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CERIANNA Drug Patent Profile

Which patents cover Cerianna, and what generic alternatives are available?

Cerianna is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in CERIANNA is fluoroestradiol f-18. One supplier is listed for this compound. Additional details are available on the fluoroestradiol f-18 profile page.

Summary for CERIANNA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	16
What excipients (inactive ingredients) are in CERIANNA?	CERIANNA excipients list
DailyMed Link:	CERIANNA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CERIANNA

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

212155

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.

Pharmacology for CERIANNA

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for CERIANNA

CERIANNA is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Ge Healthcare	CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155-001	May 20, 2020		RX	Yes	Yes

CERIANNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cerianna

Introduction

Cerianna (fluoroestradiol F 18) is a groundbreaking molecular imaging agent approved by the FDA for use in positron emission tomography (PET) imaging to detect estrogen receptor-positive lesions in patients with recurrent or metastatic breast cancer. Here, we delve into the market dynamics and financial trajectory surrounding this innovative drug.

Market Need and Indication

Cerianna is specifically indicated for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. This fills a critical gap in diagnostic capabilities, providing clinicians with previously unavailable data on the estrogen receptor status of tumors across the entire body[1][4][5].

Regulatory Approval and Distribution

The FDA approved Cerianna in 2020, marking it as the first F-18 PET imaging agent specifically for this indication. It is commercially available through PETNET Solutions, Inc., the exclusive U.S. commercial distributor, with additional manufacturing sites being added as they receive regulatory approval[1][4].

Market Size and Growth Potential

The theranostics market, which includes equipment, tracers, and therapies, is projected to grow significantly. Currently valued at about $9 billion, it is expected to reach $40 billion by 2032. This growth is driven by the increasing demand for diagnostic procedures and the expansion of novel therapies across various cancer types, including breast, ovarian, pancreatic, and lung cancers[2].

Financial Performance and Revenue Projections

GE HealthCare, a key player in the theranostics market, has seen significant growth in its pharmaceutical diagnostics segment. In 2023, this segment grew by 18% year-over-year and 23% in the fourth quarter, driven by global expansions in diagnostic procedures and the need for imaging agents like Cerianna[2].

Revenue Contribution

Cerianna is part of GE HealthCare's robust pipeline of diagnostic and therapeutic imaging solutions. The company's pharmaceutical diagnostics segment, which includes molecular imaging and cancer-targeting imaging tracers, generated $2.3 billion in revenue in 2023. This segment is expected to continue growing, driven by the increasing adoption of theranostic procedures[2].

Strategic Partnerships and Manufacturing

The partnership between PETNET Solutions, Inc., and Zionexa USA is crucial for the distribution and manufacturing of Cerianna. PETNET Solutions' extensive network of radiopharmacies enables widespread access to this cutting-edge radiotracer, helping healthcare facilities address the challenges of recurrent and metastatic breast cancer[4].

Competitive Landscape

The market for theranostics is highly competitive, with several companies investing heavily in research and development. GE HealthCare's strategy includes organic and inorganic expansions, such as the proposed acquisition of AI developer MIM Software, to enhance its imaging analysis capabilities and integrate them into its theranostics offerings[2].

Future Growth and Innovations

GE HealthCare plans to significantly increase its theranostics franchise over the next three years through a combination of organic and inorganic expansions. The company is launching more than 40 new products and has a robust pipeline of innovations, including Flurpiridaz for diagnosing and assessing coronary artery disease, which is expected to advance PET/CT imaging significantly[2].

Financial Impact on GE HealthCare

In its first year as an independent company, GE HealthCare posted an 8% boost in organic annual revenue, with total revenue reaching $19.6 billion. While the company expects a slightly lower growth rate of 4% in 2024, the pharmaceutical diagnostics segment remains a key growth driver. The company's investments in R&D and its robust pipeline of innovations are expected to continue driving revenue and market share gains[2].

Key Takeaways

• Market Need: Cerianna addresses a critical need for better diagnostic tools in recurrent and metastatic breast cancer.
• Regulatory Approval: FDA-approved in 2020, marking a significant milestone in theranostics.
• Distribution: Available through PETNET Solutions, Inc., with expanding manufacturing sites.
• Market Growth: Part of a theranostics market projected to grow to $40 billion by 2032.
• Financial Performance: Contributing to GE HealthCare's growing pharmaceutical diagnostics segment.
• Strategic Partnerships: Collaboration between PETNET Solutions and Zionexa USA is key to its success.
• Future Innovations: GE HealthCare's ongoing investments in R&D and new product launches.

FAQs

1. What is Cerianna used for? Cerianna is used in PET imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer[1][4].

2. Who are the key partners involved in the distribution of Cerianna? The key partners are PETNET Solutions, Inc., and Zionexa USA, with PETNET Solutions serving as the exclusive U.S. commercial distributor[1][4].

3. What is the projected growth of the theranostics market? The theranostics market is expected to grow from about $9 billion to $40 billion by 2032[2].

4. How does Cerianna fit into GE HealthCare's financial strategy? Cerianna is part of GE HealthCare's growing pharmaceutical diagnostics segment, which saw an 18% year-over-year growth in 2023 and is expected to continue driving revenue[2].

5. What are the future innovations and expansions planned by GE HealthCare in the theranostics segment? GE HealthCare plans to increase its theranostics franchise through organic and inorganic expansions, including new product launches and the integration of AI technologies[2].

Sources

1. Journal of Nuclear Medicine: Estrogen Receptor Agent Approved.
2. Fierce Biotech: GE HealthCare plots theranostics growth as it beats earnings estimates in first independent year.
3. GE HealthCare Investor Relations: Delivering precision care through innovation.
4. Siemens Healthineers Press Release: PETNET Solutions and Zionexa USA Announce FDA Approval of Cerianna.
5. Precision Medicine Online: GE Healthcare Educating Docs on Guidelines-Backed Use of Imaging Agent for ER-Positive Breast Cancer.