XOFIGO Drug Patent Profile

Which patents cover Xofigo, and what generic alternatives are available?

Xofigo is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in XOFIGO is radium ra-223 dichloride. One supplier is listed for this compound. Additional details are available on the radium ra-223 dichloride profile page.

Summary for XOFIGO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	30
Drug Prices:	Drug price information for XOFIGO
What excipients (inactive ingredients) are in XOFIGO?	XOFIGO excipients list
DailyMed Link:	XOFIGO at DailyMed

See drug prices for XOFIGO

Recent Clinical Trials for XOFIGO

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

Sponsor	Phase
GenesisCare USA	Phase 3
Bayer	Phase 4
MANA RBM	Phase 3

See all XOFIGO clinical trials

Pharmacology for XOFIGO

Drug Class	Radioactive alpha-Particle Emitting Therapeutic Agent
Mechanism of Action	alpha-Particle Emitting Activity

US Patents and Regulatory Information for XOFIGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971-001	May 15, 2013		RX	Yes	Yes

Expired US Patents for XOFIGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971-001	May 15, 2013

International Patents for XOFIGO

See the table below for patents covering XOFIGO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1140212
Eurasian Patent Organization	200100642
Japan	5433490
Germany	69932183
Mexico	PA01006823	PREPARACION Y USO DE RADIO-223 PARA MARCAR TEJIDOS CALCIFICADOS PARA EL ALIVIO DEL DOLOR, TERAPIA PARA EL CANCER DE HUESOS, Y ACONDICIONAMIENTO DE LA SUPERFICIE DE LOS HUESOS. (THE PREPARATION AND USE OF RADIUM-223 TO TARGET CALCIFIED TISSUES FOR PAIN PALLIATION, BONE CANCER THERAPY, AND BONE SURFACE CONDITIONING.)

Supplementary Protection Certificates for XOFIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140212	507	Finland
1140212	33/2014	Austria		PRODUCT NAME: RADIUM-223-DICHLORID; REGISTRATION NO/DATE: EU/1/13/873 20131113
1140212	C300666	Netherlands		PRODUCT NAME: RADIUM-223, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/13/873/001 20131113
1140212	2014/033	Ireland		PRODUCT NAME: RADIUM-223 AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/873 20131113
1140212	C01140212/01	Switzerland		PRODUCT NAME: RADIUM RA-223; REGISTRATION NO/DATE: SWISSMEDIC 62732 29.08.2014

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XOFIGO

Last updated: August 1, 2025

Introduction

XOFIGO (radium Ra 223 dichloride) is a targeted alpha particle radiotherapy developed by Bayer Pharmaceuticals, primarily approved for the treatment of metastasized castration-resistant prostate cancer (mCRPC) with symptomatic bone metastases. Since its FDA approval in 2013, XOFIGO has experienced significant market growth, driven by evolving treatment paradigms, increasing patient populations, and strategic positioning within oncology therapeutics. This report analyzes the current market dynamics and financial trajectory of XOFIGO, highlighting key trends, competitive forces, and growth prospects.

Market Overview

The global prostate cancer therapeutics market has seen sustained expansion driven by rising incidence rates, aging populations, and advances in targeted treatment options. Prostate cancer remains the second most common cancer among men worldwide, with an estimated 1.4 million new cases in 2020 alone [1]. Advanced prostate cancer, notably mCRPC, accounts for a substantial share of oncology treatment expenditures due to its complex management and limited therapeutic options.

XOFIGO addresses a niche—patients with bone-dominant mCRPC who have progressed after androgen deprivation therapy (ADT). Its unique mechanism—delivering high-energy alpha particles to selectively target bone metastases—sets it apart from traditional chemotherapeutic agents and hormonal therapies. As the first radiopharmaceutical specifically approved for prostate cancer, XOFIGO’s market penetration has been significant but remains influenced by evolving competition and treatment guidelines.

Market Drivers

1. Increasing Incidence of Prostate Cancer

Aging demographics and improved diagnostic capabilities lead to increased detection of prostate cancer, especially in advanced stages. According to the International Agency for Research on Cancer (IARC), prostate cancer incidence is projected to rise globally, with more patients eligible for XOFIGO treatment [2].

2. Advancement in Treatment Guidelines

National and international guidelines now recommend radiopharmaceuticals like XOFIGO as a standard option for mCRPC with bone metastases. The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) acknowledge XOFIGO’s role, enhancing clinician familiarity and adoption [3].

3. Superior Efficacy and Safety Profile

Clinical trials, notably the ALSYMPCA study, demonstrated significant survival benefits—median overall survival of 14 months versus 11.2 months for placebo—with manageable toxicity profiles. Such data bolster market confidence and facilitate formulary inclusion [4].

4. Increasing Reimbursement and Access

As healthcare systems recognize the clinical benefits, reimbursement coverage in major markets, including the U.S., EU, and Asia, has expanded. This broad access drives higher prescription volumes across diverse healthcare settings.

Market Challenges

1. Competition & Evolving Therapeutic Landscape

Numerous agents—including androgen receptor-targeted therapies (e.g., enzalutamide, abiraterone), chemotherapy (docetaxel), and immunotherapies—compete within the mCRPC space. Emerging radiopharmaceuticals, such as actinium-225-based agents, pose potential threats [5].

2. Limited Indication Expansion

XOFIGO’s approved label is confined to prostate cancer with bone metastases. Attempts to expand indications to other cancers or non-bony metastases face scientific and regulatory hurdles, limiting revenue diversification.

3. Manufacturing & Supply Chain Constraints

Radium-223’s short half-life (~11.4 days) complicates logistics, requiring specialized supply chains. Any disruptions could impact availability and sales consistency.

Financial Trajectory and Revenue Trends

Revenue Performance

Bayer reported initial revenues of approximately €250 million (~$280 million) in 2018, with subsequent growth to roughly €321 million (~$360 million) in 2021. Growth has been sustained through increased adoption in key geographies, especially North America and Europe. The U.S. remains the largest market, driven by established treatment protocols and insurance coverage.

Market Penetration and Pipeline Potential

While the primary revenue driver remains the existing indication, Bayer continues investments in clinical trials exploring combinations with immunotherapies and other systemic agents. Early-phase studies hint at potential indication expansion, which could significantly influence future revenues if successful.

Impact of Competitive Dynamics

The emergence of novel radiopharmaceuticals and combination regimens could threaten XOFIGO’s market share. Bayer’s strategic focus on physician engagement, reimbursement negotiations, and new formulation development aims to sustain sales growth.

Forecasting and Future Outlook

Analysts project a compound annual growth rate (CAGR) of 4-6% for XOFIGO sales over the next five years, assuming stable market conditions and incremental clinical benefits from combination strategies. However, market saturation and saturation of existing indications might temper exponential growth.

Strategic Opportunities

• Indication Expansion: Broader use in earlier stages of prostate cancer or in combination with other systemic therapies could unlock new revenue streams.
• Geographic Expansion: Entering emerging markets with burgeoning healthcare infrastructure offers substantial upside.
• Pipeline Development: Supporting ongoing trials for novel radiopharmaceuticals and exploring broader oncological applications could reshape revenue trajectories.

Conclusion

XOFIGO remains a pivotal therapy within the prostate cancer treatment landscape, commanding a solid market position through its unique mechanism of action and demonstrated clinical benefits. While mature markets provide a stable revenue base, upcoming competitive threats and regulatory challenges necessitate strategic positioning and innovation. Bayer’s continued investment in clinical research and market access will be critical in sustaining its financial trajectory and maximizing its therapeutic potential.

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Key Takeaways

• The global prostate cancer market is expanding due to demographic shifts and treatment advancements, favoring the growth of targeted agents like XOFIGO.
• Clinical efficacy, safety, and guideline endorsements position XOFIGO as a critical option for bone-metastatic mCRPC, underpinning consistent revenue growth.
• Competition from newer radiopharmaceuticals, systemic therapies, and combination regimens presents significant challenges; companies must innovate to maintain market share.
• Logistics and manufacturing complexities associated with radionuclides require sophisticated supply chain management.
• Strategic expansion into new indications, geographies, and combination therapies offers pathways for future growth.

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FAQs

Q1: What distinguishes XOFIGO from other treatments for mCRPC?

A1: XOFIGO uniquely delivers targeted alpha radiation specifically to bone metastases, providing a high radiation dose with limited damage to surrounding tissues, resulting in improved survival and quality of life compared to traditional therapies.

Q2: What are the primary markets driving XOFIGO sales?

A2: North America, particularly the U.S., and Europe are the leading markets owing to established healthcare infrastructure, reimbursement policies, and clinical guideline support.

Q3: How significant is the competition from emerging radiopharmaceuticals?

A3: Emerging agents, such as actinium-225 radiopharmaceuticals, could threaten XOFIGO’s market share if they demonstrate superior efficacy, safety, or ease of use; however, regulatory and logistical hurdles currently limit their widespread adoption.

Q4: Can XOFIGO be used in combination with other therapies?

A4: Current studies are exploring combinations with immunotherapies, chemotherapy, and hormonal agents. Positive outcomes could enhance its therapeutic profile and drive market expansion.

Q5: What are the regulatory prospects for XOFIGO’s indication expansion?

A5: Pending successful clinical trials, Bayer aims to extend XOFIGO’s approval to earlier stages of prostate cancer and other metastatic settings, potentially broadening its commercial applicability.

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References

1. IARC. Global Cancer Statistics 2020.
2. IARC. Estimated Incidence of Prostate Cancer Worldwide, 2020.
3. ASCO/ESMO Guidelines on mCRPC Treatment.
4. Parker C, et al. ALSYMPCA Study Final Results. The New England Journal of Medicine. 2013.
5. Krajewska J, et al. Radiopharmaceuticals in mCRPC. Clin Oncol. 2022.