PYLARIFY Drug Patent Profile

Which patents cover Pylarify, and when can generic versions of Pylarify launch?

Pylarify is a drug marketed by Progenics Pharms Inc and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Pylarify

Pylarify was eligible for patent challenges on May 26, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 21, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PYLARIFY

International Patents:	113
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	5
Patent Applications:	129
Drug Prices:	Drug price information for PYLARIFY
What excipients (inactive ingredients) are in PYLARIFY?	PYLARIFY excipients list
DailyMed Link:	PYLARIFY at DailyMed

See drug prices for PYLARIFY

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

Constraining patent/regulatory exclusivity:

8,778,305

NDA:

214793

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 PYLARIFY

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

Sponsor	Phase
Oregon Health and Science University	Phase 4
OHSU Knight Cancer Institute	Phase 4
Progenics Pharmaceuticals, Inc.	Phase 4

See all PYLARIFY clinical trials

Pharmacology for PYLARIFY

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for PYLARIFY

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

This potential generic entry date is based on patent 8,778,305.

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
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	8,778,305		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	11,851,407		Y	Y

International Patents for PYLARIFY

When does loss-of-exclusivity occur for PYLARIFY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Hong Kong

Hungary

Japan

Lithuania

Netherlands

Norway

Poland

Portugal

Russian Federation

San Marino

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PYLARIFY around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2097111
South Korea	102558962
Japan	7427703

Supplementary Protection Certificates for PYLARIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	23C1044	France		PRODUCT NAME: PIFLUFOLASTAT (18F) OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION 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	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 PYLARIFY: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

PYLARIFY (piflufolglutatide F-18) stands out in the evolving landscape of molecular imaging agents, primarily employed in positron emission tomography (PET) scans for prostate-specific membrane antigen (PSMA) detection. As a radiopharmaceutical pioneered by Lantheus Holdings, PYLARIFY captures the essence of targeted cancer imaging, offering significant clinical advantages over traditional imaging modalities. Its market dynamics hinge on advanced technological integration, shifting clinical paradigms, and regulatory pathways, collectively shaping its financial trajectory.

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Market Overview

The Growing Need for Precision Oncology Imaging

The global oncology imaging market, forecasted to surpass USD 8 billion by 2025 ([1]), underpins the demand for targeted diagnostic tools like PYLARIFY. Prostate cancer remains the second most common cancer among men worldwide, with over 1.4 million new cases in 2020 ([2]). Accurate staging and restaging are crucial for tailored treatment, positioning PSMA PET imaging as a pivotal innovation.

Regulatory Milestones and Market Access

In May 2022, the US Food and Drug Administration (FDA) approved PYLARIFY for PET imaging of prostate cancer, a milestone that accelerates clinical adoption ([3]). Concurrently, European Medicines Agency (EMA) approvals and reimbursement strategies across key markets like the US, Europe, and Asia-Pacific are vital determinants of market penetration and revenue potential.

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Market Dynamics Influencing PYLARIFY

Competitive Landscape

The primary competitor for PYLARIFY is Novartis’ Gallium-68 PSMA-11, also approved for prostate cancer imaging. Although Gallium-68 PSMA-11 benefits from prior approvals, PYLARIFY offers advantages, including flexible production, broader geographic access, and established supply chains, facilitating faster integration into existing clinical workflows ([4]).

New entrants and emerging tech, including fluorine-18 labeled PSMA agents like Pylarify, expand the competitive landscape. The longer half-life (110 minutes) of fluorine-18 compared to gallium-68 (68 minutes) enhances distribution and flexibility, favoring PYLARIFY's commercial reach.

Reimbursement and Pricing Strategies

Reimbursement remains a critical factor. In the US, Medicare and private insurers' coverage decisions significantly influence adoption rates. PYLARIFY's inclusion in LCDs (Local Coverage Determinations) and coding updates have improved reimbursement pathways ([5]).

Pricing strategies balance profitability against adoption speed. Given the high costs of PET imaging, value-based pricing models aligned with clinical benefits and payer policies are imperative. Lantheus’ strategy emphasizes demonstrating improved patient outcomes and diagnostic precision to justify premium pricing.

Clinical Adoption and Physician Acceptance

Physician familiarity and confidence in PYLARIFY influence adoption curves. Clinical guidelines from NCCN and other authorities incorporating PSMA PET imaging catalyze clinical workflow integration. The expansion of indications—initially for biochemical recurrence detection and later for primary staging—broadens the addressable patient population.

Supply Chain and Production Capacity

Reliable manufacturing and distribution infrastructure underpin commercial success. Facility investments in radiochemistry production sites enhance supply stability, especially given the short half-life of radiolabeled isotopes. Strategic partnerships with radiopharmacies ensure widespread access to PYLARIFY.

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Financial Trajectory and Revenue Forecasts

Commercial Launch and Growth Drivers

Post-approval, Lantheus aimed for rapid market penetration, emphasizing physician education and payer engagement. Early sales momentum in key markets like the US indicated promising uptake, with initial revenues exceeding projections. The projected CAGR for PYLARIFY’s sales ranges between 20-25% over the next five years, driven by expanding indications, geographic expansion, and increasing clinical acceptance ([6]).

Market Penetration and Revenue Milestones

By 2024, analysts anticipate PYLARIFY generating revenues in the hundreds of millions USD, gradually approaching the low billions as global adoption accelerates ([7]). The growth trajectory is supported by pipeline developments, including potential uses in other neuroendocrine tumors and therapeutic pairings.

Investment and R&D Impact

Lantheus continues investments in R&D to optimize reagent production, develop companion diagnostics, and explore new indications. While such investments may temporarily impact profitability, they are crucial for sustained revenue growth and market leadership.

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Risks and Challenges

• Regulatory Delays: Slow approval processes or unfavorable reimbursement policies could hinder market expansion.
• Competitive Pressure: Rapid advancements by competitors or development of superior agents may impact market share.
• Operational Constraints: Supply chain disruptions, radiopharmacy capacity limitations, or regulatory compliance failures could impede distribution.

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Future Outlook

The outlook for PYLARIFY remains optimistic, driven by technological advantages, expanding clinical evidence, and favorable payer policies. Its strategic positioning as a fluorine-18 labeled agent confers logistical advantages, allowing broader geographic reach and quicker distribution cycles. The continued integration into clinical guidelines and evolving healthcare policies will shape its long-term financial trajectory.

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Key Takeaways

• PYLARIFY’s FDA approval and clinical advantages position it for rapid adoption in prostate cancer imaging, with a forecasted revenue growth rate of approximately 20–25% annually.
• A competitive landscape dominated by Gallium-68 PSMA-11 underscores the importance of logistical advantages, reimbursement strategies, and clinical guideline endorsements for market share expansion.
• Reimbursement policies significantly influence early market penetration; proven clinical value facilitates coverage expansion.
• Investment in supply chain infrastructure and pipeline development enhances growth prospects, with potential applications beyond prostate cancer.
• Regulatory, competitive, and operational risks require ongoing strategic mitigations to sustain long-term financial success.

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FAQs

1. How does PYLARIFY compare to competing PSMA PET imaging agents?
PYLARIFY benefits from fluorine-18 labeling, offering a longer half-life and broader distribution capacity compared to gallium-68 agents like Gallium-68 PSMA-11. It also provides high specificity and imaging resolution, supporting its clinical advantages.

2. What are the main reimbursement considerations for PYLARIFY?
Reimbursement depends on coverage policy updates from CMS and private insurers, coding classifications, and demonstrated clinical utility. Early engagement with payers supports favorable reimbursement pathways.

3. What are the key clinical indications for PYLARIFY?
Initially approved for imaging biochemical recurrence in prostate cancer, expanding indications include primary staging and potentially other tumors expressing PSMA.

4. What regional markets present the greatest growth opportunities for PYLARIFY?
The US remains the primary market, with significant growth potential in Europe, Asia-Pacific, and emerging markets as approval and reimbursement landscapes develop.

5. How might future technological or regulatory developments impact PYLARIFY's market?
Advancements in radiopharmaceutical production, emerging competing agents, and regulatory policies will influence market share, pricing, and overall financial prospects.

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References

[1] Grand View Research, 2022. Oncology Imaging Market Size, Share & Trends.
[2] WHO, 2021. Global Cancer Statistics.
[3] FDA, 2022. FDA Approves PYLARIFY for Prostate Cancer Imaging.
[4] Lantheus Corporate Reports, 2022. Market Position and Competitive Edge of PYLARIFY.
[5] Medicare Coverage Documents, 2022. Inclusion of PYLARIFY in Reimbursement Policies.
[6] Analyst Reports, 2023. Revenue Outlook for PYLARIFY.
[7] Market Intelligence, 2023. Long-Term Growth Projections of PSMA PET Imaging Agents.