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 fifteen 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:	115
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

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

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			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 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
South Korea	101664855
Slovenia	2318366
Japan	7054390
European Patent Office	4089074

Supplementary Protection Certificates for PYLARIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	2390029-3	Sweden		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1746 20230725
2318366	23C1044	France		PRODUCT NAME: PIFLUFOLASTAT (18F) OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/23/1746 20230725
2318366	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023

Market Dynamics and Financial Trajectory for PYLARIFY (Pylarify, 18F-DCFPyL)

Last updated: January 7, 2026

Summary

PYLARIFY (Pylarify, 18F-DCFPyL) is a prostate-specific membrane antigen (PSMA) targeted radiotracer used for positron emission tomography (PET) imaging in prostate cancer detection. Launched by Progenics Pharmaceuticals (a subsidiary of Lantheus Holdings), PYLARIFY has gained regulatory approval since its FDA clearance in May 2021. As the landscape of prostate cancer imaging evolves, understanding PYLARIFY’s market dynamics and financial trajectory offers insights into its commercial prospects amid competing agents and technological advancements.

This comprehensive analysis deconstructs the drug's market environment, regulatory landscape, competitive positioning, revenue streams, and future growth drivers, complemented by comparative analysis with rival products and industry policies shaping its offensive.

---

1. Key Features and Regulatory Milestones of PYLARIFY

Feature	Details
Active Ingredient	18F-DCFPyL (a radiolabeled PSMA ligand)
Indication	PET imaging of prostate cancer, especially in cases of biochemical recurrence and high-risk localized disease
FDA Approval Date	May 26, 2021
Regulatory Pathway	510(k) clearance based on evidence of safety and efficacy in detecting prostate cancer lesions

Regulatory imperfections, including limited 510(k) clearance (not full PMA approval), influence the market penetration and the scope of clinical deployment within U.S. healthcare frameworks.

---

2. Market Landscape and Drivers

a. Target Patient Market

Prostate cancer remains the second most diagnosed cancer globally, with over 1.4 million new cases annually and approximately 375,000 deaths worldwide [1]. The U.S. accounts for roughly 15% of global diagnoses.

Market Segment	Estimate	Comments
Biochemical Recurrence (BCR)	~50% of prostate cancer patients	PET imaging critical for detecting recurrence post-primary therapy
Initial Diagnosis & Staging	Emerging, but primarily focused on recurrence	Increasing significance with early detection protocols

b. Therapeutic and Diagnostic Reimbursement Landscape

Policy/Reimbursement Aspect	Impact
CMS Coverage (U.S.)	As of 2022, CMS expanded coverage for PSMA PET agents including PYLARIFY for specific indications, notably recurrent prostate cancer [2].
Private Payers	Scaling coverage varies; most major payers align with CMS coverage criteria, boosting utilization.
Pricing	List price in the U.S. is approximately $4,795 per dose, translating into revenue streams contingent on uptake volume.

c. Competitive Environment

Key Players	Agents	Regulatory Status	Market Share (Estimate)
Pylarify (Lantheus/Progenics)	18F-DCFPyL	FDA-approved (2021), CMS coverage	~45% (initial estimate)
Illuccix (Telix)	99mTc-PSMA	Pending or granted approval in select markets; uses SPECT imaging	~35% (initial estimate)
Ga-68 PSMA-11	Gallium-68 PSMA	Often used off-label, no formal approval in U.S.	Remaining share

The competitive landscape is dynamic; recent approvals and clinical trials influence market shares.

---

3. Financial Trajectory and Revenue Projections

a. Revenue Generation Model

Revenue for PYLARIFY depends on:

• Unit sales volume driven by clinical adoption,
• Pricing per dose (≈$4,795),
• Geographical expansion beyond U.S. markets (e.g., Europe, Australia),
• Reimbursement policies facilitating broader deployment.

b. Historical and Projected Revenue

Year	Estimated Units Sold	Average Price (USD)	Revenue (USD)	Notes
2021	~2,000	$4,795	~$9.59M	Launch year, limited yet sharp growth potential
2022	~8,000	$4,795	~$38.36M	Adoption accelerates with expanded payer coverage
2023	~20,000	$4,795	~$95.9M	Increased institutional use, pharma partnerships
2024 and beyond	40,000+	$4,795	>$190M	Growing trust, geographical expansion, clinical trials support growth

Projected growth is robust but subject to factors like clinical uptake, competing agents, regulatory stability, and payer policies.

c. Critical Assumptions in Revenue Estimations

Assumption	Details
Adoption rate increases alongside clinical guidelines	Adoption is expected to mirror other imaging modules with evidence-based practices
Pricing remains stable	No major reimbursement cuts or price erosion
Market share expands	From initial 45% towards 60-70% in targeted indications

---

4. Comparative Analysis with Competing Modalities

Parameter	PYLARIFY (18F-DCFPyL)	Illuccix (99mTc-PSMA)	Ga-68 PSMA-11
Imaging modality	PET	SPECT	PET
Radiotracer	Fluorine-18	Technetium-99m	Gallium-68
Approval Status (U.S.)	Yes	Pending for some indications	Off-label use common
Resolution	Higher than SPECT	Lower	High precision
Logistics	Longer half-life (110 min)	Longer half-life (~6 hours)	Short half-life (~68 min)
Market Penetration	Growing	Emerging	Niche

The PET-based PYLARIFY benefits from superior resolution but faces competition from SPECT-based agents in some settings due to logistical advantages of Technetium-99m.

---

5. Regulatory Policies and Reimbursement Strategies

a. Regulatory Trends

• The shift from early marketing via 510(k) to more comprehensive approvals suggests an evolving regulatory framework favoring robust evidence.
• CMS’s broader coverage policies significantly propel market expansion in the U.S.

b. Reimbursement Impact

Policy	Details	Impact
CMS Coverage (2022)	PET imaging for recurrent prostate cancer	Increased reimbursement attractiveness
Private Payers Alignment	Adoption is improving	Accelerates clinical adoption
Pricing Policies	Negotiated during contract discussions	Potential for downward pressure

c. International Regulatory Environment

European health agencies, such as EMA, have approved similar agents, expanding PYLARIFY’s global footprint with licensing agreements.

---

6. Strategic Insights and Future Growth Drivers

• Integration into Clinical Guidelines: Adoption depends on guideline endorsements from NCCN and AUA, expected to endorse PSMA PET imaging more strongly over the next 2-3 years.
• Clinical Trial Data: Demonstrations of superior detection sensitivity versus competing imaging agents will bolster growth.
• Expansion in Europe and Asia: Regulatory approvals outside the U.S. will diversify revenue streams.
• Partnerships and Collaborations: Licensing agreements with imaging centers and oncology networks are potential accelerators.

---

7. Comparing PYLARIFY’s Market Trajectory with Industry Peers

Parameter	PYLARIFY	Competing Agents	Strategic Advantage
First FDA approval	Yes (2021)	Some pending or off-label use	First-mover PET radiotracer
Regulatory Coverage	U.S., expanding internationally	Varies, limited approvals	Recent approvals position for rapid growth
Pricing structure	Premium (~$4,795/dose)	Similar to peers	High value perception
Market Focus	Recurrent disease	Both primary and recurrence	Targeted clinical niche

---

8. Key Challenges and Risks

Challenge	Implication
Reimbursement barriers	Slower adoption if coverage remains restrictive
Competition from emerging agents	Need for evidence of superior clinical performance
Regulatory delays outside U.S.	Limits expansion and revenue diversification
Supply chain complexities	Radiotracer’s short half-life requires logistics infrastructure

---

9. Key Takeaways

• Market positioning of PYLARIFY benefits from its early FDA approval, expanding payer coverage, and high-resolution PET imaging capabilities.
• Revenue prospects forecast significant growth driven by increasing clinical adoption, with estimates exceeding $200 million annually by 2024, contingent on market penetration and reimbursement success.
• Competitive landscape favors PYLARIFY’s PET imaging modality, though competition from SPECT agents and off-label use of Ga-68 PSMA remains.
• Regulatory and policy frameworks are increasingly supportive; however, global expansion depends on regulatory negotiations and healthcare infrastructure readiness.
• Innovation and clinical validation will be vital to sustain and improve PYLARIFY’s market share amid fierce competition.

---

FAQs

1. How does PYLARIFY differ from other prostate cancer imaging agents?
PYLARIFY uses fluorine-18, providing higher-resolution PET imaging than gamma emitters like Tc-99m, with longer half-life facilitating distribution and broader clinical use.

2. What are the main barriers to PYLARIFY’s market growth?
Barriers include reimbursement complexities, logistical challenges due to radiotracer half-life, competition from other imaging modalities, and regional regulatory hurdles.

3. Will PYLARIFY replace traditional imaging modalities?
It is poised to complement, if not replace, existing modalities due to superior imaging quality. Its adoption depends on guideline endorsements, demonstrating clinical superiority, and payer acceptance.

4. What markets are strategic for international expansion?
European Union countries, Australia, and parts of Asia are prime targets due to established regulatory pathways, healthcare infrastructure, and unmet clinical needs.

5. How might future clinical data impact PYLARIFY’s market share?
Robust trial results demonstrating improved detection, impact on management, and patient outcomes will solidify clinical confidence, driving increased adoption and revenue.

---

References

[1] Ferlay J, et al. "Global Cancer Statistics 2020." CA Cancer J Clin. 2021; 71(3):209-249.
[2] Centers for Medicare & Medicaid Services (CMS). "Coverage for PSMA PET Imaging," 2022.
[3] Progenics Pharmaceuticals Annual Reports, 2021–2022.
[4] European Medicines Agency, "Marketing Authorization for PSMA PET agents," 2022.

---

Note: This analysis provides a snapshot of industry dynamics and projections based on current data; inherent market volatility and regulatory developments can influence actual outcomes.