024 Half-Year Results: "Strong Commercial Revenue and Profit Growth to Support Strategic Priorities" - https://www.globenewswire.com/news-release/2024/08/22/2934023/0/en/Telix-2024-Half-Year-Results-Strong-Commercial-Revenue-and-Profit-Growth-to-Support-Strategic-Priorities.html