FLUOROESTRADIOL F-18 - Generic Drug Details

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

Fluoroestradiol f-18 is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FLUOROESTRADIOL F-18

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	23
Patent Applications:	44
DailyMed Link:	FLUOROESTRADIOL F-18 at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 FLUOROESTRADIOL F-18

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

Sponsor	Phase
Peking Union Medical College Hospital	Phase 3
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
Abramson Cancer Center of the University of Pennsylvania	Early Phase 1

See all FLUOROESTRADIOL F-18 clinical trials

Pharmacology for FLUOROESTRADIOL F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

Anatomical Therapeutic Chemical (ATC) Classes for FLUOROESTRADIOL F-18

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FLUOROESTRADIOL F-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155-001	May 20, 2020		RX	Yes	Yes

FLUOROESTRADIOL F-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluoroestradiol F-18

Introduction

Fluoroestradiol F-18, also known as Cerianna, is a radiolabeled analog of estradiol used in positron emission tomography (PET) imaging to detect estrogen receptor-positive breast cancer lesions. This article delves into the market dynamics and financial trajectory of this innovative diagnostic agent.

Market Definition and Scope

The global fluorine-18 market, which includes Fluoroestradiol F-18, was valued at over US$ 1.5 billion in 2020 and is projected to expand at a CAGR of 7.5% from 2021 to 2031, reaching a valuation of over US$ 3 billion by 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the Fluoroestradiol F-18 market:

Increasing Prevalence of Breast Cancer

The rising incidence of breast cancer globally has increased the demand for precise diagnostic tools. Fluoroestradiol F-18, with its ability to detect estrogen receptor-positive lesions, is a valuable asset in this context[2][3].

Advancements in PET Imaging

The advancement in PET imaging technology and the increasing preference for non-invasive diagnostic methods are significant drivers. PET-CT scans, particularly those using Fluoroestradiol F-18, offer more accurate and detailed information about tumor progression and response to treatment[1][3].

Regulatory Approvals

The FDA approval of Fluoroestradiol F-18 in May 2020 marked a significant milestone, paving the way for its widespread adoption in clinical settings. This approval has been crucial in expanding its market reach[2][4].

Market Segmentation

The market for Fluoroestradiol F-18 can be segmented based on product, end-user, and region.

Product Segmentation

The primary product segment for Fluoroestradiol F-18 is its use as a diagnostic agent for PET imaging. It is specifically indicated for detecting estrogen receptor-positive lesions in patients with recurrent or metastatic breast cancer[2][4].

End-User Segmentation

The key end-users include hospitals, diagnostic centers, and other healthcare facilities. The increasing demand from these sectors, particularly in developed countries, is driving market growth[1].

Regional Segmentation

Asia Pacific countries, such as India and China, are emerging as significant markets due to the rising demand for advanced diagnostic tools. North America and Europe also remain key regions, driven by high healthcare standards and advanced infrastructure[1].

Financial Trajectory

The financial trajectory of Fluoroestradiol F-18 is promising, driven by several economic and clinical factors:

Cost-Effectiveness

Studies have shown that adding Fluoroestradiol F-18 PET/CT to biopsy and immunohistochemistry (IHC) can be cost-effective. It reduces the need for re-biopsies and provides more accurate diagnostic results, leading to significant cost savings. For instance, a study estimated cost savings of up to $142 million by reducing the need for re-biopsies and improving diagnostic accuracy[5].

Market Expansion

The market expansion is also driven by the strategic partnerships and distribution networks. For example, PETNET Solutions, Inc. and Zionexa USA are collaborating to ensure timely regional manufacturing and distribution of Fluoroestradiol F-18 across the United States[4].

Revenue Projections

Given the increasing demand and the cost-effectiveness of Fluoroestradiol F-18, the revenue projections are optimistic. The global fluorine-18 market, which includes this product, is expected to grow significantly over the next decade, driven by the increasing adoption of PET-CT imaging in healthcare[1].

Challenges and Limitations

Despite the positive outlook, there are several challenges and limitations:

High Setup Costs

The cost of installing PET/CT scan facilities with cyclotrons is high, ranging from US$ 5 million to US$ 6 million. This can be a barrier for smaller healthcare facilities and developing regions[1].

Availability and Distribution

The half-life of Fluoroestradiol F-18 is 110 minutes, which necessitates timely and efficient distribution. This can be a logistical challenge, especially in regions with limited infrastructure[4].

Industry Expert Insights

Industry experts emphasize the potential of Fluoroestradiol F-18 in improving patient outcomes. For example, Webner from Zionexa USA highlights that "with FES-PET, we can identify patients who have estrogen-driven disease versus those who don’t, or those who have mixed disease. This actionable data helps clinicians make therapeutic choices that can extend patient survival and improve outcomes"[4].

Clinical Applications and Future Potential

The clinical applications of Fluoroestradiol F-18 are vast and include:

Detection of ER-Positive Lesions

It is used as an adjunct to biopsy in patients with recurrent or metastatic breast cancer to detect estrogen receptor-positive lesions. This helps in assessing tumor progression and response to treatment[2][3].

Assessing ER Expression

Fluoroestradiol F-18 PET can quantify in vivo ER expression, which is crucial for predicting the response to endocrine therapies. This can help in personalizing treatment plans and improving patient outcomes[3].

Key Takeaways

• Market Growth: The global fluorine-18 market, including Fluoroestradiol F-18, is projected to grow at a CAGR of 7.5% from 2021 to 2031.
• Cost-Effectiveness: Adding Fluoroestradiol F-18 PET/CT to biopsy and IHC can be cost-effective, reducing the need for re-biopsies and improving diagnostic accuracy.
• Clinical Applications: It is used for detecting estrogen receptor-positive lesions and assessing ER expression, which is crucial for personalized treatment plans.
• Challenges: High setup costs and logistical challenges in distribution are significant barriers.

FAQs

Q: What is Fluoroestradiol F-18 used for? A: Fluoroestradiol F-18 is used as a diagnostic agent in PET imaging to detect estrogen receptor-positive breast cancer lesions.

Q: What is the FDA status of Fluoroestradiol F-18? A: Fluoroestradiol F-18 was approved by the FDA in May 2020 for use in PET imaging for the detection of estrogen receptor-positive lesions in patients with recurrent or metastatic breast cancer.

Q: How does Fluoroestradiol F-18 improve diagnostic accuracy? A: It provides high diagnostic accuracy by quantifying in vivo ER expression and identifying estrogen receptor-positive lesions without the need for multiple biopsies.

Q: What are the cost implications of using Fluoroestradiol F-18? A: Studies have shown that using Fluoroestradiol F-18 PET/CT can be cost-effective by reducing the need for re-biopsies and improving diagnostic accuracy, leading to significant cost savings.

Q: Who are the key players in the Fluoroestradiol F-18 market? A: Key players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company).

Cited Sources

1. Transparency Market Research: Fluorine-18 Market Insight and Trends 2031.
2. DrugBank: Fluoroestradiol F-18: Uses, Interactions, Mechanism of Action.
3. PubMed: 18F-Fluoroestradiol PET: Current Status and Potential.
4. Siemens Healthineers: Fluoroestradiol F 18 - Siemens Healthineers USA.
5. PLOS ONE: Clinical and economic outcomes of adding [18F]FES PET/CT to biopsy/IHC in the determination of ER-positive status in metastatic and recurrent breast cancer.