FLUCICLOVINE F-18 - Generic Drug Details

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

Fluciclovine f-18 is the generic ingredient in one branded drug marketed by Blue Earth and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluciclovine f-18 has thirty patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for FLUCICLOVINE F-18

International Patents:	30
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	41
Patent Applications:	169
What excipients (inactive ingredients) are in FLUCICLOVINE F-18?	FLUCICLOVINE F-18 excipients list
DailyMed Link:	FLUCICLOVINE F-18 at DailyMed

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

Constraining patent/regulatory exclusivity:

10,010,632

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 FLUCICLOVINE F-18

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 1
Alliance for Clinical Trials in Oncology	Phase 3
Blue Earth Diagnostics, Inc	Phase 4

See all FLUCICLOVINE F-18 clinical trials

Pharmacology for FLUCICLOVINE F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLUCICLOVINE F-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,716,868
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,967,077
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,124,079
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,933,147
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	11,980,674
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,953,112

Expired US Patents for FLUCICLOVINE F-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016	5,808,146

International Patents for FLUCICLOVINE F-18

Country	Patent Number	Title	Estimated Expiration
Israel	191184	ציקלובוטיל מותמר כתרכובת אב לתרכובות אורגנית המתויגת עם הלוגן רדיואקטיבי (Substituted cyclobutyl precursor compound for radioactive halogen-labeled organic compounds)
Spain	2663496
South Korea	101608755
Norway	20082877
Japan	5635225
New Zealand	568179	Cyclobutane derivative as a precursor compound of radioactive halogen labeled organic compound

FLUCICLOVINE F-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluciclovine F-18

Introduction

Fluciclovine F-18, marketed as Axumin, is a synthetic amino acid PET radiotracer approved by the U.S. Food and Drug Administration (FDA) for the detection of suspected recurrent prostate cancer. Here, we delve into the market dynamics and financial trajectory of this innovative diagnostic tool.

FDA Approval and Regulatory Environment

In May 2016, the FDA approved Fluciclovine F-18 for the clinical indication of suspected prostate cancer recurrence based on elevated PSA levels after prior treatment. This approval marked a significant milestone, as it provided a new diagnostic option for patients with biochemical relapse of prostate cancer[1][4].

Market Need and Target Population

Prostate cancer is one of the most common cancers among men, and the recurrence rate after initial treatment is a significant clinical concern. The market need for accurate and reliable diagnostic tools to detect recurrent prostate cancer is substantial. Fluciclovine F-18 targets this need by offering high sensitivity and specificity for detecting both local and distant disease, particularly in patients with biochemical failure[1][2].

Competitive Landscape

The diagnostic imaging market for prostate cancer includes various PET tracers such as 11C-choline and prostate-specific membrane antigen (PSMA) ligands. However, Fluciclovine F-18 has demonstrated unique advantages, including higher diagnostic performance for small nodal disease and a more favorable biodistribution profile compared to 11C-choline[4][5].

Comparison with Other Tracers

• 11C-Choline: While both tracers are effective, Fluciclovine F-18 shows negligible uptake in kidneys, bowel, and delayed urinary excretion, making it more favorable for evaluating prostate cancer in the abdomen and pelvis[5].
• PSMA Ligands: Preliminary data suggest that PSMA ligands may have higher diagnostic performance, but more conclusive studies are needed to compare them directly with Fluciclovine F-18[4].

Clinical Performance and Diagnostic Accuracy

Fluciclovine F-18 has shown impressive diagnostic accuracy in clinical trials. It demonstrates high positive predictive values (PPV) and negative predictive values (NPV) for lymph node disease, especially with increasing PSA levels. For example, a PSA level of >8.9 was associated with a PPV and NPV of 100% each[2].

Detection of Bone Metastases

While data on bone metastases are less extensive, studies indicate that Fluciclovine F-18 can accumulate in both osteolytic and osteoblastic lesions, providing valuable information for patients with suspected bone involvement[2].

Economic Impact and Reimbursement

The economic impact of Fluciclovine F-18 is significant due to its ability to change treatment management. It was approved for Medicare pass-through reimbursement effective January 2017, which has facilitated its adoption in clinical practice. Studies have shown that Fluciclovine F-18 PET/CT can detect additional findings that lead to major changes in management, thereby potentially reducing overall healthcare costs by avoiding unnecessary treatments[1][4].

Market Penetration and Adoption

Since its approval, Fluciclovine F-18 has seen increasing adoption in nuclear medicine practices. The drug's unique biodistribution and early imaging window have made it a preferred choice for detecting recurrent prostate cancer. The need for specialized handling and imaging protocols has led to the development of best-practice guidelines, further supporting its integration into clinical workflows[4].

Financial Performance

The financial performance of Fluciclovine F-18 is closely tied to its market penetration and reimbursement status. As a FDA-approved and Medicare-reimbursed product, it has generated significant revenue for Blue Earth Diagnostics, Inc., the manufacturer. The demand for accurate diagnostic tools in the growing prostate cancer market ensures a stable financial trajectory for this product.

Revenue Growth

While exact revenue figures are not publicly disclosed in the sources, the increasing adoption and clinical utility of Fluciclovine F-18 suggest a positive revenue growth trend. The drug's approval and reimbursement have created a favorable market environment, contributing to its financial success.

Future Outlook

The future outlook for Fluciclovine F-18 remains promising. Ongoing research and clinical trials are expected to further establish its role in the diagnostic workup of prostate cancer. Potential applications in other malignancies, such as breast and glioma, although beyond the current scope, could expand its market reach[1].

Emerging Trends

• Combination with Other Modalities: Future studies may explore the combination of Fluciclovine F-18 with other imaging modalities or biomarkers to enhance diagnostic accuracy.
• Expanding Indications: There is potential for Fluciclovine F-18 to be approved for additional indications, which could significantly broaden its market.

Key Takeaways

• FDA Approval: Fluciclovine F-18 was approved by the FDA in 2016 for suspected recurrent prostate cancer.
• Market Need: It addresses a significant clinical need for accurate diagnostic tools in prostate cancer recurrence.
• Competitive Advantage: It offers higher diagnostic performance and a more favorable biodistribution profile compared to some other tracers.
• Economic Impact: It has the potential to reduce healthcare costs by guiding more precise treatment decisions.
• Financial Performance: It has generated significant revenue and is expected to continue growing due to its clinical utility and reimbursement status.

FAQs

Q: What is Fluciclovine F-18 used for?

A: Fluciclovine F-18 is used for the detection of suspected recurrent prostate cancer based on elevated PSA levels after prior treatment.

Q: How does Fluciclovine F-18 compare to other PET tracers?

A: Fluciclovine F-18 has a more favorable biodistribution profile compared to 11C-choline and shows similar to slightly higher diagnostic performance compared to some other tracers.

Q: Is Fluciclovine F-18 reimbursed by Medicare?

A: Yes, Fluciclovine F-18 is approved for Medicare pass-through reimbursement.

Q: What are the key advantages of Fluciclovine F-18 in detecting prostate cancer?

A: It offers high sensitivity and specificity, particularly for small nodal disease, and has a favorable biodistribution profile that minimizes uptake in non-target tissues.

Q: Are there potential future applications for Fluciclovine F-18 beyond prostate cancer?

A: Yes, there is potential for its use in other malignancies such as breast and glioma, although these applications are currently under investigation.

Sources

1. Update on 18F-Fluciclovine PET for Prostate Cancer Imaging - Journal of Nuclear Medicine[1]
2. Pilot Study of F-18 Fluciclovine-PET/CT as a Diagnostic Tool for Prostate Cancer - Oxford Academic[2]
3. Regional distribution and kinetics of [18F]fluciclovine - PubMed[3]
4. Best Practices for 18F-Fluciclovine PET/CT Imaging of Recurrent Prostate Cancer - Journal of Nuclear Medicine Technology[4]
5. Imaging of Prostate Cancer Using Fluciclovine - Emory University School of Medicine[5]