PROHANCE MULTIPACK Drug Patent Profile

Which patents cover Prohance Multipack, and what generic alternatives are available?

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

The generic ingredient in PROHANCE MULTIPACK is gadoteridol. One supplier is listed for this compound. Additional details are available on the gadoteridol profile page.

Summary for PROHANCE MULTIPACK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	9
Patent Applications:	655
DailyMed Link:	PROHANCE MULTIPACK at DailyMed

Recent Clinical Trials for PROHANCE MULTIPACK

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

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1
IQVIA (Sponsor)	Phase 4

See all PROHANCE MULTIPACK clinical trials

Pharmacology for PROHANCE MULTIPACK

Drug Class	Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for PROHANCE MULTIPACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes

Expired US Patents for PROHANCE MULTIPACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	4,885,363
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	6,143,274
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,846,519
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,474,756

International Patents for PROHANCE MULTIPACK

See the table below for patents covering PROHANCE MULTIPACK around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1296715	1-(SUBSTITUANT)-1,4,7-TRIS(CARBOXYMETHYL)-1,4,7,10- TETRAAZACYCLODODECANE ET COMPOSES ANALOGUES (1-SUBSTITUTED-1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGS)
Mexico	174467	1,4,7-TRISCARBOXIMETIL-1,4,7,10-TETRAAZACICLODO DECANO SUBSTITUIDO EN 1 Y COMPUESTOS ANALOGOS
Japan	S6452764	1-SUBSTITUTED 1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGUE
European Patent Office	0232751	1-SUBSTITUTED-4,7,10-TRISCARBOXYMETHYL-1,4,7,10-TETRAAZACYCLODODECANE AND ANALOGS

PROHANCE MULTIPACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ProHance Multipack

Introduction to ProHance Multipack

ProHance Multipack, a gadolinium-based paramagnetic MRI contrast agent, is used for magnetic resonance imaging (MRI) to visualize lesions with disrupted blood-brain barriers and/or abnormal vascularity in various body regions, including the central nervous system (CNS), head, neck, and associated tissues[4].

Market Indicators and Trends

Clinical Indications and Usage

ProHance Multipack is indicated for use in adults and pediatric patients, including term neonates, for MRI imaging. Its versatility in visualizing lesions in different parts of the body makes it a valuable tool in diagnostic medicine. The drug has been evaluated in several clinical trials, demonstrating its efficacy in enhancing diagnostic information in MRI scans[3][4].

Competitive Landscape

The market for MRI contrast agents is competitive, with several other gadolinium-based agents available. However, ProHance Multipack's specific formulation and indications set it apart. The drug's safety profile, particularly its lower risk of nephrogenic systemic fibrosis (NSF) compared to some other GBCAs, is a significant market advantage[1].

Regulatory Environment

Regulatory guidelines play a crucial role in the market dynamics of pharmaceuticals. ProHance Multipack is subject to strict regulations, including warnings about its use in patients with impaired renal function. Compliance with these regulations is essential for maintaining market presence[1][3].

Financial Trajectory

Revenue Streams

The revenue for ProHance Multipack is generated through sales to hospitals, imaging centers, and other healthcare facilities. The drug is supplied in pharmacy bulk packages, which can be more cost-effective for large healthcare providers. The pricing is influenced by the volume of sales, competition, and regulatory approvals[4].

Cost and Pricing

ProHance Multipack is available in 50 mL and 100 mL pharmacy bulk packages, each containing 279.3 mg/mL of gadoteridol. The pricing varies based on the package size and the region. For instance, the cost can be influenced by the healthcare system's reimbursement policies and the hospital's procurement strategies[4].

Reimbursement and Payment Policies

Reimbursement policies, especially those related to Medicare and other government healthcare programs, significantly impact the financial trajectory of ProHance Multipack. Changes in payment rates and policies, such as those outlined in the Medicare hospital outpatient prospective payment system, can affect the drug's market performance[2].

Market Challenges and Opportunities

Safety Concerns and Contraindications

One of the major challenges is the risk of nephrogenic systemic fibrosis (NSF) associated with gadolinium-based contrast agents. This risk is particularly high in patients with severe kidney disease or acute kidney injury. Managing these risks through careful patient screening and adherence to safety guidelines is crucial for maintaining market trust[1].

Technological Advancements

Advancements in MRI technology and the development of new contrast agents present both challenges and opportunities. ProHance Multipack must continue to demonstrate its efficacy and safety to remain competitive in a rapidly evolving market[4].

Patient and Healthcare Provider Perspectives

Patient Safety and Efficacy

Patients and healthcare providers prioritize the safety and efficacy of diagnostic agents. ProHance Multipack's performance in clinical trials and its safety profile are key factors in its adoption and continued use[3].

Healthcare Provider Preferences

Healthcare providers often prefer agents that are easy to administer and have a clear dosing regimen. ProHance Multipack's single-dose administration and lack of need for antimicrobial preservatives make it a convenient option[4].

Pharmacokinetics and Pharmacodynamics

Pharmacokinetic Profile

The pharmacokinetic profile of ProHance Multipack, including its distribution, metabolism, and excretion, is well-studied. The drug is primarily excreted through the kidneys, and its half-life is prolonged in patients with impaired renal function. This information is critical for dosing and safety considerations[1].

Clinical Trials and Research

Adult and Pediatric Studies

ProHance Multipack has been evaluated in both adult and pediatric populations. Clinical trials have shown that it provides significant diagnostic information, especially in visualizing lesions in the CNS and head and neck regions[3].

Global Market Presence

Distribution and Availability

ProHance Multipack is distributed globally, with its availability influenced by local regulatory approvals and market demand. The drug's global presence is a testament to its widespread acceptance and utility in diagnostic imaging[4].

Future Outlook

Market Growth Potential

The demand for MRI contrast agents is expected to grow with the increasing need for advanced diagnostic tools. ProHance Multipack, with its established safety and efficacy profile, is well-positioned to capture a significant share of this growing market.

Innovations and Developments

Continuous innovation in MRI technology and the development of new diagnostic techniques will drive the demand for high-quality contrast agents like ProHance Multipack. Staying ahead of these technological advancements will be crucial for the drug's long-term market success.

Key Takeaways

• Clinical Indications: ProHance Multipack is indicated for MRI imaging in various body regions, including the CNS and head and neck.
• Safety Profile: The drug carries a risk of NSF, particularly in patients with severe kidney disease or acute kidney injury.
• Regulatory Compliance: Adherence to regulatory guidelines is essential for maintaining market presence.
• Financial Trajectory: Revenue is influenced by sales volume, competition, and reimbursement policies.
• Market Challenges: Managing safety risks and staying competitive with technological advancements are key challenges.
• Future Outlook: The drug is well-positioned for market growth with its established safety and efficacy profile.

Frequently Asked Questions (FAQs)

Q1: What is ProHance Multipack used for? ProHance Multipack is used for magnetic resonance imaging (MRI) to visualize lesions with disrupted blood-brain barriers and/or abnormal vascularity in the central nervous system (CNS), head, neck, and associated tissues.

Q2: What are the contraindications for ProHance Multipack? ProHance Multipack is contraindicated in patients with known allergic or hypersensitivity reactions to the drug. It is also contraindicated in patients with severe kidney disease or acute kidney injury due to the risk of nephrogenic systemic fibrosis (NSF)[1].

Q3: How is ProHance Multipack administered? ProHance Multipack is administered intravenously in a single dose of 0.1 mmol/kg. It is available in 50 mL and 100 mL pharmacy bulk packages[4].

Q4: What are the potential side effects of ProHance Multipack? Common side effects include NSF in patients with impaired renal function, allergic reactions, and other adverse effects related to the administration of gadolinium-based contrast agents[1].

Q5: Is ProHance Multipack safe for pediatric patients? Yes, ProHance Multipack is safe for pediatric patients, including term neonates. Clinical trials have demonstrated its safety and efficacy in this population[3].

Cited Sources

1. ProHance Multipack - Bracco, June 2022.
2. Federal Register, Volume 72 Issue 227 - November 27, 2007.
3. ProHance Multipack (gadoteridol) Injection, Solution Pharmacy Bulk - FDA, September 4, 2007.
4. ProHance Multipack (Gadoteridol Injection) - RxList.