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 thirteen patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for piflufolastat f-18

International Patents:	113
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
Blue Earth Diagnostics	PHASE4
Aixial Group	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			Y	Y
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
San Marino	T202500007
Japan	5606737
San Marino	T201700371
Portugal	2318366

Supplementary Protection Certificates for piflufolastat f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	PA2023534,C2318366	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	C20230033	Finland
2318366	122023000060	Germany		PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725

Market Dynamics and Financial Trajectory for Piflufolastat F-18

Last updated: July 31, 2025

Introduction

Piflufolastat F-18 (commercial names such as Pylarify) represents a significant advancement in prostate cancer diagnostics, particularly in positron emission tomography (PET) imaging. Approved by the U.S. Food and Drug Administration (FDA) in May 2021, this radiopharmaceutical is designed to improve detection of prostate-specific membrane antigen (PSMA) overexpression in prostate cancer cells [1]. Its innovative profile and clinical efficacy position it as a promising asset within the rapidly expanding molecular imaging market. This article examines the market dynamics, regulatory landscape, competitive environment, and financial prospects for Piflufolastat F-18.

Market Overview

Global Nuclear Medicine and PET Imaging Market

The nuclear medicine and PET imaging market are experiencing robust growth driven by technological advances, increasing adoption in diagnostic pathways, and rising prostate cancer prevalence. The global molecular imaging market was valued at approximately USD 3.8 billion in 2021 and is projected to surpass USD 6 billion by 2027, with a compound annual growth rate (CAGR) of about 8-10% [2].

Prostate Cancer Incidence and Diagnostic Needs

Prostate cancer remains the second-most common cancer among men worldwide. According to the World Health Organization, incidence rates have increased globally, with various regions reporting substantial diagnostic challenges in identifying recurrent or metastatic disease. Conventional imaging modalities such as MRI or bone scans have limitations in sensitivity and specificity, prompting demand for advanced molecular imaging techniques like PSMA PET scans [3].

Piflufolastat F-18 addresses these diagnostic gaps, offering high sensitivity for detecting recurrent prostate cancer. Its approval has catalyzed a shift towards more precise, PSMA-targeted imaging, fostering market expansion.

Market Drivers

Efficacy and Diagnostic Precision

Clinical trials underpin the utility of Piflufolastat F-18, demonstrating superior accuracy over traditional imaging modalities in identifying recurrent disease, especially at low PSA levels. Such efficacy enhances clinical confidence and facilitates earlier, tailored interventions.

Regulatory Approvals and Reimbursement

FDA approval primarily bolstered market confidence, paving the way for reimbursement negotiations. Piflufolastat F-18 benefits from favorable reimbursement scenarios across the U.S., given its diagnostic value and official endorsement—driving widespread adoption [4].

Physician and Institutional Adoption

As awareness of PSMA PET imaging grows among urologists, oncologists, and radiologists, both academic and community practices are integrating these diagnostics. The adoption is further supported by clinical guidelines that increasingly recommend PSMA-based imaging as standard in recurrent prostate cancer assessment.

Competitive Launches and Differentiators

Key competitors include compound agents like Gallium-68 PSMA-11 (approved in Europe, not yet in the U.S.) and Lutetium-177-based therapeutics. Piflufolastat F-18’s straightforward F-18 labeling and longer shelf life offer logistical advantages over Ga-68, which has a shorter half-life and limited supply chain stability [5].

Competitive Landscape

Key Industry Players

• Lantheus Holdings Inc.: The marketer of Pylarify, leveraging its established position in nuclear imaging radiopharmaceuticals.
• Novartis: Provider of Lutetium-177-PSMA therapies, offering a theranostic approach.
• Advanced Radiopharmaceuticals: Developing next-generation PSMA imaging agents and therapeutics.

Strategic Collaborations and Market Penetration

Lantheus capitalizes on strategic partnerships, expanding imaging centers, and advocacy for standardized PSMA PET use, facilitating rapid geographical expansion. The company also invests in physician education and demonstrated clinical benefits collection, further strengthening market presence.

Regulatory and Reimbursement Outlook

Regulatory Milestones

Apart from the FDA, Piflufolastat F-18 has received approvals or investigational status in multiple markets, including Europe and Australia. These approvals, complemented by ongoing real-world evidence collection, are expected to bolster global adoption.

Reimbursement Landscape

In the U.S., Piflufolastat F-18 benefits from favorable Medicare coverage and private insurance reimbursements, critical for clinical deployment. Persistent efforts in demonstrating cost-effectiveness and improved patient outcomes are essential for maintaining reimbursement levels.

Financial Trajectory and Revenue Potential

Initial Sales Performance

Since its launch in 2021, Pylarify has achieved rapid uptake, with the company reporting double-digit million-dollar quarterly sales within the first year—indicative of strong market acceptance [4].

Market Penetration Strategies

Lantheus aims to expand indications, increase clinical utilization, and reinforce its position through targeted marketing and education efforts. The existing infrastructure for radiopharmaceutical distribution further complements these efforts.

Revenue Growth Projections

Analysts project the global PSMA PET imaging market to grow at a CAGR exceeding 10%, supported by expanding indications and increasing awareness. Pylarify’s market share is expected to increase, with revenue potential potentially reaching USD 300-500 million annually by 2030 [6].

Limitations and Risks

Potential hurdles include:

• Competition from alternative PSMA agents.
• Reimbursement restrictions or non-coverage in certain regions.
• Supply chain disruptions affecting availability.
• Regulatory delays regarding additional indications or new approvals.

Future Outlook

Indications Expansion

Ongoing trials explore Piflufolastat F-18 in therapy response assessment, establishing a theranostic paradigm. Future approvals for primary staging or therapy planning could substantively enhance its market size.

Technological and Clinical Innovations

Emerging imaging agents with enhanced specificity, combined diagnostic-therapeutic platforms, and integration into personalized medicine frameworks signal ongoing evolution. Piflufolastat F-18’s adaptability to these advances will influence its market trajectory.

Global Market Penetration

Expanding into Europe, Asia-Pacific, and other emerging markets offers significant growth potential, contingent on regulatory pathways, local clinical adoption, and healthcare infrastructure development.

Conclusion

Piflufolastat F-18 is poised as a transformative agent in prostate cancer diagnostics, with regulatory approval catalyzing rapid market penetration. Its efficacy, logistical advantages, and supportive reimbursement environment underpin promising financial trajectories. Continued expansion, indications, and technological integration will shape its long-term market dominance.

Key Takeaways

• Market Position: Piflufolastat F-18 is establishing a strong foothold in the rapidly expanding PSMA PET imaging segment, driven by superior sensitivity over traditional techniques.
• Growth Drivers: Increasing prostate cancer incidence, guideline endorsements, and reimbursement facilitate adoption.
• Competitive Edge: Its longer half-life and logistical advantages over Ga-68 agents enable broader reach and supply chain flexibility.
• Revenue Potential: With rapid initial sales and projected market growth, Piflufolastat F-18 could generate hundreds of millions annually within a decade.
• Future Strategies: Expanding indications, global expansion, and integration into theranostic applications will be critical to maximizing its market potential.

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FAQs

1. What makes Piflufolastat F-18 a standout in prostate cancer imaging?
Its high affinity for PSMA receptors, favorable pharmacokinetics, and practical logistics related to F-18 labeling give it an accuracy advantage and easier supply compared to Ga-68 agents [1].

2. How does regulatory approval influence the financial prospects of Piflufolastat F-18?
FDA approval serves as a critical validation, facilitating payer coverage, adoption by clinicians, and opening international markets, thus positively affecting revenue growth.

3. What competitive threats could hinder Piflufolastat F-18’s market expansion?
Emerging imaging agents, alternative theranostics, evolving clinical guidelines, and regional regulatory barriers could limit growth.

4. How significant is reimbursement in shaping the financial trajectory?
Reimbursement policies directly impact clinical utilization; favorable reimbursement boosts sales, while restrictions can slow market penetration.

5. What are the future growth prospects for Piflufolastat F-18?
Significant potential exists through indication expansion, international adoption, and integration into theranostic protocols, with the possibility of becoming a standard diagnostic tool for recurrent prostate cancer.

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References

[1] U.S. Food and Drug Administration. (2021). Pylarify (piflufolastat F-18) FDA approval.
[2] MarketsandMarkets. (2022). Molecular Imaging Market Forecast.
[3] World Health Organization. (2020). Prostate Cancer Epidemiology and Trends.
[4] Lantheus Holdings Inc. (2022). Quarterly earnings reports and investor presentations.
[5] Radiological Society of North America. (2022). Comparing PSMA Imaging Agents: Logistics and Clinical Utility.
[6] EvaluatePharma. (2022). Oncology and Radiopharmaceutical Market Outlook.