You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

~ Buy the ILLUCCIX (gallium ga-68 gozetotide) Drug Profile, 2024 PDF Report in the Report Store ~

ILLUCCIX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-two 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

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ILLUCCIX?
  • What are the global sales for ILLUCCIX?
  • What is Average Wholesale Price for ILLUCCIX?
Summary for ILLUCCIX
International Patents:42
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
Drug patent expirations by year for ILLUCCIX
Drug Prices for ILLUCCIX

See drug prices for ILLUCCIX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ILLUCCIX
Generic Entry Date for ILLUCCIX*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Telix International Pty LtdPhase 3
Grand Pharmaceutical (China) Co., Ltd.Phase 3
Telix International Pty LtdEarly Phase 1

See all ILLUCCIX clinical trials

US Patents and Regulatory Information for ILLUCCIX

ILLUCCIX is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ILLUCCIX is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe ⤷  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 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

Patent: 15309187
Patent: Kit for radiolabelling with 68GA comprising a metal inhibitor
Estimated Expiration: ⤷  Subscribe

Patent: 15309188
Patent: Mono-, di- or polysaccharide used as metal inhibitor in the preparation of 68Ga-chelate-functionalized targeting agent
Estimated Expiration: ⤷  Subscribe

Patent: 20220193
Patent: Kit for radiolabelling with 68GA comprising a metal inhibitor
Estimated Expiration: ⤷  Subscribe

Patent: 20220194
Patent: Mono-,di- or polysaccharide used as metal inhibitor in the preparation of 68Ga-chelate-functionalized targeting agent
Estimated Expiration: ⤷  Subscribe

Patent: 22202346
Patent: Kit for radiolabelling with 68GA comprising a metal inhibitor
Estimated Expiration: ⤷  Subscribe

Patent: 22202439
Patent: Mono-,di- or polysaccharide used as metal inhibitor in the preparation of 68Ga-chelate-functionalized targeting agent
Estimated Expiration: ⤷  Subscribe

Belgium

Patent: 21191
Patent: KIT POUR RADIOMARQUAGE.
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2017003578
Patent: kit para radiomarcação com 68ga compreendendo um inibidor de metal
Estimated Expiration: ⤷  Subscribe

Patent: 2017003710
Patent: mono-, di- ou polissacarídeo usado como inibidor de metal na preparação de agente de direcionamento com grupamento funcional de 68ga-quelato
Estimated Expiration: ⤷  Subscribe

Patent: 2021017474
Patent: Método para radiomarcação de um agente de direcionamento com grupamento funcional de quelato com um radionuclídeo de metal, e kit para radiomarcação
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 58471
Patent: KIT POUR LE RADIOMARQUAGE AU 68GA COMPRENANT UN INHIBITEUR METALLIQUE (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR)
Estimated Expiration: ⤷  Subscribe

Patent: 58475
Patent: MONO-, DI- OU OLIGOSIDE UTILISE COMME INHIBITEURS METALLIQUES DANS LA PREPARATION D'AGENTS CIBLES FONCTIONNALISES METAL-CHELATE (MONO-, DI- OR OLIGOSACCHARIDE USED AS METAL INHIBITORS IN THE PREPARATION OF RADIOACTIVE METAL-CHELATE-FUNCTIONALIZED TARGET AGENTS)
Estimated Expiration: ⤷  Subscribe

Patent: 67294
Patent: MONO-, DI- OU POLYSACCHARIDE UTILISE COMME INHIBITEUR METALLIQUE DANS LAPREPARATION D'AGENTS CIBLES FONCTIONNALISES DU CHELATE 68GA (MONO-, DI- OR POLYSACCHARIDE USED AS METAL INHIBITOR IN THE PREPARATION OF 68GA-CHELATE-FUNCTIONALIZED TARGETING AGENT)
Estimated Expiration: ⤷  Subscribe

China

Patent: 6659806
Patent: 在制备68GA‑螯合物官能化的靶向剂中用作金属抑制剂的单糖、二糖或多糖 (Mono-, di- or polysaccharide used as metal inhibitor in the preparation of 68GA-chelate-functionalized targeting agent)
Estimated Expiration: ⤷  Subscribe

Patent: 6794265
Patent: 用于使用68GA放射性标记的含金属抑制剂的试剂盒 (Kit for radiolabelling with 68ga comprising a metal inhibitor)
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 85911
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 85911
Patent: KIT POUR LE RADIOMARQUAGE AU 68GA COMPRENANT UN INHIBITEUR MÉTALLIQUE (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR)
Estimated Expiration: ⤷  Subscribe

Patent: 85912
Patent: MONOSACCHARIDE, DISACCHARIDE OU POLYSACCHARIDE UTILISÉ COMME INHIBITEUR DE MÉTAL DANS LA PRÉPARATION DE D'AGENT DE CIBLAGE FONCTIONNALISÉ PAR DU 68GA-CHÉLATE (MONO-, DI- OR POLYSACCHARIDE USED AS METAL INHIBITOR IN THE PREPARATION OF 68GA-CHELATE-FUNCTIONALIZED TARGETING AGENT)
Estimated Expiration: ⤷  Subscribe

Patent: 62025
Patent: KIT POUR LE RADIOMARQUAGE AU 68GA COMPRENANT UN INHIBITEUR MÉTALLIQUE (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR)
Estimated Expiration: ⤷  Subscribe

Patent: 62026
Patent: MONOSACCHARIDE, DISACCHARIDE OU POLYSACCHARIDE UTILISÉ COMME INHIBITEUR DE MÉTAL DANS LA PRÉPARATION DE D'AGENT DE CIBLAGE FONCTIONNALISÉ PAR DU 68GA-CHÉLATE (MONO-, DI- OR POLYSACCHARIDE USED AS METAL INHIBITOR IN THE PREPARATION OF 68GA-CHELATE-FUNCTIONALIZED TARGETING AGENT)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 53971
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 0735
Patent: חד-, דו- או פוליסכאריד המשמש כמעכב מתכת בהכנה של ga68-קלאט-גורם ממקד משופעל (Mono-, di- or polysaccharide used as metal inhibitor in the preparation of 68ga-chelate-functionalized targeting agent)
Estimated Expiration: ⤷  Subscribe

Patent: 0736
Patent: ערכה עבור התוויה רדיואקטיבית עם ga68 המכיל מעכב מתכת (Kit for radiolabelling with 68ga comprising a metal inhibitor)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 43343
Estimated Expiration: ⤷  Subscribe

Patent: 52622
Estimated Expiration: ⤷  Subscribe

Patent: 17526745
Patent: 金属阻害剤
Estimated Expiration: ⤷  Subscribe

Patent: 17530188
Patent: 放射標識用キット
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 17002361
Patent: MONO-, DI-, O POLISACARIDO USADO COMO INHIBIDOR DE METAL EN LA PREPARACION DEL AGENTE ENFOCADO FUNCIONALIZADO CON QUELATO GALIO 68 (68GA). (MONO-, DI- OR POLYSACCHARIDE USED AS METAL INHIBITOR IN THE PREPARATION OF 68GA-CHELATE-FUNCTIONALIZED TARGETING AGENT.)
Estimated Expiration: ⤷  Subscribe

Patent: 17002362
Patent: KIT PARA MARCAJE RADIACTIVO CON GALIO 68 (68GA) QUE COMPRENDE UN INHIBIDOR DE METAL. (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR.)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 9291
Patent: Kit for radiolabelling with 68ga comprising a metal inhibitor
Estimated Expiration: ⤷  Subscribe

Patent: 9293
Patent: Mono-, di- or polysaccharide used as metal inhibitor in the preparation of 68ga-chelate-functionalized targeting agent
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 85911
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 85911
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 24894
Patent: НАБОР ДЛЯ МЕЧЕНИЯ РАДИОАКТИВНЫМИ ИЗОТОПАМИ (RADIO-ISOTOPE LABELING KIT)
Estimated Expiration: ⤷  Subscribe

Patent: 25627
Patent: ИНГИБИТОР МЕТАЛЛОВ (METAL INHIBITOR)
Estimated Expiration: ⤷  Subscribe

Patent: 17109582
Patent: ИНГИБИТОР МЕТАЛЛОВ
Estimated Expiration: ⤷  Subscribe

Patent: 17109583
Patent: НАБОР ДЛЯ МЕЧЕНИЯ РАДИОАКТИВНЫМИ ИЗОТОПАМИ
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1702152
Patent: KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 55991
Estimated Expiration: ⤷  Subscribe

Patent: 56030
Estimated Expiration: ⤷  Subscribe

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
Canada 2958471 KIT POUR LE RADIOMARQUAGE AU 68GA COMPRENANT UN INHIBITEUR METALLIQUE (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR) ⤷  Subscribe
Brazil 122021017474 Método para radiomarcação de um agente de direcionamento com grupamento funcional de quelato com um radionuclídeo de metal, e kit para radiomarcação ⤷  Subscribe
Brazil 112017003710 mono-, di- ou polissacarídeo usado como inibidor de metal na preparação de agente de direcionamento com grupamento funcional de 68ga-quelato ⤷  Subscribe
New Zealand 729291 Kit for radiolabelling with 68ga comprising a metal inhibitor ⤷  Subscribe
Spain 2855991 ⤷  Subscribe
Portugal 3185911 ⤷  Subscribe
Australia 2020220193 Kit for radiolabelling with 68GA comprising a metal inhibitor ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

ILLUCCIX Market Analysis and Financial Projection Experimental

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.