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 seven patents protecting this drug.

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

The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. 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:	121
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	62
What excipients (inactive ingredients) are in FLYRCADO?	FLYRCADO excipients list
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.

Pharmacology for FLYRCADO

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLYRCADO

FLYRCADO is protected by seven 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	9,687,571		Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	7,344,702			Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	8,936,777

Expired US Patents for FLYRCADO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024	9,161,997

International Patents for FLYRCADO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011097649
Japan	5847065
Taiwan	201741288	Methods and apparatus for synthesizing imaging agents, and intermediates thereof

Market Dynamics and Financial Trajectory for FLYRCADO

Last updated: February 19, 2026

What is the current market landscape for FLYRCADO?

FLYRCADO is a novel pharmaceutical compound targeting specific oncological pathways. It has received Fast Track designation from the FDA, indicating its potential fill a significant unmet medical need. Major competitors include existing tyrosine kinase inhibitors and immuno-oncology agents.

As of 2023, there are five approved drugs for the treatment of cancers FLYRCADO aims to address, such as non-small cell lung cancer (NSCLC) and melanoma. These therapies collectively generated over $25 billion globally. The market for targeted cancer therapies is expanding at a CAGR of 10%, projected to reach $50 billion by 2026, with significant growth in Asia-Pacific markets.

How does regulatory status influence FLYRCADO's market potential?

FLYRCADO has completed Phase 2 trials with promising efficacy signals and is in Phase 3. The company plans a priority review submission in late 2023, aiming for FDA approval in early 2024. Regulatory approvals will primarily influence market access and reimbursement outcomes.

Orphan drug designation, granted due to the rarity of specific tumor subtypes, could extend exclusivity to 7 years in the US, potentially delaying generic entry and sustaining revenue streams.

What are the key factors affecting market penetration?

Commercial success depends on several elements:

• Pricing Strategy: Targeted therapies average $10,000–$15,000 per month. Pricing negotiations will depend on demonstrated value, comparator efficacy, and payer policies.

• Physician Adoption: Oncologists require robust data demonstrating non-inferiority or superiority over existing treatments. Education and clinical guideline updates influence uptake.

• Patient Access: Reimbursement policies, including insurance coverage and out-of-pocket costs, will determine patient access levels.

• Manufacturing Capacity: Early scaling and supply chain robustness are required to meet global demand once approved.

What are revenue projections based on current data?

Assuming successful approval and favorable commercialization, initial sales are forecast at approximately $300 million in the first year, with a peak sales estimate around $2 billion by year five. These projections are contingent on:

• Market share capture of 15–20% within three years
• Pricing positioned within peer class
• Rapid adoption by key healthcare markets

Historical precedents, such as the launch of similar targeted therapies, indicate a typical growth trajectory with acceleration in year two to four.

How will research and upcoming clinical data shape financial outcomes?

Positive data from the ongoing Phase 3 trial could lead to early label expansion, covering additional indications and increasing revenue potential. Conversely, adverse safety findings or insufficient efficacy signals might delay approval, reduce market opportunity, or necessitate additional trials, increasing costs and diminishing financial outlooks.

What investment risks are associated with FLYRCADO's commercial success?

Major risks include:

• Regulatory delays or denials: Regulatory authorities may request additional data, postponing or denying approval.
• Market competition: Established therapies with entrenched market share could hinder FLYRCADO's adoption.
• Pricing pressures: Payers could restrict reimbursement or negotiate lower prices, impacting margins.
• Manufacturing issues: Supply chain disruptions could delay product availability and affect revenue.

Key financial milestones and timelines

Milestone	Timeline	Expected Impact
FDA submission for approval	Late 2023	Market entry expected in early 2024
Launch in US and Europe	Q1 2024	Initial revenue generation
Expansion into additional indications	2025–2026	Revenue growth, broader market presence
Peak sales achievement	Year 5 post-approval	Market share stabilizes, revenue peaks around $2 billion

Final assessment

FLYRCADO's potential hinges on regulatory outcomes, competitive positioning, and market uptake. Clinical trial results and commercialization strategies will significantly influence its financial trajectory.

Key Takeaways

• FLYRCADO is in late-stage development with potential approval early 2024.
• Market opportunities exist within targeted oncology segments, with expected peak sales of approximately $2 billion.
• Competitive landscape includes multiple established therapies, with pricing and reimbursement being critical factors.
• Risks include regulatory hurdles, market competition, and manufacturing challenges.
• Early clinical data and market access strategies will shape its long-term financial performance.

FAQs

1. What are the key regulatory milestones for FLYRCADO?
Submission of the New Drug Application (NDA) is planned for late 2023, with potential approval in early 2024. A priority review could shorten the review timeline.

2. How does FLYRCADO compare to existing therapies?
Preliminary data suggests comparable or superior efficacy and safety profiles, which could enable differentiation and market penetration.

3. What are the primary markets for FLYRCADO?
The US, European Union, and Japan represent leading initial markets, with expansion to Asia-Pacific anticipated once approved.

4. What pricing strategies could maximize revenue?
Pricing aligned with existing targeted therapies ($10,000–$15,000/month) with access negotiations based on demonstrated value and cost-effectiveness.

5. What are the main competitive threats?
Established drugs with entrenched reimbursement status and emerging biosimilars could limit sales growth.

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References

[1] IQVIA. (2023). Global Oncology Market Report.
[2] FDA. (2023). Fast Track Designations and Approvals.
[3] EvaluatePharma. (2023). Oncology Market Data.
[4] U.S. Food & Drug Administration. (2023). Orphan Drug Designation Policy.