CHOLINE C-11 - Generic Drug Details

What are the generic drug sources for choline c-11 and what is the scope of freedom to operate?

Choline c-11 is the generic ingredient in one branded drug marketed by Decatur, Mcprf, Ucsf Rodiopharm, Univ Tx Md Anderson, and Wa Univ Sch Med, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for CHOLINE C-11

US Patents:	0
Tradenames:	1
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	166
Patent Applications:	10
What excipients (inactive ingredients) are in CHOLINE C-11?	CHOLINE C-11 excipients list
DailyMed Link:	CHOLINE C-11 at DailyMed

Recent Clinical Trials for CHOLINE C-11

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

Sponsor	Phase
Washington University School of Medicine	N/A
Balchem Corporation	N/A
Project Peanut Butter	N/A

See all CHOLINE C-11 clinical trials

Pharmacology for CHOLINE C-11

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for CHOLINE C-11

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mcprf	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	203155-001	Sep 12, 2012	AP	RX	Yes	Yes
Ucsf Rodiopharm	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	208444-001	Nov 20, 2017		DISCN	No	No
Decatur	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	206319-001	Nov 13, 2015	AP	RX	No	No
Wa Univ Sch Med	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	208413-001	Jan 10, 2017		DISCN	No	No
Univ Tx Md Anderson	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	205690-001	Oct 29, 2015		DISCN	No	No

CHOLINE C-11 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Choline C-11

Introduction

Choline C-11, a radiolabeled analog of choline, is a crucial diagnostic agent in positron emission tomography (PET) imaging, particularly for detecting recurrent prostate cancer. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its clinical significance, market demand, and the economic factors influencing its development and use.

Clinical Significance and Indications

Choline C-11 is indicated for PET imaging in patients with suspected prostate cancer recurrence, especially when other imaging modalities like bone scintigraphy, CT, or MRI are non-informative. Its ability to identify potential sites of prostate cancer recurrence is based on the elevated uptake of choline in tumor cells, which is associated with increased phospholipid synthesis and cell proliferation[4].

Market Demand

The demand for Choline C-11 is driven by the high incidence of prostate cancer recurrence. Approximately 90,000 men annually seek treatment for recurrent prostate cancer in the United States alone[5]. This significant patient population creates a substantial market for diagnostic tools that can accurately detect and localize recurrent cancer.

Regulatory Approval and Compliance

Choline C-11 has been approved for use in PET imaging for suspected prostate cancer recurrence. Its approval is based on its ability to detect disease not visualized with conventional imaging methods. The regulatory framework supports its use, with ongoing research aimed at optimizing its pharmacokinetics and clinical applications[1][4].

Pharmacokinetics and Metabolism

Understanding the pharmacokinetics of Choline C-11 is crucial for its effective use. The drug is metabolized into 11C-betaine, with the majority of the radioactivity detected as 11C-betaine in the blood within 25 minutes of administration. This metabolic profile influences its imaging protocols and the timing of PET scans[4].

Market Competition

The market for diagnostic imaging agents in oncology is competitive, with various modalities and agents available. However, Choline C-11 holds a unique position due to its specificity for prostate cancer recurrence. Its integration into clinical practice, particularly in centers with advanced PET imaging facilities, sets it apart from other diagnostic tools[5].

Economic Factors

Production Costs

Choline C-11 has a short shelf life and must be produced in specialized facilities, which can be costly. The need for integrated production, imaging, and pathology facilities adds to the overall expense. Institutions like the Mayo Clinic have invested heavily in these facilities to provide this service to patients[5].

Reimbursement and Insurance

The financial viability of Choline C-11 is also influenced by reimbursement policies. In many healthcare systems, the cost of PET imaging with Choline C-11 is covered for patients with suspected prostate cancer recurrence, making it a financially sustainable option for both patients and healthcare providers.

Research and Development

Continuous research into the pharmacokinetics and clinical applications of Choline C-11 drives its market dynamics. Studies aimed at optimizing its use, such as those investigating its role in monitoring therapy response, contribute to its growing importance in oncology[1][3].

Financial Trajectory

Current Market

The current market for Choline C-11 is stable, with a steady demand driven by the need for accurate diagnostic tools in prostate cancer management. The drug's approval and integration into clinical guidelines ensure a consistent revenue stream.

Future Prospects

The financial trajectory of Choline C-11 is expected to remain positive, driven by several factors:

• Increasing Incidence of Prostate Cancer: The rising incidence of prostate cancer and the subsequent need for effective diagnostic tools will continue to drive demand.
• Advancements in PET Imaging: Improvements in PET imaging technology and the integration of Choline C-11 into advanced imaging protocols will enhance its market position.
• Research and Development: Ongoing research into new applications, such as monitoring therapy response, will expand its clinical utility and market potential[3].

Comparison with Other Diagnostic Agents

While other diagnostic agents are available, Choline C-11's specificity for prostate cancer recurrence sets it apart. For instance, in a study comparing different imaging modalities, Choline C-11 showed higher sensitivity and specificity for detecting malignant lymph nodes compared to other methods[1].

Challenges and Opportunities

Challenges

• Production and Distribution: The short shelf life and need for specialized production facilities pose logistical challenges.
• Regulatory Hurdles: Any changes in regulatory approvals or reimbursement policies could impact its market dynamics.

Opportunities

• Expanding Clinical Applications: Research into new clinical applications, such as monitoring therapy response, could expand its market.
• Technological Advancements: Improvements in PET imaging technology could enhance the accuracy and efficiency of Choline C-11 imaging.

Key Takeaways

• Choline C-11 is a critical diagnostic agent for detecting recurrent prostate cancer.
• Its market demand is driven by the high incidence of prostate cancer recurrence.
• The drug's unique pharmacokinetics and clinical applications set it apart from other diagnostic tools.
• Ongoing research and advancements in PET imaging technology are expected to enhance its market position.
• Logistical challenges related to production and distribution need to be addressed to fully capitalize on its market potential.

FAQs

Q: What is Choline C-11 used for? A: Choline C-11 is used for positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence.

Q: How is Choline C-11 metabolized in the body? A: Choline C-11 is metabolized into 11C-betaine, with the majority of the radioactivity detected as 11C-betaine in the blood within 25 minutes of administration.

Q: What are the key challenges in the production and distribution of Choline C-11? A: The key challenges include its short shelf life and the need for specialized production facilities.

Q: How does Choline C-11 compare to other diagnostic agents for prostate cancer? A: Choline C-11 shows higher sensitivity and specificity for detecting malignant lymph nodes compared to other imaging modalities.

Q: What are the future prospects for the market of Choline C-11? A: The market is expected to remain positive, driven by the increasing incidence of prostate cancer, advancements in PET imaging technology, and ongoing research into new clinical applications.

Sources

1. 11C-Choline Pharmacokinetics in Recurrent Prostate Cancer - Journal of Nuclear Medicine[1]
2. Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride - Protara Therapeutics[2]
3. [11C]Choline as pharmacodynamic marker for therapy response - PubMed[3]
4. Choline C-11: Uses, Interactions, Mechanism of Action - DrugBank[4]
5. Choline C-11: Pulling back the curtain on prostate cancer - Mayo Clinic[5]