PYLARIFY Drug Patent Profile

When do Pylarify patents expire, and when can generic versions of Pylarify launch?

Pylarify is a drug marketed by Progenics Pharms Inc and Aphelion and is included in two NDAs. There are six patents protecting this drug.

This drug has one hundred and eighteen patent family members in twenty-seven countries.

The generic ingredient in PYLARIFY is piflufolastat f-18. Two suppliers are 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 November 7, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PYLARIFY

International Patents:	118
US Patents:	6
Applicants:	2
NDAs:	2

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 8,487,129.

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
Aphelion	PYLARIFY TRUVU	piflufolastat f-18	SOLUTION;INTRAVENOUS	220089-001	Mar 6, 2026		RX	Yes	Yes	8,778,305		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

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Poland

Portugal

Slovenia

Spain

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3026889
Canada	3240630
China	109563038
China	122187723

Supplementary Protection Certificates for PYLARIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	LUC00323	Luxembourg		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND 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	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	PA2023534	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724

Investment Scenario and Fundamentals Analysis for PYLARIFY (Pafolacianine)

Last updated: February 21, 2026

Summary:
PYLARIFY (pafolacianine) is a targeted optical imaging agent developed by On Target Laboratories, designed to enhance the detection of ovarian and lung cancers during surgery. Its FDA approval in October 2021 enables it to gain market traction. The investment outlook hinges on market adoption, competitive positioning, reimbursement strategies, and pipeline developments. The company’s financials remain modest, but potential growth depends on successful commercialization and expandability.

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What is PYLARIFY and its Approval Status?

PYLARIFY is a fluorescent imaging agent activated in folate receptor-alpha positive tumors. It improves intraoperative visualization, aiding surgeons in tumor resection. Its FDA approval on October 15, 2021, marks it as the first folate receptor-targeted imaging agent globally.

Regulatory Milestones:

Date	Event	Details
October 15, 2021	FDA Approval	Based on pivotal Phase 3 trial data (NCT02922998) showing improved detection of ovarian cancer per-patient sensitivity of 96% compared to 7% in standard visual inspection.
September 2022	CE Mark	Secured for European market access.

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Market Potential and Commercialization Challenges

Addressable Markets:

• Ovarian Cancer: Estimated 19,880 new cases in 2023 in the U.S. (American Cancer Society) with high unmet needs in surgical margin detection.
• Lung Cancer: Approximately 235,760 new cases in 2023 (SEER database); similar imaging challenges exist.

Market Penetration Factors:

• Reimbursement Pathway: Medicare and private insurance coverage is in early development stages; no established reimbursement codes currently.
• Physician Adoption: Adoption requires training and demonstration of clinical benefits; surgeons rely on FDA approval and peer-reviewed validation.
• Pricing Strategy: Expected premium pricing than standard imaging dyes due to targeted benefit, potentially in the $500–$1,000 range per procedure.

Competitive Landscape:

Competitor	Product	Approval	Differentiator
Novartis	VisionGuard	Phase 2/3	Fluorophore with broader tumor targeting
CytomX	CX-01	Phase 2	Tumor-specific antibody conjugated agents

Challenges:

• Limited existing clinical adoption post-approval.
• Reimbursement negotiations are ongoing.
• Potential competition from other imaging agents, especially those with broader or multimodal capabilities.

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Financial and Developmental Fundamentals

Revenue Projections:

Year	Estimates	Assumptions
2023	~$5 million	Early sales, limited footprint, initial uptake in ovarian indications
2025	~$50–$100 million	Expanded use in lung surgeries; broader clinician adoption
2030	>$300 million	Market penetration, expanded indications, potential new tumor types

Expenses:

• R&D: Focused on expanding pipeline targeting other cancers and improving imaging technology.
• Commercial Expenses: Marketing, sales force expansion, physician education.
• Regulatory & Legal: Ongoing planning for reimbursement and international approval.

Key Drivers:

• Adoption rate of PYLARIFY in surgical oncology.
• Reimbursement policies aligning with hospital and surgeon incentives.
• Clinical data supporting expanded indications and off-label use.

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Pipeline and Strategic Outlook

• Expansion into other tumor types: Preliminary data suggest potential in breast and pancreatic cancers.
• Combination therapies: Developing synergistic use with therapeutics or other imaging modalities.
• Global regulatory progress: Expected CE mark expansion and potential approvals in Asia-Pacific jurisdictions.

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Key Risks

• Slow or limited market adoption.
• Reimbursement hurdles delaying widespread uptake.
• Competitive entry or technological advances by rivals.
• Regulatory delays or post-market safety concerns.

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Investment Summary

PYLARIFY remains a promising, niche imaging agent with cleared regulatory pathway and demonstrated clinical efficacy. The primary value driver is market adoption aligned with reimbursement and clinical utility. Near-term growth depends heavily on establishing payer coverage, expanding indications, and demonstrating real-world benefits. Long-term upside hinges on pipeline expansion and international regulatory success.

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Key Takeaways:

• PYLARIFY is FDA-approved for intraoperative tumor detection in ovarian cancer, with initial commercialization underway.
• Market opportunity centers around ovarian and lung cancers; driving growth involves clinician adoption and reimbursement.
• Financial growth prospects are tied to market penetration, pricing, and pipeline expansion.
• Risks include market barriers, competition, and regulatory delays.
• Strategic expansion and international approvals could amplify long-term value.

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FAQs

1. What is the primary clinical advantage of PYLARIFY?
It enhances visualization of folate receptor-positive tumors during surgery, potentially reducing residual tumor rates.

2. How does PYLARIFY compare with traditional imaging dyes?
It offers targeted imaging with higher specificity for certain tumor types, unlike broad-spectrum dyes.

3. What reimbursement challenges could impact commercialization?
Lack of established billing codes and payer coverage could delay revenue growth.

4. Which indications are most commercially promising for PYLARIFY?
Ovarian cancer in surgical settings currently offers the most immediate market, with lung cancer following.

5. What are the main competitors?
Cancer Imaging Agents from Novartis and CytomX, with potential future competitors emerging from other biotech firms.

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References

1. American Cancer Society. (2023). Cancer facts & figures 2023.
2. U.S. Food and Drug Administration. (2021). PYLARIFY approval letter.
3. ClinicalTrials.gov. (2022). PYLARIFY pivotal trial data (NCT02922998).
4. European Medicines Agency. (2022). CE Mark approval documentation.