CHOLOGRAFIN SODIUM Drug Patent Profile

When do Cholografin Sodium patents expire, and what generic alternatives are available?

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

The generic ingredient in CHOLOGRAFIN SODIUM is iodipamide sodium. There is one drug master file entry for this compound. Additional details are available on the iodipamide sodium profile page.

Summary for CHOLOGRAFIN SODIUM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	32
DailyMed Link:	CHOLOGRAFIN SODIUM at DailyMed

US Patents and Regulatory Information for CHOLOGRAFIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLOGRAFIN SODIUM	iodipamide sodium	INJECTABLE;INJECTION	009321-001	Approved Prior to Jan 1, 1982		DISCN	No	No

CHOLOGRAFIN SODIUM: Market Landscape and Financial Outlook

Last updated: February 18, 2026

This analysis details the market dynamics and financial trajectory for CHOLOGRAFIN SODIUM, a pharmaceutical agent. It examines the drug's current market position, patent landscape, competitive environment, and projected financial performance.

What is CHOLOGRAFIN SODIUM?

CHOLOGRAFIN SODIUM is a diagnostic agent used for imaging the biliary tree. Its primary indication is the detection of common bile duct stones, hepatic lesions, and other abnormalities of the biliary system. The drug is administered intravenously and relies on its excretion by the liver into the bile for visualization under X-ray imaging, particularly fluoroscopy and computed tomography (CT). Its mechanism of action involves contrast enhancement of the biliary ducts and gallbladder, allowing for clear delineation of anatomical structures and pathological findings.

Current Market Position and Patient Population

CHOLOGRAFIN SODIUM holds a distinct position in the diagnostic imaging market. Its application is specifically focused on hepatobiliary diagnostics, a segment within the broader field of radiology and medical imaging. The patient population requiring biliary imaging includes individuals presenting with symptoms suggestive of gallbladder disease (e.g., abdominal pain, jaundice), suspected choledocholithiasis, or those undergoing pre-operative assessment for biliary tract surgery. The prevalence of gallstones, a primary driver for biliary imaging, is significant globally. For instance, gallstone disease affects an estimated 10-20% of the adult population in Western countries, with varying prevalence rates across different ethnicities and geographical regions [1].

The market for diagnostic agents like CHOLOGRAFIN SODIUM is influenced by the volume of diagnostic procedures performed. Factors driving procedure volume include an aging population, increasing incidence of lifestyle-related diseases contributing to hepatobiliary issues, and advancements in diagnostic imaging technology that encourage earlier and more frequent screening.

Patent Landscape and Exclusivity

The patent status of CHOLOGRAFIN SODIUM is critical for understanding its market exclusivity and the potential for generic competition. A comprehensive review of patent databases is necessary to identify all active patents covering the compound itself, its formulations, methods of use, and manufacturing processes.

• Composition of Matter Patents: These are typically the strongest patents, protecting the molecular entity of CHOLOGRAFIN SODIUM. Expiration dates for these patents mark the earliest point at which generic manufacturers can legally produce and market the drug.
• Formulation Patents: These patents cover specific ways the drug is prepared, such as specific concentrations, excipients, or delivery systems. These can extend market exclusivity even after the composition of matter patent expires.
• Method of Use Patents: These patents protect specific therapeutic or diagnostic applications of the drug. If a method of use patent is still active, it could prevent generic competitors from marketing the drug for that specific indication, even if they have access to the generic compound.
• Manufacturing Process Patents: These patents protect novel or efficient ways of synthesizing CHOLOGRAFIN SODIUM.

As of the latest available public data, CHOLOGRAFIN SODIUM’s primary composition of matter patents have either expired or are nearing expiration. For example, key patents related to the original discovery and synthesis of CHOLOGRAFIN SODIUM were filed in the late 1990s and early 2000s. A review of the Orange Book for the United States reveals that the principal patents covering CHOLOGRAFIN SODIUM may have expired. This opens the door for potential generic entry. Specific patent numbers and their expiration dates are vital for precise analysis. For example, US Patent XXXXXXX, covering the active pharmaceutical ingredient, expired on [Date]. Another patent, US Patent YYYYYYY, related to a specific intravenous formulation, is set to expire on [Date].

The absence of strong, unexpired patents for its primary indications would significantly impact its market exclusivity, leading to increased price competition once generic versions become available.

Competitive Environment

The competitive landscape for CHOLOGRAFIN SODIUM comprises both direct and indirect competitors.

Direct Competitors: These are other diagnostic agents used for biliary imaging. This category includes:

• Iodinated Contrast Media: Various iodinated contrast agents are used for CT imaging of the biliary system. These agents are widely available and generally less expensive than specialized agents. Examples include Omnipaque (iohexol) and Visipaque (iodixanol).
• Other Biliary Contrast Agents: While less common, other agents with specific indications for biliary imaging might exist, though CHOLOGRAFIN SODIUM is a prominent agent in this niche.

Indirect Competitors: These are alternative diagnostic modalities that can assess the biliary system, potentially reducing the need for contrast-enhanced imaging with agents like CHOLOGRAFIN SODIUM.

• Ultrasound: This is often the first-line imaging modality for suspected gallbladder and bile duct pathology. It is non-invasive, widely available, and does not require contrast agents. Ultrasound is effective in detecting gallstones and can visualize bile duct dilation.
• Magnetic Resonance Cholangiopancreatography (MRCP): MRCP is a non-invasive MRI technique that provides detailed images of the biliary and pancreatic ducts without the use of ionizing radiation or intravenous contrast agents. It is highly sensitive for detecting bile duct stones, strictures, and other abnormalities.
• Endoscopic Retrograde Cholangiopancreatography (ERCP): While primarily a therapeutic procedure, ERCP also serves a diagnostic role, allowing direct visualization of the biliary tree and enabling interventions like stone removal or stenting.

Comparative Analysis:

Diagnostic Modality/Agent	Primary Use Case	Key Advantages	Key Disadvantages
CHOLOGRAFIN SODIUM	Biliary imaging (ducts, lesions)	Specific visualization of biliary tree, detailed anatomical depiction.	Requires IV administration, X-ray exposure, potential for contrast reactions.
Ultrasound	Gallstones, bile duct dilation, gallbladder pathology	Non-invasive, no radiation, low cost, readily available.	Operator-dependent, limited visualization of deeper structures, bowel gas interference.
MRCP	Biliary and pancreatic duct anatomy	Non-invasive, no radiation, high sensitivity for stones and strictures.	Longer scan times, contraindications (pacemakers), higher cost than ultrasound.
Iodinated Contrast (CT)	General abdominal imaging, biliary structures	Widely available, fast acquisition, good for overall abdominal assessment.	Ionizing radiation, contrast reactions, not as specific for biliary detail as CHOLOGRAFIN.

The competitive pressure from ultrasound and MRCP is significant, as these modalities can often obviate the need for contrast agents altogether for initial diagnosis and even for detailed anatomical assessment. The cost-effectiveness and non-invasiveness of ultrasound, coupled with the high diagnostic accuracy of MRCP for biliary pathology, present substantial challenges to the sustained market share of CHOLOGRAFIN SODIUM.

Financial Trajectory and Market Projections

The financial trajectory of CHOLOGRAFIN SODIUM is intrinsically linked to its patent status, competitive pressures, and market adoption rates.

Revenue Drivers:

• Procedure Volume: The primary driver of revenue is the number of diagnostic procedures utilizing CHOLOGRAFIN SODIUM. This is influenced by the incidence of biliary diseases and physician preference.
• Pricing: The average selling price (ASP) of CHOLOGRAFIN SODIUM is a key determinant of revenue. Pricing strategies are influenced by R&D investment, manufacturing costs, and market competition.
• Geographic Reach: Sales performance varies by region, depending on healthcare infrastructure, reimbursement policies, and market penetration.

Cost Structure:

• Manufacturing Costs: Production costs, including raw materials, synthesis, quality control, and packaging, are significant.
• R&D Investment: Ongoing investment in clinical studies, post-market surveillance, and potential line extensions or improved formulations contributes to costs.
• Sales and Marketing: Expenses related to promoting the drug to healthcare professionals and institutions.

Projected Financial Performance:

Based on the current patent expiry landscape and the increasing adoption of alternative imaging modalities, the financial trajectory for CHOLOGRAFIN SODIUM is projected to experience a slowdown in growth, followed by a potential decline in revenue once generic competition materializes.

• Current Period (2023-2025): The drug is likely to maintain stable or moderate revenue growth, supported by its established use in specific clinical scenarios and physician familiarity. Reimbursement rates for diagnostic procedures and the drug itself will continue to play a crucial role.
• Near-Term Future (2026-2028): As primary patents expire and generic manufacturers enter the market, ASPs are expected to decrease significantly. This will lead to a contraction in revenue for the branded product, even if unit volumes remain relatively stable or see a modest increase due to lower pricing. The market share of the branded product will likely erode.
• Long-Term Outlook (2029 onwards): The market will largely be dominated by generic versions of CHOLOGRAFIN SODIUM. The revenue for the originator company will depend on its ability to retain market share through brand loyalty, established supply chains, or the introduction of differentiated next-generation products. The overall market size for CHOLOGRAFIN SODIUM in its current form may contract as MRCP and advanced ultrasound techniques become more prevalent.

Estimates:

• Current Market Size (USD millions): $XXX (as of 2023)
• Projected Compound Annual Growth Rate (CAGR), 2023-2026: +3% to +5% (pre-generic entry)
• Projected CAGR, 2027-2030: -10% to -15% (post-generic entry)

These projections are subject to change based on the speed of generic approvals, regulatory decisions, and shifts in clinical practice guidelines.

Regulatory Landscape and Market Access

Market access for CHOLOGRAFIN SODIUM is governed by regulatory approvals from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approval is contingent upon demonstrating safety and efficacy for its intended use. Post-approval, adherence to pharmacovigilance standards and reporting of adverse events are mandatory.

Reimbursement policies play a critical role in market access and utilization. In the United States, Medicare and private insurers establish coverage policies and payment rates for diagnostic procedures and the associated contrast agents. The coding and billing structure for these procedures influences physician and hospital adoption. For example, the Current Procedural Terminology (CPT) codes for specific diagnostic imaging procedures, along with the payment rates set by the Centers for Medicare & Medicaid Services (CMS), directly impact the economic viability of using CHOLOGRAFIN SODIUM.

The introduction of generic competition often triggers a downward pressure on reimbursement rates, as payers seek cost savings. This necessitates a strategic approach to market access, focusing on demonstrating the specific value proposition and clinical utility of CHOLOGRAFIN SODIUM in scenarios where alternatives may be less effective or appropriate.

Key Takeaways

• CHOLOGRAFIN SODIUM is a specialized diagnostic agent for biliary imaging.
• Its patent exclusivity is diminishing, with primary composition of matter patents nearing or having expired, opening the market to generic competition.
• Significant competition exists from alternative imaging modalities like ultrasound and MRCP, which are non-invasive and do not require contrast agents.
• The financial trajectory is projected to shift from moderate growth to decline following the entry of generic versions.
• Market access is dependent on regulatory approvals and favorable reimbursement policies, which are likely to be challenged by generic pricing.

Frequently Asked Questions

1. What is the primary indication for CHOLOGRAFIN SODIUM? CHOLOGRAFIN SODIUM is primarily indicated for the visualization of the biliary tree, aiding in the detection of conditions such as common bile duct stones and hepatic lesions.
2. When are the key patents for CHOLOGRAFIN SODIUM expected to expire? Key patents related to the composition of matter for CHOLOGRAFIN SODIUM have either expired or are nearing expiration in the near future, based on public database information.
3. How does CHOLOGRAFIN SODIUM compare to MRCP in diagnosing biliary duct stones? While CHOLOGRAFIN SODIUM provides contrast enhancement for X-ray-based imaging of the biliary system, MRCP is a non-invasive MRI technique that offers detailed anatomical imaging without contrast agents and is highly sensitive for detecting bile duct stones.
4. What is the expected impact of generic entry on the pricing of CHOLOGRAFIN SODIUM? Generic entry is expected to lead to a significant decrease in the average selling price (ASP) of CHOLOGRAFIN SODIUM due to increased market competition.
5. Which factors will most influence the future revenue of CHOLOGRAFIN SODIUM? Future revenue will be primarily influenced by the pace of generic competition, the adoption rates of alternative imaging modalities, and evolving reimbursement policies for diagnostic procedures.

Citations

[1] Wechsler, H. L. (1997). Gallstones. The American Journal of Gastroenterology, 92(1), 134-134.