PYLARIFY TRUVU Drug Patent Profile

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Which patents cover Pylarify Truvu, and what generic alternatives are available?

Pylarify Truvu is a drug marketed by Aphelion and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in PYLARIFY TRUVU is piflufolastat f-18. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the piflufolastat f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Pylarify Truvu

Pylarify Truvu 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 November 7, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PYLARIFY TRUVU

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
DailyMed Link:	PYLARIFY TRUVU at DailyMed

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

NDA:

220089

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 TRUVU

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 TRUVU clinical trials

Pharmacology for PYLARIFY TRUVU

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for PYLARIFY TRUVU

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

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
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes			Y	Y

International Patents for PYLARIFY TRUVU

When does loss-of-exclusivity occur for PYLARIFY TRUVU?

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

European Patent Office

Hong Kong

Hungary

Japan

Poland

Portugal

Taiwan

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 TRUVU around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3026889
Canada	3240630
China	109563038
China	122187723
China	122187724
Denmark	3481804
European Patent Office	3481804

Supplementary Protection Certificates for PYLARIFY TRUVU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/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	PA2023534	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
2318366	LUC00323	Luxembourg		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	37/2023	Austria		PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 (MITTEILUNG) 20230725
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023

PYLARIFY TRUVU: Market dynamics and financial trajectory

Last updated: May 2, 2026

PYLARIFY TRUVU is a radiopharmaceutical product marketed in the U.S. for prostate cancer patient imaging. The market is shaped by (1) the small addressable patient pool relative to general oncology imaging, (2) tight supply-chain and regulated manufacturing constraints, (3) site-specific reimbursement and procedure economics, and (4) payer and coverage sensitivity to clinical evidence and labeling. The financial trajectory is therefore driven less by broad “volume growth” and more by access: covered indications, hospital ordering behavior, and the ability to maintain consistent supply.

What is the commercial setup for PYLARIFY TRUVU in the U.S.?

Product positioning

• Drug type: radiopharmaceutical (imaging agent)
• Primary use case: imaging in prostate cancer settings (diagnostic and staging workflows)
• Commercial motion: demand concentrates in imaging centers, hospital nuclear medicine departments, and specialty oncology service lines.

Revenue model characteristics (radiopharmaceutical economics)

• Sales typically follow procedure volume and imaging access, not chronic dosing.
• Pricing and margins depend on:
  • site contracts (GPO and IDN contracting)
  • payer reimbursement tied to administered dose and procedure coding
  • wastage and logistics (short shelf-life and cold-chain constraints)
• Supply reliability is a primary performance driver. In radiopharma, even when reimbursement supports use, out-of-stock events cap realizations.

Market structure

• Radiopharma demand concentrates in:
  • hospitals with nuclear medicine infrastructure
  • imaging networks with established ordering and handling workflows
  • oncology practices that manage referral pathways to imaging centers

This concentrates competitive pressure on suppliers that can reliably deliver product at scale to the sites that convert prescriptions into administered imaging studies.

How do patient demand and procedure selection move the market?

Primary demand drivers

1. Prostate cancer incidence and care pathway dynamics

   • The imaging agent demand correlates with the number of patients entering relevant diagnostic or staging workflows.
   • Changes in clinical practice influence ordering behavior, including preference shifts toward imaging agents with favorable diagnostic performance.

2. Clinical guideline adoption and labeling fit

   • Adoption rises when use aligns with payer coverage and physician workflows.
   • Uptake is sensitive to how clinicians interpret evidence and how payers codify coverage.

3. Site capability and turnaround

   • Radiopharmaceuticals require coordination: scheduling, radiopharmacy production lead times, and imaging appointment conversion.
   • Sites with robust nuclear medicine operations capture a larger share of eligible studies.

Constraints that limit linear growth

• Eligibility and sequencing: Imaging use depends on prior treatments, disease state, and physician selection.
• Reimbursement and prior authorization patterns: even with clinical fit, payer friction reduces conversions.

Implication for financial trajectory

• Early and mid-stage growth tends to follow coverage expansion and referral velocity, not just underlying incidence trends.
• Mature dynamics resemble a market share capture problem across hospital networks rather than a population growth story.

What competitive forces shape pricing power and market share?

Competition by modality and workflow Radiopharma competition for prostate cancer imaging is driven by:

• diagnostic yield versus alternatives
• safety and workflow convenience for nuclear medicine departments
• payer coverage positions and claims experience
• supply continuity

Price discipline vs. access

• In radiopharmaceuticals, suppliers often face limited ability to raise prices absent:
  • payer agreement to higher reimbursement
  • superior diagnostic performance recognized by clinical and reimbursement bodies
• Price increases are usually constrained by competitive cross-shopping and procurement leverage in hospitals.

Procurement and contracting

• Hospital procurement through GPO and IDNs can compress realized prices.
• Durable market share requires execution at the contract level, not only at the product level.

How do reimbursement and coverage determine revenue conversion?

Coverage sensitivity

• Payers typically tie access to:
  • approved labeling indications
  • evidence thresholds and clinical criteria
  • prior authorization or documentation requirements
• When coverage narrows, utilization drops faster than incidence increases.

Reimbursement economics

• Radiopharma revenue is realized when:
  • an order converts to an administered study
  • reimbursement supports the cost of the product and associated imaging workflow
  • the site has inventory and capacity to administer on schedule

Implication

• Financial performance depends on the “coverage-to-volume funnel,” where:
  • coverage expands or tightens conversion rates
  • supply reliability prevents “lost studies”
  • contracting determines net pricing

What does the financial trajectory typically look like for this product class?

Without product-specific financial statements in the available record here, the trajectory can only be described through the operating model that governs radiopharmaceutical launch-to-maturity behavior:

Stage-based revenue pattern

1. Launch and early commercialization

   • Revenue is dominated by adoption among early site networks.
   • Growth is often supply-constrained and conversion-friction constrained.

2. Scale-up and reimbursement stabilization

   • Revenue follows coverage breadth, payer acceptance, and stable supply.
   • Contracting and formulary access determine net revenue more than list price.

3. Maturity

   • Revenue growth slows to market share gains across similar sites.
   • Price pressure and inventory management dominate profit trajectory.

Key profit levers

• Gross margin
  • affected by manufacturing cost, yield, and logistics
  • influenced by dose wastage and inventory planning
• SG&A efficiency
  • depends on how effectively sales teams convert eligible physicians and sites
• Operating risk
  • supply reliability and regulatory compliance affect uptime and revenue continuity

What market signals should investors and R&D leaders track for PYLARIFY TRUVU?

Commercial execution indicators

• Dispensing and administered utilization at contracted sites
• Backorder and stock-out events that delay scheduled imaging
• Coverage decisions and payer policy updates tied to labeling scope
• Hospital network adoption (share of sites using the agent in prostate imaging workflows)

Financial realization indicators

• Net price trends versus list price
• Contracting penetration across IDNs and GPO members
• Wastage rates and inventory turns at radiopharm and customer site levels

Strategic indicators

• Evidence generation that supports broader labeling or payer acceptance
• Competitive positioning in comparative clinical studies or real-world utilization

How do regulatory and manufacturing realities affect time-to-revenue?

Radiopharmaceuticals face higher operational cadence risk than standard small molecules:

• production scheduling tied to radioisotope supply chains
• regulated manufacturing capacity and batch release timing
• cold-chain logistics that constrain late substitution

These factors create a revenue profile where:

• initial growth can be constrained by production and distribution
• later growth becomes sensitive to operational uptime rather than marketing alone

What does the market outlook imply for financial performance directionally?

Upside drivers

• Expanded payer coverage and simplified prior authorization criteria
• Faster conversion from orders to administered studies through site adoption
• Contract wins with major hospital systems that increase procedure throughput

Downside risks

• Tightening coverage criteria that reduce eligible studies
• Supply interruptions that reduce administered volume and create switching
• Increased competitive pressure that forces pricing discipline through contracting

Bottom line

• The product’s financial trajectory should be evaluated as a function of access velocity (coverage and contracting) and operational reliability (supply continuity and conversion to administered imaging).

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Key Takeaways

• PYLARIFY TRUVU demand follows imaging procedure volume and the coverage-to-utilization funnel, not broad chronic disease prevalence.
• Financial trajectory in radiopharmaceuticals is dominated by payer policy, hospital contracting, and supply reliability.
• Growth prospects depend on coverage breadth and site adoption, while downside risks come from coverage tightening and supply disruption.
• Net revenue and margin are shaped more by contracting, wastage, and logistics than by list price.

FAQs

1. Is PYLARIFY TRUVU a chronic therapy product?
   No. It is a radiopharmaceutical imaging agent, so revenue tracks administered imaging studies.

2. What most directly converts payer coverage into sales?
   Conversion from orders to administered scans at contracted nuclear medicine sites, supported by reimbursement and operational capacity.

3. Does supply reliability materially affect revenue?
   Yes. In radiopharmaceuticals, stock availability and batch release timing directly constrain administered volume.

4. What contracting factors matter most for realized pricing?
   Hospital system and IDN contracting terms, including GPO and formulary access that determine net prices.

5. What should be monitored for signs of market expansion?
   Coverage policy updates, adoption across major networks, and consistent uptime without stock-outs that delay imaging.

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References

[1] FDA. “Drug Trials Snapshots: PYLARIFY TRUVU.” U.S. Food and Drug Administration. https://www.fda.gov/ (accessed 2026-05-02).
[2] FDA. “Drug Approval and Databases: PYLARIFY TRUVU.” U.S. Food and Drug Administration. https://www.fda.gov/ (accessed 2026-05-02).