CHOLETEC Drug Patent Profile

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

Choletec is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CHOLETEC is technetium tc-99m mebrofenin kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m mebrofenin kit profile page.

Summary for CHOLETEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Drug Prices:	Drug price information for CHOLETEC
What excipients (inactive ingredients) are in CHOLETEC?	CHOLETEC excipients list
DailyMed Link:	CHOLETEC at DailyMed

See drug prices for CHOLETEC

Recent Clinical Trials for CHOLETEC

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

Sponsor	Phase
National Institute of General Medical Sciences (NIGMS)	Phase 1
University of North Carolina, Chapel Hill	Phase 1

See all CHOLETEC clinical trials

US Patents and Regulatory Information for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	AP	RX	Yes	Yes

Expired US Patents for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	4,418,208

International Patents for CHOLETEC

See the table below for patents covering CHOLETEC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	7880881
Italy	8125861
South Africa	8108943
United Kingdom	2090252	N-SUBSTITUTED IMINODIACETIC ACIDS
Sweden	8107806
Austria	393357
Austria	A103384

Supplementary Protection Certificates for CHOLETEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

CHOLETEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Choletec (Technetium Tc 99m Mebrofenin)

Introduction to Choletec

Choletec, also known as Technetium Tc 99m Mebrofenin, is an iminodiacetic acid (HIDA) derivative used as a hepatobiliary imaging agent. It is utilized in medical diagnostics to visualize the liver, gallbladder, and bile ducts, aiding in the diagnosis of various hepatobiliary disorders[1][4][5].

Market Context: Radiopharmaceuticals

The radiopharmaceuticals market, within which Choletec operates, has been experiencing steady growth. This market is projected to expand from $6.46 billion in 2023 to $6.77 billion in 2024, with a compound annual growth rate (CAGR) of 4.7%. By 2028, the market is expected to reach $10.59 billion, driven by a CAGR of 11.8%[3].

Key Drivers of Market Growth

Increasing Prevalence of Cancer and Cardiovascular Diseases

The escalating prevalence of cancer and cardiovascular diseases is a significant driver for the radiopharmaceuticals market. Cancer, in particular, is the second leading cause of death globally, with projections indicating 27.5 million active cancer incidents and 16.3 million cancer deaths by 2040. This trend is expected to fuel the demand for diagnostic and therapeutic radiopharmaceuticals, including agents like Choletec[3].

Aging Population and Healthcare Spending

The increasing geriatric population and rising healthcare spending are also contributing factors. As the population ages, the demand for diagnostic imaging agents to manage age-related diseases increases, benefiting the market for radiopharmaceuticals like Choletec[3].

Technological Advancements and Innovations

The adoption of new technologies, such as 3D printing, in silico modeling, and artificial intelligence (AI), is enhancing the development and manufacturing of radiopharmaceuticals. These innovations are expected to improve product quality, reduce research and development costs, and expedite drug development, further driving the market growth[3].

Market Segmentation and End Users

Segmentation by Type

The radiopharmaceuticals market is segmented into diagnostic and therapeutic agents. Choletec falls under the diagnostic category, which is a significant segment given the increasing need for accurate and timely diagnoses of various diseases[3].

Segmentation by Application

Choletec is specifically used in hepatobiliary imaging, which is part of the broader gastroenterology segment. Other key applications include oncology, cardiology, and neurology, all of which are driving the demand for radiopharmaceuticals[3].

End Users

The primary end users of Choletec include hospitals, diagnostic centers, and cancer research institutes. The expansion of these healthcare facilities and the increasing demand for advanced diagnostic tools are contributing to the market growth[3].

Financial Trajectory

Current Market Size and Growth

The radiopharmaceuticals market, which includes Choletec, is expected to grow significantly. From $6.46 billion in 2023, the market is projected to reach $10.59 billion by 2028, indicating a robust financial trajectory driven by increasing demand and technological advancements[3].

Revenue Streams

The revenue for Choletec is generated through its use in diagnostic procedures. Given its specific application in hepatobiliary imaging, the revenue is tied to the number of procedures performed and the pricing of the drug. The financial performance of Choletec is likely to mirror the overall growth trends in the radiopharmaceuticals market[3].

Competitive Landscape

Choletec operates in a competitive market with other radiopharmaceuticals. However, its specific indication as a hepatobiliary imaging agent and its established presence in the market contribute to its financial stability. Collaborative efforts with other companies, investments in new technologies, and expanding plant capacity to meet growing demand are strategies that manufacturers like Bracco Diagnostics Inc. are employing to enhance revenues and product quality[3][5].

Challenges and Considerations

Regulatory and Safety Considerations

While Choletec is generally safe, there is a theoretical possibility of allergic reactions, especially in patients receiving multiple doses. This necessitates careful patient monitoring and adherence to safety protocols. Regulatory compliance and ongoing safety evaluations are crucial for maintaining market approval and trust[1][5].

Supply Chain and Manufacturing

The production of Choletec involves complex processes, including the use of Technetium Tc 99m, which has a short half-life of 6.02 hours. Ensuring a stable supply chain and efficient manufacturing processes is essential to meet the growing demand without compromising product quality[1][5].

Key Takeaways

• Market Growth: The radiopharmaceuticals market, including Choletec, is expected to grow significantly, driven by increasing healthcare spending, technological advancements, and the rising prevalence of cancer and cardiovascular diseases.
• Segmentation: Choletec falls under the diagnostic segment and is used primarily in gastroenterology, with key end users including hospitals and diagnostic centers.
• Financial Trajectory: The market is projected to reach $10.59 billion by 2028, with Choletec’s revenue tied to the number of diagnostic procedures and its pricing.
• Challenges: Regulatory compliance, safety monitoring, and efficient supply chain management are critical for maintaining market presence.

FAQs

What is Choletec used for?

Choletec, or Technetium Tc 99m Mebrofenin, is used as a hepatobiliary imaging agent to visualize the liver, gallbladder, and bile ducts[1][4][5].

What are the common side effects of Choletec?

Common side effects of Choletec include urticaria, rash, chills, and nausea. Rare cases of death have also been reported in association with this class of agents[1][5].

How is Choletec administered?

Choletec is administered intravenously, with the suggested dose range varying based on the patient's serum bilirubin levels[1][5].

What is the half-life of Technetium Tc 99m used in Choletec?

The half-life of Technetium Tc 99m is 6.02 hours[1][5].

What are the key drivers of the radiopharmaceuticals market growth?

The key drivers include the increasing prevalence of cancer and cardiovascular diseases, aging population, rising healthcare spending, and technological advancements[3].

Sources

1. RxList: Choletec (Technetium (99mTc) mebrofenin): Side Effects, Uses ...
2. PMC: Physiologically Based Pharmacokinetic Modeling of Transporter ...
3. ResearchAndMarkets: Radiopharmaceuticals Global Market Report 2024
4. DrugBank: Mebrofenin: Uses, Interactions, Mechanism of Action
5. Drugs.com: Choletec: Package Insert / Prescribing Information