PIFLUFOLASTAT F-18 - Generic Drug Details

What are the generic sources for piflufolastat f-18 and what is the scope of freedom to operate?

Piflufolastat f-18 is the generic ingredient in one branded drug marketed by Progenics Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Piflufolastat f-18 has ninety-six patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for PIFLUFOLASTAT F-18

International Patents:	96
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	3
Patent Applications:	77
What excipients (inactive ingredients) are in PIFLUFOLASTAT F-18?	PIFLUFOLASTAT F-18 excipients list
DailyMed Link:	PIFLUFOLASTAT F-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PIFLUFOLASTAT F-18

Constraining patent/regulatory exclusivity:

8,778,305

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 PIFLUFOLASTAT F-18

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 PIFLUFOLASTAT F-18 clinical trials

Pharmacology for PIFLUFOLASTAT F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for PIFLUFOLASTAT F-18

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
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	9,861,713		Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	10,947,197		Y	Y
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	8,487,129		Y	Y
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 PIFLUFOLASTAT F-18

Country	Patent Number	Title	Estimated Expiration
Japan	2019521104	放射線標識した前立腺特異的膜抗原（ＰＳＭＡ）阻害剤 ［１８Ｆ］ＤＣＦＰｙＬ の改良合成
Finland	C20230033
Hungary	E026216
Croatia	P20220742
Slovenia	3222615
European Patent Office	2942065	HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID)

Supplementary Protection Certificates for PIFLUFOLASTAT F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	37/2023	Austria		PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 (MITTEILUNG) 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	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/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	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023

PIFLUFOLASTAT F-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Piflufolastat F-18

Introduction

Piflufolastat F-18, marketed under the brand names Pylarify in the US and Pyclari in the EU, is a groundbreaking radiopharmaceutical diagnostic agent used in positron emission tomography (PET) to detect prostate-specific membrane antigen (PSMA)-positive lesions in prostate cancer patients. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Regulatory Approvals and Market Expansion

FDA Approval in the US

Piflufolastat F-18 received FDA approval in May 2021, marking a significant milestone in the diagnosis and management of prostate cancer. This approval was based on data from the phase 3 OSPREY and CONDOR trials, which demonstrated the safety and efficacy of the agent[1][3].

EMA Approval in the EU

In July 2023, the European Medicines Agency (EMA) granted marketing authorization for piflufolastat F-18 under the brand name Pyclari. This approval has facilitated the drug's expansion into the European market, with initial commercial doses administered in several countries including Greece, Italy, the Netherlands, Germany, Austria, and France[1][3].

Market Expansion and Adoption

European Roll-Out

The European roll-out of piflufolastat F-18 is progressing rapidly. The first commercial doses have been administered in Austria and France, with production facilities established in multiple locations across these countries. This expansion is part of a broader strategy to make the diagnostic available in more European countries in 2024[1].

Clinical Indications

Piflufolastat F-18 is indicated for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy and for localizing recurrence of prostate cancer in patients with suspected recurrence based on increasing serum PSA levels. This targeted approach enhances diagnostic accuracy and guides more effective treatment strategies[1][3].

Financial Performance and Revenue Projections

Revenue Growth

The approval and subsequent market expansion of piflufolastat F-18 have contributed significantly to the revenue growth of its developers and distributors. For instance, Lantheus Holdings, Inc., which is involved in the commercialization of the drug, has seen an increase in revenues from its Pharma Services offering, including piflufolastat F-18[2].

Cost-Effectiveness

A key factor in the financial trajectory of piflufolastat F-18 is its cost-effectiveness. Studies have shown that piflufolastat F-18 is more cost-effective compared to other imaging modalities such as fluciclovine F-18, gallium68-PSMA-11, and standard of care (SOC) imaging. The incremental cost-effectiveness ratio (ICER) for piflufolastat F-18 is significantly lower, making it a financially viable option for healthcare systems[4].

Clinical Trials and Efficacy Data

OSPREY and CONDOR Trials

The OSPREY and CONDOR trials provided robust data on the safety and efficacy of piflufolastat F-18. These trials demonstrated high specificity and positive predictive value (PPV) in detecting PSMA-positive lesions, with a disease detection rate of 59% to 66%. The trials also showed that the use of piflufolastat F-18 led to a change in intended management in 63.9% of patients[1].

Adverse Events

Adverse events associated with piflufolastat F-18 were minimal, occurring in 2% or less of patients. Common adverse events included headache, dysgeusia, and fatigue, with one patient experiencing a delayed hypersensitivity reaction[1].

Market Competition and Differentiation

Competitive Landscape

Piflufolastat F-18 operates in a competitive landscape that includes other PSMA-targeted radiotracers. However, its superior diagnostic accuracy and cost-effectiveness have positioned it as a leading option. The drug's ability to detect lesions at low PSA levels and its high specificity and PPV differentiate it from competitors[1][4].

Market Penetration

The market penetration of piflufolastat F-18 is expected to increase as more healthcare providers adopt this diagnostic tool. The expansion into new markets and the establishment of production facilities in multiple countries will further enhance its availability and accessibility[1].

Financial Impact on Healthcare Systems

Cost Savings

The use of piflufolastat F-18 can lead to significant cost savings for healthcare systems. By providing more accurate diagnoses, it reduces the need for additional imaging tests and unnecessary treatments, thereby lowering overall healthcare costs[4].

Quality-Adjusted Life Years (QALYs)

Studies have shown that piflufolastat F-18 results in higher QALYs compared to other imaging modalities. This improvement in patient outcomes, combined with its cost-effectiveness, makes it a valuable asset for healthcare systems aiming to optimize resource allocation[4].

Future Outlook and Growth Potential

Continued Market Expansion

The future outlook for piflufolastat F-18 is promising, with plans for further market expansion in Europe and potentially other regions. As more countries approve the drug, its market reach and revenue potential are expected to grow[1].

Integration with Emerging Therapies

Piflufolastat F-18 is also being integrated into the development of PSMA-targeted therapies, further enhancing its market value. This integration could lead to new treatment paradigms and increased demand for the diagnostic agent[2].

Key Takeaways

• Regulatory Approvals: Piflufolastat F-18 has received FDA and EMA approvals, facilitating its market expansion.
• Market Expansion: The drug is being rolled out in multiple European countries, with plans for further expansion.
• Clinical Efficacy: It has demonstrated high specificity and PPV in clinical trials, leading to changes in patient management.
• Cost-Effectiveness: Piflufolastat F-18 is more cost-effective than other imaging modalities, offering significant financial benefits to healthcare systems.
• Future Outlook: The drug has strong growth potential with continued market expansion and integration into emerging therapies.

FAQs

Q: What is piflufolastat F-18 used for?

A: Piflufolastat F-18 is used for the detection of PSMA-positive lesions in prostate cancer patients, particularly for the primary staging and localization of recurrence.

Q: When was piflufolastat F-18 approved by the FDA?

A: Piflufolastat F-18 was approved by the FDA in May 2021 under the brand name Pylarify[1].

Q: How does piflufolastat F-18 compare to other imaging modalities in terms of cost-effectiveness?

A: Piflufolastat F-18 is more cost-effective compared to fluciclovine F-18, gallium68-PSMA-11, and standard of care (SOC) imaging, with lower ICERs[4].

Q: What are the common adverse events associated with piflufolastat F-18?

A: Common adverse events include headache, dysgeusia, and fatigue, occurring in 2% or less of patients[1].

Q: How does piflufolastat F-18 impact healthcare costs?

A: The use of piflufolastat F-18 can lead to significant cost savings by reducing the need for additional imaging tests and unnecessary treatments, thereby lowering overall healthcare costs[4].

Sources

1. European market for piflufolastat F 18 continues to expand. Urology Times.
2. United States Securities and Exchange Commission. Lantheus Holdings, Inc.
3. Piflufolastat F 18: Uses, Interactions, Mechanism of Action. DrugBank.
4. Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen .... PubMed.