FLOTUFOLASTAT F-18 GALLIUM - Generic Drug Details

What are the generic drug sources for flotufolastat f-18 gallium and what is the scope of freedom to operate?

Flotufolastat f-18 gallium is the generic ingredient in one branded drug marketed by Blue Earth and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flotufolastat f-18 gallium has thirty patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for FLOTUFOLASTAT F-18 GALLIUM

International Patents:	30
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	FLOTUFOLASTAT F-18 GALLIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLOTUFOLASTAT F-18 GALLIUM

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;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.

Pharmacology for FLOTUFOLASTAT F-18 GALLIUM

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLOTUFOLASTAT F-18 GALLIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	12,036,290		Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes	11,413,360			Y

International Patents for FLOTUFOLASTAT F-18 GALLIUM

Country	Patent Number	Title	Estimated Expiration
South Korea	20200064057	이중 모드 방사성 트레이서 및 치료법
Japan	7059372
Brazil	112020001785	radiotraçador e compostos radioterapêuticos bimodais

FLOTUFOLASTAT F-18 GALLIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLOTUFOLASTAT F-18 GALLIUM

Introduction to FLOTUFOLASTAT F-18 GALLIUM

FLOTUFOLASTAT F-18 GALLIUM, marketed as POSLUMA, is a radioactive diagnostic agent used in positron emission tomography (PET) for the detection of prostate cancer. It targets the prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells[2].

Market Segmentation and Share

Product Segment

In the U.S. prostate cancer nuclear medicine diagnostics market, fluorine-18 (F-18) based products, including FLOTUFOLASTAT F-18 GALLIUM, dominate the market. As of 2022, F-18 held a significant market share of approximately 74.22% due to its efficient bio-distribution and relatively low urinary excretion[1][4].

Competitive Landscape

The market for radiopharmaceuticals, particularly those targeting prostate cancer, is competitive with key players such as Blue Earth Diagnostics, Siemens Healthcare, Cardinal Health, CURIUM PHARMA, and Lantheus. These companies are actively involved in product development, strategic initiatives, and financial performance optimization[4].

Market Size and Growth Projections

Current Market Size

The U.S. prostate cancer nuclear medicine diagnostics market was estimated at USD 75.06 million in 2022 and is expected to reach USD 83.18 million in 2023. This market is projected to grow significantly over the coming years[1].

Growth Projections

The market is anticipated to grow at a compound annual growth rate (CAGR) of 9.2% from 2023 to 2030, reaching USD 153.97 million by 2030. This growth is driven by the increasing incidence of prostate cancer, advancements in diagnostic technologies, and the efficacy of F-18 based radiotracers like FLOTUFOLASTAT F-18 GALLIUM[1][4].

Cost-Effectiveness and Economic Impact

Cost-Effectiveness Modeling

A recent study suggests that FLOTUFOLASTAT F-18 GALLIUM is a cost-effective diagnostic option for men with prostate cancer in the U.S. The study found that it offers higher life-years (LY) and quality-adjusted life-years (QALY) compared to other diagnostic options like fluciclovine F-18, gallium68-PSMA-11, and standard of care (SOC) imaging. The incremental cost-effectiveness ratio (ICER) for FLOTUFOLASTAT F-18 GALLIUM was significantly lower, making it a more economically viable choice[5].

Economic Benefits

The study indicated that FLOTUFOLASTAT F-18 GALLIUM was associated with the greatest net monetary benefit at a willingness-to-pay threshold of $150,000. This suggests that the use of FLOTUFOLASTAT F-18 GALLIUM can lead to significant economic savings for the healthcare system while providing better patient outcomes[5].

Pharmacokinetics and Pharmacodynamics

Distribution and Elimination

Following intravenous administration, FLOTUFOLASTAT F-18 GALLIUM distributes primarily to the liver, heart blood pool, and kidneys. It is cleared from the blood without undergoing metabolism up to 50 minutes post-injection. The elimination is primarily through urinary excretion, with approximately 7% of the administered activity excreted in the urine within the first 2 hours post-injection[2].

Diagnostic Efficacy

The radiotracer is effective in detecting prostate cancer due to its ability to target PSMA. The principal photons produced by the decay of fluorine-18 are useful for diagnostic imaging, making it a valuable tool in the initial staging and detection of biochemical recurrence of prostate cancer[2].

Regulatory Approval and Clinical Trials

FDA Approval

FLOTUFOLASTAT F-18 GALLIUM has been approved by the FDA for use in the diagnosis and staging of prostate cancer. This approval is based on clinical trials such as the OSPREY and CONDOR trials, which demonstrated its efficacy and safety[2][5].

Clinical Trials

The clinical trials have shown that FLOTUFOLASTAT F-18 GALLIUM is superior to standard imaging modalities in detecting prostate cancer. These trials have provided robust data supporting its use in clinical practice[5].

Global Radiopharmaceuticals Market Context

Global Market Size and Growth

The global radiopharmaceuticals market, which includes F-18 based products like FLOTUFOLASTAT F-18 GALLIUM, was valued at USD 5.0 billion in 2023 and is projected to grow at a CAGR of 10.4% to reach USD 16.6 billion by 2032. This growth is driven by increasing demand for diagnostic and therapeutic applications in various diseases, including cancer and cardiology[3].

Key Takeaways

• Market Dominance: F-18 based radiotracers, including FLOTUFOLASTAT F-18 GALLIUM, dominate the U.S. prostate cancer nuclear medicine diagnostics market.
• Growth Projections: The market is expected to grow at a CAGR of 9.2% from 2023 to 2030.
• Cost-Effectiveness: FLOTUFOLASTAT F-18 GALLIUM is a cost-effective diagnostic option with higher LY and QALY compared to other options.
• Regulatory Approval: Approved by the FDA based on robust clinical trial data.
• Global Context: Part of a larger global radiopharmaceuticals market expected to grow significantly by 2032.

FAQs

What is FLOTUFOLASTAT F-18 GALLIUM used for?

FLOTUFOLASTAT F-18 GALLIUM is used as a diagnostic agent in positron emission tomography (PET) for the detection and staging of prostate cancer.

What is the market share of F-18 based products in the U.S. prostate cancer diagnostics market?

F-18 based products, including FLOTUFOLASTAT F-18 GALLIUM, held approximately 74.22% of the market share in 2022.

How cost-effective is FLOTUFOLASTAT F-18 GALLIUM compared to other diagnostic options?

FLOTUFOLASTAT F-18 GALLIUM is more cost-effective with lower ICERs and higher net monetary benefits compared to other diagnostic options like fluciclovine F-18 and gallium68-PSMA-11.

What is the expected growth rate of the U.S. prostate cancer nuclear medicine diagnostics market?

The market is expected to grow at a CAGR of 9.2% from 2023 to 2030.

What are the key companies involved in the radiopharmaceuticals market?

Key companies include Blue Earth Diagnostics, Siemens Healthcare, Cardinal Health, CURIUM PHARMA, and Lantheus.

Sources

1. Grand View Research: U.S. Prostate Cancer Nuclear Medicine Diagnostics Market Report.
2. FDA: POSLUMA (flotufolastat F 18) injection label.
3. SNS Insider: Radiopharmaceuticals Market Size, Trends, Opportunities, 2032.
4. Nova One Advisor: U.S. Prostate Cancer Nuclear Medicine Diagnostics Market Share.
5. PubMed: Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Targeted PET Imaging with Piflufolastat F 18.