XOFIGO Drug Patent Profile

When do Xofigo patents expire, 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
Barbara Ann Karmanos Cancer Institute	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	6,635,234

International Patents for XOFIGO

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	513135	The preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Portugal	1140212
Luxembourg	92425
Norway	310544

Supplementary Protection Certificates for XOFIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140212	92425	Luxembourg		PRODUCT NAME: DICHLORURE DE RADOIM RA 2232 ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(XOFIGO)
1140212	33/2014	Austria		PRODUCT NAME: RADIUM-223-DICHLORID; REGISTRATION NO/DATE: EU/1/13/873 20131113
1140212	CA 2014 00027	Denmark		PRODUCT NAME: RADIUM-223 OG OPLOESELIGE SALTE DERAF, HERUNDER RADIUM-223 DICHLORID; REG. NO/DATE: EU/1/13/873 20131113
1140212	122014000052	Germany		PRODUCT NAME: RADIUM-223-SALZ, INSBESONDERE RADIUM-223-DICHLORID; REGISTRATION NO/DATE: EU/1/13/873 20131113

XOFIGO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Xofigo

Introduction to Xofigo

Xofigo, also known as radium-223 dichloride, is a groundbreaking alpha-particle-emitting radiopharmaceutical approved by the FDA on May 15, 2013, for the treatment of men with castration-resistant prostate cancer (CRPC) that has spread to the bones but not to other organs[3][5].

Clinical Significance and Efficacy

Xofigo has demonstrated significant clinical efficacy in improving overall survival for patients with CRPC. The ALSYMPCA clinical trial, a double-blind, randomized, placebo-controlled phase III study, showed that Xofigo extended overall survival by 3.6 months compared to the best standard of care (BSOC) alone. The median overall survival was 14.0 months for patients receiving Xofigo plus BSOC versus 11.2 months for those receiving BSOC alone[4].

Market Demand and Growth

Since its approval, Xofigo has seen steady and robust growth in demand. In the US, over 500 doses of Xofigo are ordered per week, highlighting its strong market acceptance and the growing need for effective treatments for CRPC[1].

Financial Performance

The financial trajectory of Xofigo has been impressive, contributing significantly to the revenue growth of its manufacturer, Bayer HealthCare. In the first three quarters of 2015, Xofigo sales rose by 46.9% year-over-year, reaching €188 million. This growth was part of a broader increase in Bayer HealthCare's sales, which rose by 24.3% year-over-year during the same period[2].

Revenue Projections and Analyst Estimates

Analysts have projected Xofigo to achieve near-blockbuster annual sales, with estimates suggesting it could generate around €494 million ($668 million) annually. This makes Xofigo one of the key drug launches for Bayer, with a combined sales potential of over €5.5 billion ($7.4 billion) when including other new drugs[5].

Acquisition and Partnership Dynamics

Bayer's interest in Xofigo extended beyond its commercial success, leading to a $2.4 billion takeover bid for Algeta, the Norwegian company that co-developed Xofigo. This acquisition aimed to consolidate Bayer's control over the drug and its future revenue, eliminating the need for profit-sharing and royalties under their previous collaboration agreement[5].

Global Market Expansion

Xofigo has received marketing authorization not only in the US but also in the European Union, further expanding its global reach. The drug's approval under the FDA's priority-review program and its subsequent EU marketing authorization have facilitated its rapid integration into clinical practice worldwide[3][5].

Impact on Bayer's Financials

The strong performance of Xofigo has significantly contributed to Bayer's overall financial growth. In the third quarter of 2015, Bayer's group sales increased by 10.7% year-over-year, with the HealthCare division, which includes Xofigo, seeing a 24.3% year-over-year increase in net sales. This growth underscores the importance of Xofigo and other new pharmaceuticals in Bayer's financial strategy[2].

Research and Development

The success of Xofigo has also fueled research into additional alpha-emitting therapeutic agents. The high potency and specificity of alpha particles make them an attractive option for targeted therapies, and Bayer's investment in this area is expected to continue, driven by the positive outcomes seen with Xofigo[1].

Educational and Implementation Challenges

Despite its clinical and financial success, the implementation of Xofigo faces educational challenges. Technologists and healthcare professionals need to understand the treatment schedule, hematologic eligibility requirements, and the unique benefits of alpha emitters compared to beta emitters. Addressing these educational gaps is crucial for maximizing the drug's potential[1].

Future Outlook

Given its strong market performance, clinical efficacy, and the ongoing research in alpha-emitting therapies, Xofigo is poised to remain a significant player in the treatment of CRPC. As Bayer continues to invest in life sciences and expand its product portfolio, Xofigo is expected to contribute substantially to the company's future growth and financial success.

Key Takeaways

• Clinical Efficacy: Xofigo significantly improves overall survival for patients with CRPC.
• Market Demand: Strong demand with over 500 doses ordered per week in the US.
• Financial Performance: Contributed to a 46.9% year-over-year sales increase for Bayer HealthCare.
• Global Expansion: Approved in the US and EU, with global marketing efforts.
• Acquisition Dynamics: Bayer's acquisition of Algeta to consolidate control over Xofigo.
• Future Outlook: Expected to continue contributing to Bayer's growth and financial success.

FAQs

What is Xofigo used for?

Xofigo is used for the treatment of men with castration-resistant prostate cancer (CRPC) that has spread to the bones but not to other organs.

How does Xofigo work?

Xofigo is an alpha-particle-emitting radiopharmaceutical that selectively targets and kills tumor cells in the bones, leaving surrounding normal tissues unharmed.

What were the key findings of the ALSYMPCA clinical trial?

The ALSYMPCA trial showed that Xofigo extended overall survival by 3.6 months compared to the best standard of care alone, with a median overall survival of 14.0 months for Xofigo plus BSOC versus 11.2 months for BSOC alone.

Why did Bayer acquire Algeta?

Bayer acquired Algeta to consolidate control over Xofigo, eliminating the need for profit-sharing and royalties under their previous collaboration agreement and gaining access to Algeta's pipeline of radiation therapy candidates.

What is the projected annual sales potential of Xofigo?

Analysts estimate that Xofigo could generate around €494 million ($668 million) in annual sales.

Cited Sources

1. Journal of Nuclear Medicine: "Xofigo: An exciting new therapy for prostate cancer"
2. S&P Global Market Intelligence: "New product sales push Bayer HealthCare's revenue up 24.3% y/y"
3. PR Newswire: "Bayer Receives U.S. FDA Approval for Xofigo® (radium Ra 223 dichloride) Injection as a New Treatment for Castration-Resistant Prostate Cancer with Bone Metastases"
4. Xofigo HCP: "Overall Survival (OS) - Xofigo® (Radium Ra 223 Dichloride)"
5. Genetic Engineering & Biotechnology News: "Bayer Makes $2.4B Takeover Bid for Xofigo Partner Algeta"