Last updated: September 6, 2026
Piflufolastat F-18, marketed as Pylarify by Lantheus Holdings, is one of the leading prostate-specific membrane antigen, or PSMA, positron-emission tomography agents in the United States. FDA approval in 2021 created a large commercial market for molecular imaging in prostate cancer staging and recurrence detection. Pylarify revenue expanded rapidly after launch, supported by high PSMA-PET adoption, Medicare coverage, expanded imaging capacity and Lantheus’s national commercial infrastructure.
The principal risks are competition from other PSMA radiotracers, dependence on nuclear-medicine production and distribution, reimbursement pressure, hospital capital constraints and the eventual erosion of exclusivity. Pylarify has no biosimilar risk because it is a small-molecule radiopharmaceutical, but competing diagnostic agents can take share without being legally classified as generics.
What is piflufolastat F-18 and how is Pylarify used?
Piflufolastat F-18 is a fluorine-18-labeled PSMA-targeting diagnostic agent. It binds to PSMA-expressing prostate cancer cells and permits PET imaging of suspected or confirmed prostate cancer lesions.
The FDA-approved indications cover two major uses:
- Initial staging in patients with unfavorable intermediate-risk, high-risk or very-high-risk prostate cancer.
- Localization of suspected recurrence based on elevated prostate-specific antigen levels after prior treatment. [1]
Pylarify is administered intravenously and imaged by PET. Fluorine-18 has a physical half-life of approximately 110 minutes, which requires coordinated manufacturing, quality release, shipment and administration. The short half-life limits conventional inventory models and makes production-site density a material competitive factor. [1]
Product profile
| Attribute |
Piflufolastat F-18 |
| Brand |
Pylarify |
| Active diagnostic agent |
Piflufolastat F-18 |
| Imaging modality |
PET |
| Molecular target |
PSMA |
| FDA approval |
May 27, 2021 |
| Primary manufacturer and marketer |
Lantheus Holdings |
| Main disease area |
Prostate cancer |
| Key uses |
Initial staging and suspected recurrence |
| Radioisotope |
Fluorine-18 |
| Physical half-life |
Approximately 110 minutes |
| Biosimilar exposure |
None |
| Main competitive risk |
Competing PSMA PET agents and alternative prostate-cancer imaging |
How large is the piflufolastat F-18 market?
The addressable market is driven by the number of men diagnosed with clinically significant prostate cancer, the volume of biochemical-recurrence evaluations and the rate at which urologists, radiation oncologists and medical oncologists adopt PSMA PET instead of conventional imaging.
PSMA PET has expanded the diagnostic pathway beyond a narrow specialist market. It can alter radiation fields, identify metastatic disease, avoid inappropriate local treatment and guide subsequent management. Those clinical effects support repeat utilization as patients move through diagnosis, treatment and recurrence monitoring.
The market remains concentrated in the United States because Pylarify’s commercial penetration and reimbursement infrastructure are strongest there. International growth depends on local regulatory approvals, radiopharmaceutical production capacity, reimbursement and the ability to deliver the product within its short usable window.
Key demand drivers
- Rising prostate cancer incidence and a large survivor population.
- Increased use of imaging at biochemical recurrence.
- Greater clinical acceptance of PSMA PET over older imaging approaches.
- Expanded PET scanner access and radiopharmaceutical distribution.
- Medicare and commercial reimbursement for clinically appropriate PSMA PET procedures.
- Use of imaging results to direct surgery, radiation and systemic therapy.
- Increasing integration of nuclear medicine into community oncology networks.
Market constraints
- Limited PET scanner capacity in some community settings.
- Radioisotope production and delivery requirements.
- Reimbursement variation across payers.
- Hospital scheduling and radiopharmacy logistics.
- Competition from gallium-68 and other fluorine-18 PSMA products.
- Potential pricing pressure as multiple PSMA agents become available.
What has been Pylarify’s financial trajectory?
Pylarify moved from launch-stage revenue to a major commercial product for Lantheus within two years. Lantheus reported Pylarify net product revenue of approximately $755.6 million in 2023, compared with approximately $501.2 million in 2022. The increase reflected broader clinical adoption, higher scan volumes and continued expansion of the company’s distribution network. [2]
Lantheus reported total revenue of approximately $1.31 billion in 2023. Pylarify therefore represented roughly 58% of company revenue on the reported figures, making it the company’s largest individual growth product and a central driver of operating leverage. [2]
| Fiscal year |
Pylarify net product revenue |
Approximate change |
Commercial interpretation |
| 2021 |
Launch-stage revenue |
Not comparable |
FDA approval and initial commercialization |
| 2022 |
Approximately $501 million |
Strong expansion |
National adoption accelerated |
| 2023 |
Approximately $756 million |
Approximately 51% |
Pylarify became Lantheus’s principal revenue engine |
| 2024 and later |
Continued growth expected, subject to competition |
Dependent on scan growth and share |
Maturation of PSMA PET market becomes more important |
Lantheus’s growth profile is more complicated than a single-product launch story. The company also sells Definity, an ultrasound contrast agent, and other diagnostic products. However, Pylarify materially changed the company’s revenue mix and raised the importance of reimbursement, radiopharmaceutical manufacturing and oncology-market execution.
What supports future revenue growth?
Pylarify’s future revenue depends mainly on scan volume rather than prescription refills. The principal growth variables are:
- The percentage of eligible prostate cancer patients receiving PSMA PET.
- Expansion from academic centers into community imaging sites.
- Increased use in recurrent disease.
- Referral patterns from urologists and radiation oncologists.
- Medicare and commercial payer coverage.
- Supply reliability across the national distribution network.
- The ability to retain sites after competing PSMA agents are introduced.
Revenue growth should decelerate as the U.S. market moves from early adoption toward broader penetration. At that stage, share retention, reimbursement and service quality become more important than simple market creation.
How does Pylarify compare with competing prostate cancer imaging agents?
Pylarify competes principally with Illuccix, Posluma and Axumin.
| Product |
Active agent |
Isotope |
Company |
FDA status |
Competitive position |
| Pylarify |
Piflufolastat F-18 |
F-18 |
Lantheus |
Approved 2021 |
Strong U.S. commercial scale and fluorine-18 logistics |
| Illuccix |
Piflufolastat? No, gallium-68 gozetotide |
Ga-68 |
Telix |
Approved 2021 |
Established PSMA PET competitor |
| Posluma |
Flotufolastat F-18 |
F-18 |
Blue Earth Diagnostics, Bracco |
Approved 2023 |
Direct fluorine-18 PSMA competitor |
| Axumin |
Fluciclovine F-18 |
F-18 |
Blue Earth Diagnostics |
Approved 2016 |
Non-PSMA recurrence-imaging alternative |
The principal technical comparison is between fluorine-18 and gallium-68. Fluorine-18 has a longer half-life and can support broader regional distribution from centralized production sites. Gallium-68 can be produced through generators or local radiopharmacy systems, although supply and operational models differ by site.
Posluma creates the most direct product-level competition because it is also an F-18 PSMA PET agent. Clinical performance, availability, payer coverage, site contracts and physician familiarity may matter more than label differences in many purchasing decisions. [3][4]
What is the FDA regulatory and reimbursement status of Pylarify?
The FDA approved Pylarify as a diagnostic radiopharmaceutical for PSMA PET imaging in prostate cancer. The approval was based on data supporting lesion localization in initial staging and suspected recurrence. [1]
The product is billed as a radiopharmaceutical used with PET imaging. Medicare reimbursement generally involves separate payment mechanics for the imaging procedure and the radiopharmaceutical, subject to applicable coding, site-of-care rules and medical-necessity requirements. CMS policies and annual payment schedules affect provider economics. [5]
Commercial uptake depends on more than FDA approval. Imaging centers must have PET capacity, trained personnel, radiopharmacy access, payer contracts and scheduling systems capable of handling a short-lived product. A product with broad regulatory approval can still encounter local adoption barriers if delivery timing or reimbursement is unfavorable.
What patents and exclusivity protect piflufolastat F-18?
Pylarify’s protection is based on a combination of patent rights, regulatory exclusivity, proprietary know-how, manufacturing controls, radiopharmacy logistics and commercial scale.
The relevant intellectual-property categories include:
- PSMA-targeting ligand and compound claims.
- Radiolabeled compound claims covering fluorine-18 products.
- Precursor and labeling-process claims.
- Formulation and kit-related claims.
- Manufacturing and quality-control methods.
- Use claims for prostate cancer imaging.
- Trade secrets involving production, release testing and distribution.
Unlike a conventional oral drug, Pylarify’s competitive protection is not limited to a single tablet formulation or an active pharmaceutical ingredient. Manufacturing consistency, regulatory compliance and delivery within the isotope’s usable window can create practical barriers to entry.
Orange Book status and Paragraph IV exposure
Piflufolastat F-18 is a diagnostic radiopharmaceutical rather than a conventional therapeutic drug. Its exclusivity analysis therefore requires review of FDA patent listings, approved-label protections, applicable patent-term adjustments and any court or settlement records. A standard small-molecule generic-launch analysis does not fully describe the competitive pathway.
Publicly visible market risk is more likely to arise from competing PSMA radiotracers than from an Abbreviated New Drug Application that is therapeutically substitutable in the conventional generic sense. A competitor can win business by obtaining its own FDA approval and reimbursement, without proving that it is the same product as Pylarify.
No material biosimilar risk applies. Biosimilar pathways concern biological products, while piflufolastat F-18 is a radiolabeled small-molecule diagnostic agent.
What patent litigation and licensing issues affect the market?
The principal legal issues are likely to involve:
- Ownership and scope of PSMA ligand patents.
- Patent validity and enforceability.
- Radiolabeling and precursor claims.
- Manufacturing-process rights.
- Commercial licenses originating from the Progenics technology portfolio.
- Contractual rights connected to radiopharmaceutical production and distribution.
Lantheus obtained the Pylarify commercial opportunity through its acquisition of Progenics. The transaction gave Lantheus control of Progenics’s prostate-cancer imaging technology and related pipeline assets. [6]
Public market competition has not been defined primarily by a major generic Paragraph IV litigation wave. It has been defined by parallel FDA approvals of PSMA imaging agents, commercial contracting and manufacturing scale. The absence of conventional generic litigation does not eliminate IP risk. It shifts the risk toward patent scope, technology licensing and the ability of competitors to develop non-infringing PSMA ligands.
How strong is the Pylarify commercial and patent estate?
Pylarify has a strong commercial position but a more nuanced long-term exclusivity profile.
Commercial strengths
- Early entry into the U.S. PSMA PET market.
- High brand recognition among prostate cancer specialists.
- Lantheus’s established diagnostic sales organization.
- A national radiopharmaceutical distribution model.
- Fluorine-18 characteristics that support centralized production and regional shipment.
- Large installed base of imaging centers.
- Significant revenue scale that can support manufacturing and market access investment.
Commercial weaknesses
- Dependence on time-sensitive production and delivery.
- Exposure to competing PSMA products.
- Concentrated reliance on the U.S. market.
- Reimbursement sensitivity.
- Potential physician and payer preference for different isotopes or suppliers.
- Product revenue concentration within Lantheus.
Patent and regulatory strengths
- Multiple possible protection layers around ligand, radiolabeling and manufacturing technology.
- FDA-approved indications with established clinical utility.
- Operational know-how that is difficult to replicate immediately.
- Regulatory and quality systems built around a commercial radiopharmaceutical.
Patent and regulatory weaknesses
- Competing PSMA ligands can avoid direct product identity.
- Method-of-use claims may not prevent all alternative imaging products.
- Short isotope half-life limits geographic flexibility.
- Patent expiry is less decisive than in a traditional chronic therapy if competitors have independent products.
- Clinical differentiation may be modest if physicians view products as interchangeable for routine PSMA PET.
What generic launch scenarios and competitive risks exist?
A conventional generic launch would be less important than a branded competitor launch. The realistic scenarios are:
| Scenario |
Market effect |
Likely timing driver |
| Slow competitor adoption |
Pylarify retains high share |
Strong site contracts and physician familiarity |
| Broad Posluma expansion |
Share and price pressure |
Manufacturing scale and payer access |
| Greater Illuccix penetration |
Regional share shifts |
Local generator access and radiopharmacy preference |
| Reimbursement tightening |
Lower net revenue per scan |
CMS and commercial payer policy |
| PSMA PET standardization |
Larger total market |
Higher utilization across recurrence and staging |
| Production disruption |
Immediate lost scans |
Isotope supply, release or transportation failure |
| New theranostic integration |
Potential demand growth |
Imaging used to select patients for PSMA-targeted therapy |
The highest-probability long-term risk is gradual share dilution rather than an abrupt loss of exclusivity. The market can expand while Pylarify’s percentage share declines.
Which companies are challenging Pylarify?
The main commercial challengers are Telix and Bracco’s Blue Earth Diagnostics.
Telix’s Illuccix competes with a gallium-68 PSMA product. Blue Earth Diagnostics, part of Bracco, markets Axumin and has introduced Posluma, a direct F-18 PSMA competitor. [3][4]
Competition also comes from imaging centers’ internal radiopharmacy decisions. A hospital may select an agent based on delivery reliability, generator ownership, scheduling flexibility, reimbursement, patient throughput or relationships with radiopharmacy suppliers.
What is the geographic coverage of piflufolastat F-18?
The strongest commercial coverage is in the United States. International expansion is constrained by:
- Country-specific regulatory review.
- Local radiopharmaceutical manufacturing.
- Distribution distance and isotope decay.
- Reimbursement negotiations.
- PET scanner density.
- Local treatment guidelines.
- Competition from locally produced gallium-68 agents.
Fluorine-18 can support centralized manufacturing, but the usable window remains short. Geographic expansion therefore requires a production network or reliable access to nearby cyclotron capacity.
What is the revenue exposure for Lantheus?
Pylarify is strategically important because it contributes a large share of Lantheus revenue and has higher growth visibility than mature diagnostic products. The product’s contribution affects:
- Consolidated revenue growth.
- Gross-margin mix.
- Sales-force productivity.
- Manufacturing investment.
- Investor valuation of Lantheus.
- Acquisition capacity and business-development strategy.
The company’s risk profile has therefore shifted from diversified diagnostic growth toward greater dependence on the durability of PSMA PET demand. Continued scan-volume growth can offset price and share pressure. A plateau in U.S. utilization would make competitive displacement more visible in reported results.
Key Takeaways
- Piflufolastat F-18, marketed as Pylarify, is a leading U.S. PSMA PET diagnostic for prostate cancer.
- FDA approval occurred on May 27, 2021, for initial staging and suspected recurrence.
- Pylarify revenue grew from approximately $501 million in 2022 to approximately $756 million in 2023.
- The product represented roughly 58% of Lantheus’s 2023 revenue on reported figures.
- Growth depends on PSMA PET adoption, imaging capacity, reimbursement and scan volume.
- Posluma is the most direct F-18 competitor; Illuccix is the principal gallium-68 competitor.
- Biosimilar risk is not relevant, and conventional generic substitution is less likely to define the market.
- The main long-term risk is share erosion from competing PSMA radiotracers, not necessarily a single patent-expiry event.
- Manufacturing, isotope supply, release testing and delivery logistics are material barriers to entry.
- Lantheus’s financial trajectory remains highly exposed to Pylarify’s market share and the continued expansion of prostate-cancer PSMA PET imaging.
FAQs
Is piflufolastat F-18 the same as Pylarify?
Yes. Pylarify is the commercial brand for piflufolastat F-18, an F-18-labeled PSMA PET imaging agent marketed by Lantheus.
Is Pylarify a prostate cancer treatment?
No. Pylarify is a diagnostic imaging agent. It helps identify and localize PSMA-expressing prostate cancer lesions but does not treat the disease.
Does Pylarify have biosimilar competition?
No. Biosimilar regulation applies to biological products. Pylarify is a radiolabeled small-molecule diagnostic agent.
Is Posluma a generic version of Pylarify?
No. Posluma contains a different PSMA-targeting compound and is an independently approved F-18 PET diagnostic. It competes commercially but is not a generic version of Pylarify.
Why is fluorine-18 distribution important to Pylarify’s business?
Fluorine-18 decays rapidly, with a half-life of about 110 minutes. Production, regulatory release and delivery must be coordinated closely, making radiopharmacy scale and logistics central to market access.
References
- U.S. Food and Drug Administration. (2021). Pylarify (piflufolastat F 18) prescribing information.
- Lantheus Holdings, Inc. (2024). Annual report on Form 10-K for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.
- U.S. Food and Drug Administration. (2021). Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information.
- U.S. Food and Drug Administration. (2023). Posluma (flotufolastat F 18) prescribing information.
- Centers for Medicare & Medicaid Services. (2024). Hospital outpatient prospective payment system and ambulatory surgical center payment system.
- Lantheus Holdings, Inc. (2020). Lantheus completes merger with Progenics Pharmaceuticals. Company transaction announcement.
