PROHANCE Drug Patent Profile

Which patents cover Prohance, and when can generic versions of Prohance launch?

Prohance is a drug marketed by Bracco and is included in two NDAs.

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

Summary for PROHANCE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	9
Patent Applications:	655
Drug Prices:	Drug price information for PROHANCE
What excipients (inactive ingredients) are in PROHANCE?	PROHANCE excipients list
DailyMed Link:	PROHANCE at DailyMed

See drug prices for PROHANCE

Recent Clinical Trials for PROHANCE

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 clinical trials

Pharmacology for PROHANCE

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

US Patents and Regulatory Information for PROHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992		RX	Yes	Yes
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes

Expired US Patents for PROHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	4,885,363
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	6,143,274
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	5,846,519

International Patents for PROHANCE

See the table below for patents covering PROHANCE 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

PROHANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ProHance

Introduction

ProHance, a gadolinium-based contrast agent, is widely used in magnetic resonance imaging (MRI) to visualize the brain, spine, and surrounding tissues. Here, we delve into the market dynamics and financial trajectory of ProHance, highlighting key factors influencing its market position and growth.

Market Size and Growth

The U.S. gadolinium-based contrast media market, which includes ProHance, was valued at USD 527.9 million in 2019 and is projected to grow at a compound annual growth rate (CAGR) of 4.7% from 2020 to 2027, reaching USD 766.4 million by 2027[1].

Segmentation and Revenue Share

The neurology segment, where ProHance is predominantly used, held approximately 38.8% of the revenue share in 2019. This significant share is due to the higher preference for gadolinium-based contrast agents (GBCAs) in neurological treatments, particularly for diagnosing CNS disorders[1].

Competitive Landscape

The market for GBCAs, including ProHance, is highly competitive with numerous domestic and international players. Companies are engaging in strategies such as label expansions, mergers, and acquisitions to strengthen their product portfolios and expand geographically. For instance, the FDA approval of GE Healthcare’s Clariscan in 2019 expanded the company’s portfolio and competitive edge in the U.S. market[1].

Pricing and Cost

The cost of ProHance varies based on the quantity and pharmacy. For example, a 25 milliliter supply of ProHance intravenous solution can cost around $166, with prices varying slightly depending on the quantity purchased[2].

Usage and Indications

ProHance is indicated for MRI to visualize the brain, spine, and surrounding tissues. It is particularly useful for diagnosing CNS disorders, providing better images of neural structures compared to CT scans. It is used for visualization of demyelinated, inflammatory, and neoplastic lesions[5].

Safety and Precautions

ProHance, like other GBCAs, carries risks such as nephrogenic systemic fibrosis (NSF) in patients with impaired kidney function. It is not approved for intrathecal use due to serious adverse reactions including death, coma, encephalopathy, and seizures. The risk of NSF is highest among patients with chronic, severe kidney disease or acute kidney injury[5].

Clinical Trials and Adverse Reactions

Clinical trials involving ProHance have shown that approximately 5.8% of subjects reported one or more adverse reactions during a follow-up period. These trials included 3174 subjects, with the majority being adults and a smaller portion being pediatric subjects. The adverse reactions were generally mild and transient[5].

Pharmaceutical Promotion and Market Impact

The promotion of pharmaceuticals, including contrast agents like ProHance, can significantly impact market dynamics. Consumer-directed and physician-directed promotion can expand the total market size rather than just affecting individual product market shares. Studies have shown that direct-to-consumer advertising (DTCA) can increase sales with an estimated elasticity of 0.10, primarily by expanding the therapeutic class market size[3].

Financial Trajectory

Given the growing demand for diagnostic imaging due to the increasing prevalence of chronic diseases, the financial trajectory for ProHance is positive. The market's CAGR of 4.7% from 2020 to 2027 indicates steady growth, driven by technological advancements and the expanding use of GBCAs in various medical indications[1].

Key Players and Market Strategies

Key players in the market, such as Bracco Diagnostics (the manufacturer of ProHance), are focusing on label expansions and strategic partnerships to maintain market share. The approval of new products and the expansion of existing product lines, such as the FDA approval of GE Healthcare’s Clariscan, are critical strategies in this competitive landscape[1].

Future Outlook

The future outlook for ProHance and the broader GBCA market is promising, driven by the increasing need for advanced diagnostic tools in healthcare. As the population ages and chronic diseases become more prevalent, the demand for accurate and detailed imaging will continue to rise, supporting the growth of the market.

Key Takeaways

• Market Growth: The U.S. gadolinium-based contrast media market is expected to grow at a CAGR of 4.7% from 2020 to 2027.
• Segment Dominance: The neurology segment dominates the market, driven by the high preference for GBCAs in neurological treatments.
• Pricing: The cost of ProHance varies but is generally around $166 for a 25 milliliter supply.
• Safety Concerns: ProHance carries risks such as NSF, particularly in patients with severe kidney disease.
• Promotion Impact: Pharmaceutical promotion can significantly expand the market size for GBCAs.

FAQs

Q: What is the primary use of ProHance in medical imaging? A: ProHance is primarily used for MRI to visualize the brain, spine, and surrounding tissues, particularly for diagnosing CNS disorders.

Q: What are the major risks associated with ProHance? A: ProHance carries risks such as nephrogenic systemic fibrosis (NSF) in patients with impaired kidney function and serious adverse reactions if used intrathecally.

Q: How is the market for gadolinium-based contrast agents expected to grow? A: The market is expected to grow at a CAGR of 4.7% from 2020 to 2027, reaching USD 766.4 million by 2027.

Q: What strategies are key players using to maintain market share? A: Key players are focusing on label expansions, strategic partnerships, and the approval of new products to maintain and expand their market share.

Q: How does pharmaceutical promotion impact the market for GBCAs like ProHance? A: Pharmaceutical promotion can significantly expand the total market size for GBCAs by increasing awareness and demand, rather than just affecting individual product market shares.

Cited Sources

1. Grand View Research - U.S. Gadolinium-based Contrast Media Market Report, 2027
2. Drugs.com - Prohance Prices, Coupons, Copay Cards & Patient Assistance
3. National Bureau of Economic Research - Effects of Pharmaceutical Promotion: A Review and Assessment
4. DrugBank - Gadoteridol: Uses, Interactions, Mechanism of Action
5. Drugs.com - ProHance: Package Insert / Prescribing Information