INDIGOTINDISULFONATE SODIUM - Generic Drug Details

What are the generic drug sources for indigotindisulfonate sodium and what is the scope of freedom to operate?

Indigotindisulfonate sodium is the generic ingredient in one branded drug marketed by Provepharm Sas and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indigotindisulfonate sodium has two patent family members in two countries.

There are two drug master file entries for indigotindisulfonate sodium. One supplier is listed for this compound.

Summary for INDIGOTINDISULFONATE SODIUM

International Patents:	2
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	6
What excipients (inactive ingredients) are in INDIGOTINDISULFONATE SODIUM?	INDIGOTINDISULFONATE SODIUM excipients list
DailyMed Link:	INDIGOTINDISULFONATE SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INDIGOTINDISULFONATE SODIUM

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INDIGOTINDISULFONATE SODIUM

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

Sponsor	Phase
Prove pharm	PHASE3
Prove pharm	Phase 4
University of Massachusetts, Worcester	Phase 3

See all INDIGOTINDISULFONATE SODIUM clinical trials

Pharmacology for INDIGOTINDISULFONATE SODIUM

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for INDIGOTINDISULFONATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes

International Patents for INDIGOTINDISULFONATE SODIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018116325
World Intellectual Property Organization (WIPO)	2018116325
European Patent Office	3559121	NOUVEAU PROCÉDÉ POUR LA PRÉPARATION D'INDIGOTINDISULFONATE DE SODIUM (CARMIN D'INDIGO) (NOVEL PROCESS FOR THE PREPARATION OF INDIGOTINDISULFONATE SODIUM (INDIGO CARMINE))
European Patent Office	3559121	NOUVEAU PROCÉDÉ POUR LA PRÉPARATION D'INDIGOTINDISULFONATE DE SODIUM (CARMIN D'INDIGO) (NOVEL PROCESS FOR THE PREPARATION OF INDIGOTINDISULFONATE SODIUM (INDIGO CARMINE))

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for Indigotindisulfonate Sodium

Introduction
Indigotindisulfonate sodium, a synthetic dye used primarily as a diagnostic agent in medical imaging, has garnered attention due to its niche application in radiology. With a longstanding history in medical diagnostics, especially in gastrointestinal and lymphatic imaging, the compound’s market potential is shaped by clinical needs, regulatory pathways, and emerging technological innovations. This analysis explores the current market environment, historical financial performance, and projected trajectories that define indigotindisulfonate sodium's role within the pharmaceutical landscape.

1. Market Overview and Demand Drivers

a. Niche Diagnostic Application
Indigotindisulfonate sodium is predominantly employed as a contrast agent in medical imaging, particularly in radionuclide scintigraphy. Its utility revolves around enhancing visualization of lymphatic pathways, gastrointestinal tracts, and vascular structures. The specificity of its application inherently limits its market size compared to broad-spectrum pharmaceuticals, but it offers high-value diagnostic insights, fostering a steady demand within specialized healthcare settings.

b. Medical Imaging Growth and Technological Advances
The global medical imaging market observed a compound annual growth rate (CAGR) of approximately 5-6% from 2018 to 2022, driven by increasing prevalence of diagnostic procedures, aging populations, and technological innovations such as hybrid imaging modalities (PET-CT, SPECT-CT). As a diagnostic agent, indigotindisulfonate sodium benefits from this overall industry expansion, although its adoption remains confined to specific clinical protocols owing to alternative imaging agents and advances in non-radioactive contrast media.

c. Regulatory Environment
Regulatory approval has historically been a critical factor governing the availability and utilization of indigotindisulfonate sodium. Its approval status varies globally, with extensive use in certain regions (e.g., Japan, Europe) and limited or restricted usage elsewhere due to concerns over safety profiles, manufacturing standards, or the availability of newer agents. Regulatory trends towards approving or restricting such agents significantly influence market size and penetration.

2. Competitive Landscape and Market Share

a. Key Players and Generic Distribution
The market for indigotindisulfonate sodium features a limited number of manufacturers, often regional or local pharmaceutical firms specializing in diagnostic radiopharmaceuticals. The entry barriers are high, given the stringent manufacturing standards, radiation safety protocols, and regulatory hurdles. Larger multinational companies tend to focus on broader contrast media portfolios, with indigotindisulfonate sodium often occupying a niche.

b. Competition from Alternative Agents
Emerging contrast agents, including non-radioactive and molecular imaging compounds, challenge indigotindisulfonate sodium’s market position. Non-radioactive dyes and advanced imaging modalities such as MRI contrast agents (e.g., gadolinium-based agents) provide safer or more versatile options, impacting the demand for traditional radiotracers. Nonetheless, indigotindisulfonate sodium remains relevant where specific diagnostic precision is required.

3. Financial Trajectory and Revenue Analysis

a. Historical Revenue Performance
Given the niche nature of indigotindisulfonate sodium, precise financial data are scarce, publicly available, or fragmented. Estimates suggest moderate revenues, heavily dependent on regional prescribing habits, regulatory approvals, and manufacturing capacity. For instance, in Japan and Europe, annual sales could range from $10-50 million, reflecting steady but modest demand.

b. Price Trends and Cost Factors
Pricing strategies are influenced by regulatory compliance, manufacturing costs, and competitive pressures. High manufacturing standards, exposure to radiation safety regulations, and specialized distribution channels contribute to higher per-unit costs. Price stability or modest growth is typical, with inflationary pressures and supply chain disruptions affecting margins.

c. Impact of Regulatory and Market Entry Barriers
Regulatory hurdles can cause market stagnation and impact revenue trajectories. Extended approval processes and post-market surveillance requirements in high-income markets limit rapid commercialization of new formulations or improved analogs. Conversely, expansion into emerging markets with favorable regulatory environments may foster incremental revenue growth.

4. Future Market Trajectory and Growth Outlook

a. Market Expansion Opportunities
Although the overall global diagnostic radiopharmaceutical market is projected to grow at a CAGR of approximately 4-5% through 2028, indigotindisulfonate sodium's specific trajectory depends on regional regulatory policies, technological advances, and clinical adoption rates. Emerging markets in Asia and Latin America offer potential for increased penetration owing to expanding healthcare infrastructure, though access to advanced imaging modalities remains a prerequisite.

b. Innovation and Pipeline Developments
Future growth hinges on innovation—either through incremental enhancements in dye formulation or via combination with novel imaging protocols. Research into safer, more effective contrast agents could either substitute or complement indigotindisulfonate sodium, potentially narrowing its market share or reviving demand if competitive advantages are established.

c. Regulatory and Policy Trends
Stricter radiation safety standards and evolving clinical guidelines emphasize the importance of safety profiles. If indigotindisulfonate sodium faces regulatory restrictions or safety concerns, the financial outlook could diminish. Conversely, positive regulatory actions and inclusion in clinical practice guidelines could bolster use.

5. Strategic Outlook and Investment Considerations

• Market Stability: The specificity and clinical niche status provide a relatively stable demand base, but innovation threats and regulatory changes are persistent risks.
• Growth Potential: Limited, primarily driven by regional expansion and aging populations requiring diagnostic procedures.
• Profitability: Margins are constrained by manufacturing costs, regulatory compliance expenses, and competition from alternative imaging agents.
• Partnership Opportunities: Collaborations with diagnostic imaging centers and regional distributors can facilitate market access, especially in emerging markets.

Key Takeaways

• Indigotindisulfonate sodium plays a specialized role in medical imaging, with demand driven mainly by diagnostic needs and regulatory approval status.
• The market operates within a niche environment, facing competition from newer contrast agents, especially non-radioactive options.
• Financial performance remains modest but stable, with revenues influenced by regional approval, clinical adoption, and manufacturing costs.
• Growth prospects are moderate, with opportunities in emerging markets and potential innovation pathways, contingent on regulatory developments.
• Strategic positioning should emphasize regulatory compliance, regional expansion, and research into next-generation imaging agents to sustain or enhance economic viability.

FAQs

1. What are the primary clinical applications of indigotindisulfonate sodium?
It is mainly used as a diagnostic radiotracer in lymphatic, gastrointestinal, and vascular imaging within nuclear medicine.

2. How does the regulatory environment impact the market for indigotindisulfonate sodium?
Regulatory approval determines market access; stricter safety standards and approval processes can limit supply and restrict usage, affecting revenue.

3. Are there emerging alternatives to indigotindisulfonate sodium in medical imaging?
Yes, non-radioactive contrast agents, molecular imaging techniques, and hybrid imaging modalities increasingly complement or replace traditional radiotracers.

4. What factors influence the pricing of indigotindisulfonate sodium?
Manufacturing costs, regulatory compliance, regional demand, and competition primarily influence pricing strategies.

5. What regions offer the most growth opportunities for this drug?
Emerging markets such as Asia-Pacific and Latin America present growth opportunities due to expanding healthcare infrastructure and diagnostic imaging adoption.

References
[1] MarketResearch.com, “Global Medical Imaging Market,” 2022.
[2] IQVIA, “Radiopharmaceuticals Market Report,” 2021.
[3] European Medicines Agency, “Radiopharmaceuticals Regulatory Framework,” 2022.
[4] GlobalData, “Emerging Trends in Diagnostic Agents,” 2023.
[5] ClinicalTrials.gov, “Current Research in Lymphatic Imaging,” 2023.