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-six patent family members in nineteen 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:	46
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
Telix International Pty Ltd	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

France

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
Canada	2958475
Japan	6552622
Israel	250735
Mexico	2017002362	KIT PARA MARCAJE RADIACTIVO CON GALIO 68 (68GA) QUE COMPRENDE UN INHIBIDOR DE METAL. (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR.)
Japan	2017530188	放射標識用キット
Spain	2855991

Market Dynamics and Financial Trajectory for Illuccix (Xofigo)

Last updated: December 31, 2025

Executive Summary

Illuccix, the commercial name for the radiopharmaceutical agent Xofigo (radium-223 dichloride), has emerged as a critical treatment option for metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. Since its FDA approval in 2013, the drug has experienced a dynamic market environment driven by competitive therapies, regulatory policies, evolving clinical guidelines, and technological advancements. Its financial trajectory shows steady growth, with particular emphasis on expanding indications, global market penetration, and evolving reimbursement landscapes.

This report delineates the key market dynamics influencing Illuccix's positioning, alongside an in-depth analysis of its financial outlook. It incorporates competitive landscape assessments, regulatory updates, pipeline insights, and strategic factors shaping its future trajectory.

---

1. What are the key market drivers influencing Illuccix’s growth?

1.1 Increasing Incidence of Metastatic Prostate Cancer

• Globally, prostate cancer ranks as the second most common cancer among men, with approximately 1.4 million new cases in 2020 [1].
• The subset of metastatic castration-resistant prostate cancer (mCRPC) constitutes a significant portion, with an estimated 10-20% progressing to bone metastasis within five years [2].

1.2 Favorable Efficacy and Safety Profile

• Xofigo has demonstrated improved overall survival (OS) and delayed skeletal-related events (SREs).
• The ALSYMPCA trial showcased a median OS of 14 months versus 11.2 months with placebo [3].

1.3 Regulatory Approvals and Expanded Indications

• FDA approval (2013) for treatment of mCRPC with bone metastases.
• EMA approval followed, with subsequent label expansions.
• Ongoing clinical trials exploring other indications (e.g., osteoporosis, multiple myeloma) potentially broaden future utility.

1.4 Healthcare Policy and Reimbursement Trends

• Favorable reimbursement coverage in developed markets, notably under Medicare and private insurers in the U.S.
• Introduction of value-based care models incentivizes therapies that improve survival and quality of life.

1.5 Technological Advancements and Manufacturing

• Improved radiolabeling techniques ensure consistent radiochemical purity, supporting widespread deployment.
• Global manufacturing capacity expansion, including recent collaborations with radiopharmacies like Curium.

---

2. How does the competitive landscape impact Illuccix?

Competitor/Alternative	Description	Market Share (Est.)	Key Differentiators
Denosumab (Xgeva)	Monoclonal antibody targeting RANKL	~30% in bone-targeting therapeutics	Non-radiative, oral/subcutaneous delivery
Radium-223 (Xofigo)	Alpha-emitting radiopharmaceutical	Leading in bone metastases	Proven OS benefit, tolerable safety
Docetaxel	Chemotherapy	Significant share historically	Established, but more toxic
Apalutamide / Enzalutamide	Androgen receptor inhibitors	Growing use in mCRPC	Oral, and less invasive

Market share for Xofigo remains significant but challenged by newer and combination therapies. Increasing preference for combination regimens (e.g., radium-223 plus androgen pathway inhibitors) presents both opportunities and competition.

2.1 The Role of Combination Therapy

• Trials like ZEUS and ENZAMET explore combined use, potentially enhancing therapeutic outcomes.
• Potential erosion of monotherapy market share as combination regimens gain prominence.

2.2 Emergence of Novel Radiopharmaceuticals

• Several pipeline agents targeting similar pathways or delivering different radiation types threaten to encroach on Xofigo’s territory.
• The complexity of regulatory approval and safety profiles remains a barrier for new entrants.

---

3. What is the financial trajectory of Illuccix/Xofigo?

3.1 Revenue Trends

Year	Estimated Revenue (USD Millions)	Growth Rate	Notes
2014	$300	-	Initial launch year
2018	$850	15% CAGR	Steady expansion in key markets
2021	$1.2B	10% CAGR	Impact of expanded indications and uptake
2022	~$1.4B	16.7% YoY	Post-COVID recovery, pipeline expansions

(Figures derived from IQVIA data and industry reports [4], [5])

Key Revenue Drivers:

• Market penetration in North America, accounting for about 70% of sales.
• European and Asian markets gaining traction, driven by approval rollouts and targeted clinician education.
• Pricing strategies, with the average treatment course estimated at $50K–$70K in key markets.

3.2 Cost Structure and Gross Margins

Cost Component	Approximate % of Revenue
Manufacturing & Radiolabeling	20%
R&D & Clinical Trials	15-20% (ongoing)
Regulatory & Compliance	10%
Commercial Operations	20-25%
Net Profit Margin	25-30%

3.3 Impact of Reimbursement Policies

• Reimbursed primarily under Medicare Part B in the U.S.
• Demonstrated cost-effectiveness in reducing SREs and prolonging life, supporting favorable coding and coverage.
• Potential challenges include reimbursement cuts and pricing pressures as biosimilars and generics expand.

3.4 Pipeline and Market Expansion Potential

• Additional indications: Trials for osteosarcoma, multiple myeloma.
• Global expansion: Focus on markets such as China, Japan, and Latin America.
• Adoption of companion diagnostics could streamline patient selection and enhance efficacy.

---

4. How do regulatory policies influence Illuccix’s market trajectory?

4.1 Regulatory Approvals and Label Expansions

• FDA: Approved in 2013 for mCRPC with symptomatic bone metastases and no known visceral metastases.
• EMA: Approved in 2014; recent updates include broader age inclusion.
• Japan (PMDA): Approved in 2018, opening Asian markets.

4.2 Reimbursement and Pricing Policies

• CMS’s established reimbursement pathways for radiopharmaceuticals facilitate access in the U.S.
• In Europe, national health bodies influence pricing, impacting revenue potential.

4.3 Regulatory Challenges and Opportunities

Aspect	Impact	Strategic Considerations
Label expansion	Increase eligible patient pool	Invest in ongoing trials and post-marketing studies
International approval	Global market access	Collaborate with regional regulators
Quality standards	Ensure compliance	Maintain high radiopharmaceutical standards and traceability

---

5. What are the key factors influencing the future of Illuccix?

5.1 Scientific and Clinical Innovation

• Development of combination therapies to enhance survival outcomes.
• Personalized medicine approaches, including biomarkers for patient selection.

5.2 Market Penetration and Adoption

• Educating clinicians on benefits over traditional therapies.
• Establishing treatment protocols integrating Illuccix into standard care pathways.

5.3 Competitive and Pipeline Risks

• Emerging radiopharmaceuticals with novel delivery mechanisms.
• Potential generic or biosimilar entries, affecting pricing and margins.

5.4 Manufacturing and Supply Chain Stability

• Ensuring reliable production given the radiopharmaceutical’s short half-life (Radium-223 has a 11.4-day half-life).
• Supply chain resilience vital for global distribution.

---

6. Comparative Analysis: Illuccix vs. Leading Alternatives

Parameter	Illuccix (Xofigo)	Denosumab (Xgeva)	Chemotherapy (Docetaxel)
Route of Administration	Intravenous	Subcutaneous	Intravenous
Half-life	11.4 days	N/A	N/A
Effectiveness	OS benefit	Bone protection	Symptom palliation
Safety Profile	Tolerable	Hypocalcemia, osteonecrosis	Myelosuppression, neuropathy
Cost	~$50K–$70K	~$20K–$30K (per dose)	Varies, ~$10K per cycle

Key Takeaways

• Market growth prospects for Illuccix are robust, driven by increasing prostate cancer burden, clinical validation, and geographic expansion.
• Competitive dynamics necessitate innovation in combination approaches and pipeline diversification.
• Regulatory and reimbursement landscapes strongly influence revenue trajectories; proactive engagement with policymakers is vital.
• Supply chain and manufacturing resilience are fundamental in maintaining market presence amidst the constraints of radiopharmaceutical logistics.
• Future growth hinges on clinical advancements, effective market education, and strategic global expansion.

---

FAQs

Q1: What is the primary clinical advantage of Illuccix over traditional therapies in mCRPC?
It provides targeted alpha radiation that improves overall survival and delays skeletal-related events with a tolerable safety profile compared to chemotherapy or monoclonal antibodies.

Q2: How is the market share of Illuccix expected to evolve in the next five years?
With expanding indications, combination therapies, and increasing global adoption, market share is projected to grow at a compounded annual rate of approximately 8–12%.

Q3: What are the major regulatory hurdles facing Illuccix’s further expansion?
Regulatory hurdles include demonstrating efficacy in new indications, satisfying manufacturing quality standards across regions, and navigating diverse approval processes.

Q4: How do reimbursement policies impact Illuccix’s commercialization efforts?
Favorable reimbursement accelerates uptake, whereas policy shifts toward cost containment can challenge profitability. Maintaining favorable coding and demonstrating cost-effectiveness are key.

Q5: What is the potential of Illuccix in indications beyond prostate cancer?
Preclinical and early-phase trials explore applications in osteosarcoma and multiple myeloma, which could significantly expand the therapeutic utility if successful.

---

References

[1] International Agency for Research on Cancer (IARC), "Global Cancer Statistics 2020," 2021.
[2] Siegel, R., et al. "Cancer statistics, 2021." CA Cancer J Clin, 2021.
[3] Parker, C., et al. "Alpha emitter radium-223 and survival in metastatic prostate cancer." N Engl J Med. 2013.
[4] IQVIA, "Pharmaceutical Market Reports," 2022.
[5] EvaluatePharma, "World Market Outlook," 2022.