PIFLUFOLASTAT F-18 - Generic Drug Details

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

Piflufolastat f-18 is the generic ingredient in one branded drug marketed by Progenics Pharms Inc and is included in one NDA. 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 fifteen patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for PIFLUFOLASTAT F-18

International Patents:	115
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	7
What excipients (inactive ingredients) are in PIFLUFOLASTAT F-18?	PIFLUFOLASTAT F-18 excipients list
DailyMed Link:	PIFLUFOLASTAT F-18 at DailyMed

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

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.

Recent Clinical Trials for PIFLUFOLASTAT F-18

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lantheus Medical Imaging	PHASE2
Aixial Group	PHASE4
Blue Earth Diagnostics	PHASE4

See all PIFLUFOLASTAT F-18 clinical trials

Pharmacology for PIFLUFOLASTAT F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

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
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
Hungary	E026216
Hungary	E059436
Spain	2684322

Supplementary Protection Certificates for PIFLUFOLASTAT F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023
2318366	PA2023534,C2318366	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	2023C/540	Belgium		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725

Market Dynamics and Financial Trajectory for Piflufolastat F-18

Last updated: February 17, 2026

Piflufolastat F-18 (also known as F-18 florbetapir or Pylarify) is a radiotracer used in positron emission tomography (PET) imaging for prostate-specific membrane antigen (PSMA)-positive prostate cancer detection. Approved by the FDA in May 2021, it marks a significant development in prostate cancer diagnostics. Its market growth is influenced by clinical adoption, regulatory environment, competition, reimbursement policies, and technological advancements.

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What Are the Key Market Drivers for Piflufolastat F-18?

Clinical Need and Diagnostic Demand

• Prostate cancer ranks as the second most common cancer among men globally.[1] Accurate staging influences treatment and prognosis.
• PSMA PET imaging offers higher sensitivity and specificity compared to conventional imaging (CT, MRI, bone scans). It detects prostate cancer metastases at lower PSA levels.[2]
• Growing adoption of PSMA PET imaging in recurrence detection and initial staging bolsters demand.

Regulatory Approvals and Reimbursement

• FDA approval in the US in May 2021 facilitates market entry.
• Reimbursement policies vary; some coverage by Medicare and private insurers in the US enhances utilization.
• In Europe, regulatory approvals have been granted by CE marking, aiding market penetration.

Advancements in Imaging Technology

• Technological improvements in PET imaging and radiotracer production support broader clinical integration.
• Simplification of radiotracer logistics, with F-18's longer half-life (110 minutes) compared to Gallium-based tracers (68 minutes), increases distribution range.

Market Penetration and Clinical Adoption

• Initial uptake is concentrated in academic centers; commercial distribution expands to community practices.
• Adoption is driven by published clinical data demonstrating superiority over conventional imaging.

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What Challenges or Limitations Affect Piflufolastat F-18's Market?

Competition

• Other PSMA-targeted tracers like Gallium-68 PSMA (e.g., Lutetium-177 PSMA, Ga-68 PSMA-11) compete in the same niche.
• Some tracers are already established, affecting Piflufolastat F-18’s market share.

Production and Distribution Constraints

• As a cyclotron-produced radiotracer, Piflufolastat F-18's distribution is logistics-dependent.
• Short half-life necessitates proximity to production sites, limiting geographic reach unless widespread radiopharmacy networks are established.

Regulatory and Reimbursement Barriers

• Lack of consistent reimbursement policies could hinder widespread adoption.
• Additional regulatory clearances in different jurisdictions may delay commercialization.

Clinical Practice Variance

• Adoption depends on clinician familiarity and acceptance, which may lag behind emerging evidence.

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How Is the Financial Trajectory Shaping Up?

Revenue Forecasts

• The global prostate cancer imaging market was valued at approximately USD 1.2 billion in 2022.[3]
• PSMA PET agents are projected to expand at a CAGR of 24% from 2023 to 2030, driven by clinical validation and expanding indications.[4]
• Piflufolastat F-18 is expected to secure a significant share, potentially generating USD 150–200 million annually by 2027 in the US alone, as uptake accelerates.

Cost and Pricing Factors

• Price per dose ranges between USD 5,000 and USD 10,000, depending on region and provider.
• Cost of radiotracer production, distribution logistics, and regulatory expenses influence profitability.

Market Expansion Outlook

• North America holds the majority share due to advanced healthcare infrastructure and reimbursement.
• Europe represents a growing market, with newer regulatory approvals and increasing adoption.
• Asia-Pacific remains emerging, with growth driven by rising prostate cancer prevalence and infrastructure development.

Key Strategic Moves

• Companies like Novartis (through its affiliate AAA), and UK-based Curium, leverage established distribution channels.
• Potential collaborations with nuclear medicine centers and investments in cyclotron infrastructure could accelerate market penetration.

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Summary of Financial Trajectory

Year	US Revenue (USD millions)	Global Market Share	CAGR (2023–2030)
2023	50-75	15-20%	-
2025	100-150	25-30%	~24%
2027	150-200	35-40%	-

Note: Estimates are based on industry reports and market modeling.

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Key Takeaways

• Piflufolastat F-18 benefits from increased clinical demand for accurate prostate cancer imaging.
• Market growth hinges on expanding clinical adoption, reimbursement, and distribution infrastructure.
• Competition from Gallium-68 PSMA tracers and logistical constraints limit early market penetration.
• Revenue streams are poised for significant growth, potentially reaching USD 200 million annually in North America by 2027.
• Strategic partnerships and infrastructure investments could bolster long-term financial performance.

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FAQs

1. How does Piflufolastat F-18 compare to other PSMA PET tracers?
It offers logistical advantages due to F-18's longer half-life, facilitating wider distribution. Clinical efficacy is comparable or superior to Gallium-68 tracers.

2. What are the primary barriers to wider adoption?
Logistical challenges, reimbursement policies, clinician familiarity, and competition from established tracers.

3. Will reimbursement policies impact future revenues?
Yes. Coverage determination significantly influences uptake; positive reimbursement decisions will enhance market growth.

4. How does the manufacturing process affect market distribution?
Cyclotron dependency requires proximity to production facilities, limiting geographic reach without extensive radiopharmacy networks.

5. What are future growth prospects beyond 2027?
Expansion into new indications, combination imaging approaches, and regional market penetration are expected to sustain growth.

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References

[1] World Health Organization, "Cancer Fact Sheet," 2022.

[2] Rowe, S.P., et al., "Prostate-specific membrane antigen PET imaging in prostate cancer," Nat Rev Urol, 2022.

[3] MarketsandMarkets, "Prostate Cancer Imaging Market," 2022.

[4] Grand View Research, "PSMA PET Imaging Market Forecast," 2023.