piflufolastat f-18 - Profile

What are the generic drug sources for piflufolastat f-18 and what is the scope of patent protection?

Piflufolastat f-18 is the generic ingredient in two branded drugs marketed by Progenics Pharms Inc and Aphelion, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Piflufolastat f-18 has one hundred and eighteen patent family members in twenty-seven countries.

Summary for piflufolastat f-18

International Patents:	118
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for piflufolastat f-18

Dosage:

SOLUTION;INTRAVENOUS

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 piflufolastat f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes			Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes			Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes			Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes			Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes			Y	Y

International Patents for piflufolastat f-18

Country	Patent Number	Title	Estimated Expiration
Canada	3026889
Canada	3240630
China	109563038
China	122187723
China	122187724

Supplementary Protection Certificates for piflufolastat f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	LUC00323	Luxembourg		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	CR 2023 00032	Denmark		PRODUCT NAME: PIFLUFOLASTAT (18F) ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1746 20230725
2318366	C202330040	Spain		PRODUCT NAME: PIFLUFOLASTATO (18F) O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1746; DATE OF AUTHORISATION: 20230724; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1746; DATE OF FIRST AUTHORISATION IN EEA: 20230724
2318366	PA2023534	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023

Investment Scenario, Market Dynamics, and Financial Trajectory for Piflufolastat F-18

Last updated: February 3, 2026

Executive Summary

Piflufolastat F-18 (commercial name: Pylarify) is a radiotracer developed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) in prostate cancer patients. Since its FDA approval in May 2021, Pylarify has gained accelerating adoption in diagnostic imaging, establishing a significant niche within nuclear medicine. This analysis evaluates investment opportunities, market conditions, competitive environment, R&D and manufacturing costs, and financial projections to guide stakeholders and investors.

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What Is Piflufolastat F-18?

Aspect	Details
Chemical Name	piflufolastat F-18 (also known as 18F-DCFPyL)
Indication	PET imaging for detection of prostate carcinoma metastases and recurrence
Regulatory Status	FDA approved (May 2021), CE-marked, approved in multiple regions
Mechanism	PSMA-targeted radiotracer binding to prostate cancer cells

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Market Overview

Global Prostate Cancer Imaging Market (2022-2032)

Year	Market Size (USD Billion)	CAGR (%)	Notes
2022	$0.80	10.5	Steady growth post-approval
2027	$1.60	10.5	Expected doubling driven by adoption
2032	$3.20	10.6	Projected market expansion

The worldwide prostate cancer diagnostics market was valued at approximately $6.5 billion in 2022, with imaging accounting for roughly 12%. Piflufolastat F-18 captures a growing segment due to:

• Rising prostate cancer prevalence (~1.3 million new cases globally, 2022) [1].
• Increasing adoption of PSMA PET imaging over conventional scans (e.g., bone scan, CT, MRI).
• Regulatory approvals expanding geographic access.

Key Market Drivers

• Prostate Cancer Incidence: Expected to rise at 3.8% annually [2].
• Reimbursement Reforms: CMS expanded Medicare coverage for PSMA PET scans in 2022.
• Technological Advancements: Improved PET scanners (machine sensitivity).

Market Challenges

• High costs of PET imaging (per scan: $2,500–$4,000).
• Limited availability of PSMA PET agents in low-income regions.
• Competition from other prostate-specific imaging agents.

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Competitive Environment

Product	Developer	Approval Date	Market Share (Estimated)	Key Features
Pylarify	Novartis	May 2021 (FDA)	~50% in US	High specificity for PSMA, broad access
Ga-68-PSMA-11	Various (e.g., MIT, Telix)	2020	~30% in US	Off-label use, limited distribution
Fluorine-18-PSMA Agents	Multiple	Ongoing	Niche	Longer half-life (110 min), easier logistics

Market Positioning:
Pylarify benefits from early regulatory approval, established manufacturing, and reimbursement pathways, giving it a competitive edge over earlier or alternative agents.

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Investment Scenario Analysis

Revenue Projections (2022–2032)

Year	Estimated Annual Revenue (USD Million)	Assumptions
2022	$150	Initial post-approval adoption in US & Europe
2023	$250	Increased global adoption, expanding commercial footprint
2027	$600	Mature market saturation, stable growth, expansion into Asia-Pacific
2032	$1,200	Global penetration, increasing prostate cancer diagnosis rates

Factors Influencing Revenue Growth

• Market Penetration: Growing utilization in North America, Europe, and Asia.
• Pricing Strategy: Per-scan price (~$3,000), potential discounts for volume sales.
• Manufacturing Capacity: Scaling up F-18 production, including supply chain stability.
• Reimbursement Policies: Coverage expansion accelerates uptake.
• Clinical Evidence: Confirmatory studies improving confidence and indications.

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Cost Structure and Profitability

Cost Category	Approximate % of Revenue	Details
Manufacturing	25–30%	F-18 production, quality control
Regulatory & Compliance	8–10%	Submissions, audits, pharmacovigilance
Distribution & Logistics	10%	Cold chain logistics, storage
Sales & Marketing	15–20%	Education, sales force expansion
R&D & Pipeline Development	5–8%	Ongoing studies, new indications

Gross margin is estimated at ~70%, with net margins potentially reaching ~40% in mature stages.

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Financial Trajectory and Investment Opportunities

Investment Dimension	Outlook
Initial Investment	Capital required for scaling manufacturing, regulatory expansion, commercial infrastructure (~$250M for large-scale operation over 3 years)
Return on Investment (ROI)	Projected to reach 15–20% net margins by 2026, with revenues doubling every 3–4 years
Licensing & Partnerships	Potential for licensing deals with regional partners, especially in emerging markets
Exit Strategies	M&A, IPO, or strategic sale projected by 2030

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Key Market Trends & Future Outlook

Emerging Market Expansion

• China, India, and Southeast Asia showing rapid prostate cancer prevalence.
• Local manufacturing and regulatory approvals are critical.

Innovation and Pipeline Development

• Development of next-generation PSMA agents with improved pharmacokinetics.
• Theranostic combinations (e.g., Piflufolastat F-18 with therapeutic isotopes).

Regulatory Trends

• Broader global approval pathways expected, especially with positive clinical validation.
• Increased reimbursement policies favoring advanced imaging.

Potential Disruptors

• Alternative imaging modalities (e.g., advanced MRI techniques).
• New radiotracers with superior specificity or lower cost.

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Comparison with Alternatives

Agent	Modality	Half-Life	Approval Year	Key Advantage	Market Penetration
Pylarify (F-18)	PET	110 min	2021	Broad logistics, high specificity	Rapidly growing
Ga-68-PSMA-11	PET	68 min	2020	Established in Europe, off-label US use	Niche but expanding
Imaging via MRI/CT	CT/MRI	N/A	Ongoing	No radiation, lower cost	Ubiquitous

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FAQs

1. What is the expected timeline for Pylarify's market growth?

Market penetration is anticipated to accelerate through 2025, with revenues reaching approximately $600 million globally by 2027 as adoption expands beyond North America and Europe.

2. How does the cost of producing Piflufolastat F-18 impact profitability?

F-18 production costs are approximately 25–30% of revenue, with economies of scale and improved synthesis techniques expected to reduce costs over time, improving industry margins.

3. What are the primary regulatory hurdles for expanding Pylarify’s market access?

Regulatory hurdles include regional approval processes, demonstration of clinical utility, and reimbursement policies. Streamlined approval paths via mutual recognition agreements may facilitate faster market access.

4. What competitive advantages does Pylarify hold over similar agents?

Pylarify's advantages include broader logistical flexibility due to F-18's half-life, early market entry, established manufacturing infrastructure, and favorable reimbursement in several regions.

5. Which emerging markets present the highest growth potential for Piflufolastat F-18?

China, India, and Southeast Asia are prioritized due to rising prostate cancer prevalence, expanding healthcare infrastructure, and increasing access to nuclear medicine.

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Key Takeaways

• Piflufolastat F-18 (Pylarify) is positioned for rapid global expansion in prostate cancer imaging, with projected revenues doubling every few years.
• The agent’s logistical advantages, backed by regulatory approval and reimbursement, provide a competitive edge.
• A significant investment is warranted for manufacturing scale-up, clinical validation, and market expansion, with mature margins expected by 2026.
• Market expansion into emerging regions is critical, leveraging local manufacturing and regulatory strategies.
• Ongoing clinical research and pipeline development could reinforce Pylarify’s market dominance and open new theranostic opportunities.

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References

1. Globocan 2022: Prostate Cancer Statistics. International Agency for Research on Cancer.
2. American Cancer Society. Prostate Cancer Facts & Figures 2022–2023.

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