FLYRCADO Drug Patent Profile

When do Flyrcado patents expire, and what generic alternatives are available?

Flyrcado is a drug marketed by Ge Hlthcare and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and ten patent family members in twenty-two countries.

The generic ingredient in FLYRCADO is flurpiridaz f-18. Additional details are available on the flurpiridaz f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Flyrcado

Flyrcado will be eligible for patent challenges on September 27, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 27, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FLYRCADO

International Patents:	110
US Patents:	6
Applicants:	1
NDAs:	1
DailyMed Link:	FLYRCADO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLYRCADO

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215168

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.

US Patents and Regulatory Information for FLYRCADO

FLYRCADO is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes			Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes			Y	Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes				Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes

International Patents for FLYRCADO

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

Country	Patent Number	Title	Estimated Expiration
Japan	2018076328
Singapore	10201500929X
Japan	6685269
South Korea	20160030589
Japan	5847065
Portugal	3323810
Russian Federation	2631500

FLYRCADO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flyrcado (Flurpiridaz F 18)

Introduction to Flyrcado

Flyrcado, or flurpiridaz F 18, is a novel PET (Positron Emission Tomography) radiotracer recently approved by the FDA for the enhanced diagnosis of coronary artery disease (CAD). This approval marks a significant advancement in cardiac imaging, offering several key advantages over the current standard, SPECT (Single Photon Emission Computed Tomography) MPI (Myocardial Perfusion Imaging)[1][4].

Market Opportunity

The market for Flyrcado is substantial, given the high prevalence of CAD. In the U.S. alone, there are approximately 6 million MPI procedures performed annually. This large addressable market presents a significant revenue potential for GE HealthCare, the company behind Flyrcado[1].

Diagnostic Efficacy

Flyrcado offers superior diagnostic efficacy compared to SPECT MPI. Its longer half-life of 109 minutes allows for off-site production and wider distribution, making PET MPI more accessible. This radiotracer is particularly beneficial for difficult-to-image patients, such as those with high BMI or women, and enables the combination of exercise stress testing with cardiac PET imaging for the first time[1][4].

Market Expansion and Adoption

The approval of Flyrcado is expected to drive a shift in cardiac imaging practices, potentially increasing the adoption of PET MPI over SPECT. This shift could result in more accurate diagnoses and better patient outcomes. GE HealthCare is working with contract cyclotron vendors to ensure that Flyrcado will be available to 90% of regions with PET centers by the end of 2025[1][4].

Financial Implications

Revenue Potential

As a novel and superior product, Flyrcado could command premium pricing, contributing significantly to GE HealthCare's revenue growth. The substantial addressable market and the potential for higher pricing due to its advanced diagnostic capabilities make it a lucrative addition to GE HealthCare's Pharmaceutical Diagnostics segment[1].

Market Growth

The advantages of Flyrcado may drive overall market growth for cardiac PET imaging. This expansion could attract more patients and healthcare providers to adopt PET MPI, further increasing the market size and revenue potential for GE HealthCare[1].

Competitive Position

The approval of Flyrcado strengthens GE HealthCare's position in the molecular imaging market. By offering a superior diagnostic tool, GE HealthCare can differentiate itself from competitors and solidify its market leadership[1].

Royalty Obligations

While GE HealthCare has exclusive global commercialization rights for Flyrcado, the company will have to pay royalties to Lantheus, which could impact its profit margins. However, the overall revenue potential is expected to outweigh these costs[1].

Launch and Market Preparation

Flyrcado is set to be available in initial U.S. markets in early 2025, with expanding availability thereafter. This planned rollout allows time for market preparation and potential inclusion in clinical guidelines, which is crucial for widespread adoption and long-term commercial success[1][4].

Financial Performance of GE HealthCare

GE HealthCare's financial performance has been strong, with organic revenue growth and improved margins. The company's adjusted EBIT margin increased by 10 basis points, and it delivered an adjusted EPS of $1.14, up 15% year-over-year. The healthy backlog and strong free cash flow generation indicate a solid financial foundation to support the launch and growth of Flyrcado[5].

Investment Landscape in Pharmaceutical Research

The pharmaceutical sector, including diagnostic tools like Flyrcado, is characterized by high development costs and risks but also offers substantial rewards. The global pharmaceutical market is projected to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases. This growth trend underscores the potential for innovative diagnostic tools like Flyrcado to contribute significantly to the revenue and growth of pharmaceutical companies[3].

Industry Trends and Future Outlook

The approval of Flyrcado aligns with GE HealthCare's strategy to innovate in high-value diagnostic areas. This strategy is expected to enhance shareholder value and drive growth in the company's Pharmaceutical Diagnostics segment. As the healthcare industry continues to evolve, the demand for advanced diagnostic tools is likely to increase, positioning Flyrcado for long-term success[1][5].

Key Takeaways

• Market Opportunity: Flyrcado addresses a substantial market with approximately 6 million MPI procedures annually in the U.S.
• Diagnostic Efficacy: Offers superior diagnostic accuracy compared to SPECT MPI, especially for challenging patients.
• Market Expansion: Expected to drive a shift towards PET MPI, increasing market size and revenue potential.
• Financial Implications: Potential for premium pricing, significant revenue growth, and strengthened competitive position.
• Launch and Market Preparation: Initial U.S. launch in early 2025 with expanding availability thereafter.
• Financial Performance: Supported by GE HealthCare's strong financial foundation and growth in the Pharmaceutical Diagnostics segment.

FAQs

What is Flyrcado, and how does it differ from current diagnostic tools?

Flyrcado, or flurpiridaz F 18, is a novel PET radiotracer approved for the diagnosis of coronary artery disease. It offers superior diagnostic efficacy compared to SPECT MPI, with a longer half-life and the ability to combine with exercise stress testing.

What is the market potential for Flyrcado?

The market potential for Flyrcado is substantial, with approximately 6 million MPI procedures performed annually in the U.S., offering a significant revenue opportunity.

How will Flyrcado impact GE HealthCare's financial performance?

Flyrcado is expected to drive revenue growth and strengthen GE HealthCare's position in the molecular imaging market. It could command premium pricing and contribute to the growth of the Pharmaceutical Diagnostics segment.

When will Flyrcado be available in the market?

Flyrcado is set to be available in initial U.S. markets in early 2025, with expanding availability thereafter.

What are the key advantages of Flyrcado over SPECT MPI?

Key advantages include higher diagnostic accuracy, a longer half-life enabling wider distribution, the ability to combine with exercise stress testing, and improved imaging for challenging patients.

Sources

1. GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease. Stock Titan.
2. Quarterly Report for Quarter Ending September 30, 2024 (Form 10-Q). Public Now.
3. Investment Trends in Pharmaceutical Research and Development. DrugBank Blog.
4. FDA approves GE HealthCare's flurpiridaz F-18 PET radiotracer for CAD. Cardiovascular Business.
5. GEHC Q3-2024 Earnings Call. Alpha Spread.