RADIUM RA-223 DICHLORIDE - Generic Drug Details

What are the generic sources for radium ra-223 dichloride and what is the scope of patent protection?

Radium ra-223 dichloride is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for RADIUM RA-223 DICHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	35
DailyMed Link:	RADIUM RA-223 DICHLORIDE at DailyMed

Recent Clinical Trials for RADIUM RA-223 DICHLORIDE

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 2
Affiliated Hospital of Jiangnan University	Phase 1/Phase 2
Jiangnan University	Phase 1/Phase 2

See all RADIUM RA-223 DICHLORIDE clinical trials

Pharmacology for RADIUM RA-223 DICHLORIDE

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

US Patents and Regulatory Information for RADIUM RA-223 DICHLORIDE

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 RADIUM RA-223 DICHLORIDE

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	6,635,234

RADIUM RA-223 DICHLORIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Radium Ra-223 Dichloride (Xofigo)

Introduction

Radium Ra-223 dichloride, marketed as Xofigo, is a groundbreaking alpha-particle emitting radiopharmaceutical approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Approval and Regulatory Landscape

The FDA approval of Xofigo was based on the results of the phase 3 ALSYMPCA trial, which demonstrated a significant improvement in overall survival (OS) and a delay in the time to the first symptomatic skeletal-related event compared to placebo[1][3][4].

Market Adoption

Since its approval, Xofigo has been widely adopted as a standard of care for patients with CRPC and bone metastases. It is now included in all prostate cancer guidelines and has received regulatory approval in over 50 countries worldwide[4].

Clinical Efficacy and Patient Outcomes

Xofigo has shown robust clinical efficacy, including a median OS of 14.9 months compared to 11.3 months for the placebo group in the ALSYMPCA trial. It also reduces bone pain, skeletal-related events, and improves quality of life[1][2][4].

Market Demand

Given that approximately 90% of patients with CRPC develop bone metastases, the demand for Xofigo is substantial. The drug's ability to target bone metastases preferentially, delivering intense, localized radiation with minimal impact on healthy bone, has made it a preferred treatment option[4].

Competitive Landscape

Xofigo is the first and only alpha-particle emitting radiopharmaceutical to demonstrate a survival benefit in metastatic prostate cancer. This unique mechanism of action sets it apart from other radiopharmaceuticals like Strontium-89 (Sr-89) and Samarium-153 (Sm-153), which have been used for palliative treatment of bone pain but do not offer a survival advantage[2][4].

Financial Performance

The financial trajectory of Xofigo has been positive since its launch. The drug's inclusion in clinical guidelines and its widespread adoption have driven significant revenue. While exact financial figures are not provided in the sources, the drug's market performance is reflected in its broad acceptance and continued use over the past decade.

Cost-Effectiveness

Studies have shown that Xofigo is not only effective but also cost-effective. It is associated with a lower hospitalization rate and fewer hospitalization days, which can contribute to lower healthcare resource utilization. Cost-effectiveness models have supported these findings, indicating that Xofigo can provide long-term economic benefits alongside its clinical advantages[4].

Adverse Events and Safety Profile

While Xofigo has a favorable safety profile, common adverse events include nausea, diarrhea, vomiting, and peripheral edema. Hematologic laboratory abnormalities such as anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia are also observed. However, the overall incidence of adverse events is lower with Xofigo compared to placebo[3][4].

Real-World Studies and Long-Term Data

Multiple real-world studies have confirmed the efficacy observed in the ALSYMPCA trial, with overall survival ranging from 8.2 months to 29 months. These studies highlight the importance of patient characteristics, completion of all six treatment cycles, and the timing of Xofigo use in the treatment regimen[4].

Future Prospects

As Xofigo continues to be a standard of care for CRPC with bone metastases, its market dynamics are expected to remain strong. Ongoing research and real-world studies are likely to further optimize its efficacy and safety profile, potentially expanding its use in other patient populations.

Key Takeaways

• Approval and Adoption: Xofigo was approved by the FDA in 2013 and has been widely adopted globally.
• Clinical Efficacy: It significantly improves overall survival and reduces skeletal-related events.
• Market Demand: High demand due to the prevalence of bone metastases in CRPC patients.
• Competitive Advantage: Unique alpha-particle emitting mechanism offering a survival benefit.
• Financial Performance: Positive financial trajectory driven by broad clinical acceptance.
• Cost-Effectiveness: Associated with lower healthcare resource utilization.
• Safety Profile: Favorable safety profile with manageable adverse events.

FAQs

Q: What is Radium Ra-223 dichloride (Xofigo) used for?

A: Xofigo is used for the treatment of patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, with no known visceral metastatic disease.

Q: How was Xofigo approved?

A: Xofigo was approved by the FDA based on the results of the phase 3 ALSYMPCA trial, which demonstrated a significant improvement in overall survival and a delay in the time to the first symptomatic skeletal-related event.

Q: What are the common adverse events associated with Xofigo?

A: Common adverse events include nausea, diarrhea, vomiting, and peripheral edema, as well as hematologic laboratory abnormalities such as anemia and thrombocytopenia.

Q: Is Xofigo cost-effective?

A: Yes, Xofigo is associated with lower hospitalization rates and fewer hospitalization days, contributing to lower healthcare resource utilization and making it a cost-effective option.

Q: How does Xofigo compare to other radiopharmaceuticals?

A: Xofigo is the first and only alpha-particle emitting radiopharmaceutical to demonstrate a survival benefit in metastatic prostate cancer, setting it apart from other treatments like Strontium-89 and Samarium-153.

Cited Sources:

1. Value Based Cancer Care: "Xofigo (Radium Ra 223 Dichloride): The First Alpha Particle Emitting Radioactive Agent for the Treatment of Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases"
2. Journal of Nuclear Medicine: "Bone-Seeking Radiopharmaceuticals for Treatment of Osseous Metastases"
3. PubMed: "Radium Ra 223 dichloride injection: U.S. Food and Drug Administration Approval"
4. Harbor Side Studio: "Radium-223: A Decade of Treating Metastatic Castration-Resistant Prostate Cancer"