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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:	5
Patent Applications:	3,725
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	Phase 4
University of Massachusetts, Worcester	Phase 3
Columbia University	Phase 4

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
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y

International Patents for INDIGOTINDISULFONATE SODIUM

Country	Patent Number	Title	Estimated Expiration
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))
World Intellectual Property Organization (WIPO)	2018116325

INDIGOTINDISULFONATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Indigotindisulfonate Sodium

Introduction

Indigotindisulfonate sodium, commonly known as indigo carmine, is an organic compound with a wide range of applications, including as a diagnostic agent in medical procedures. Recently, it has gained significant attention with the FDA approval of BLUDIGO™, an indigo carmine injectable product. Here, we delve into the market dynamics and financial trajectory of this drug.

Medical Use and FDA Approval

Indigotindisulfonate sodium is primarily used as a diagnostic dye in medical procedures. Specifically, BLUDIGO™, approved by the FDA in July 2022, is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological surgical procedures[1].

Market Demand and Growth

The demand for diagnostic dyes like indigo carmine is driven by the increasing need for precise and reliable diagnostic tools in surgical settings. With the FDA approval of BLUDIGO™, Provepharm has tapped into this growing market, particularly in the U.S., where there is a high demand for advanced diagnostic agents.

Competitive Landscape

The pharmaceutical market for diagnostic agents is competitive, with various products vying for market share. However, the approval of BLUDIGO™ marks a significant milestone for Provepharm, positioning the company as a key player in this niche market. The success of BLUDIGO™ is expected to influence the competitive dynamics, potentially leading to increased innovation and competition in diagnostic dyes[1].

Pricing and Cost Analysis

The pricing of indigotindisulfonate sodium can vary based on the formulation and the specific use case. For instance, the charge for an 8 mg/mL (0.8%) IV solution of indigotindisulfonate sodium is listed at $2,600.00 in some hospital charge masters[2].

Revenue Projections

Given the FDA approval and the growing demand for diagnostic agents, the revenue projections for BLUDIGO™ are promising. Provepharm's strategy of investing heavily in R&D and expanding its product portfolio is expected to yield significant financial returns. The company's previous success with methylene blue injection products in the U.S. market sets a positive precedent for the financial performance of BLUDIGO™[1].

Financial Impact on Provepharm

The approval of BLUDIGO™ is a significant financial boost for Provepharm. It validates the company's R&D strategy and is expected to contribute substantially to its revenue. Michel Féraud, president and founder of Provepharm, highlighted the company's pride in achieving this milestone, indicating a positive outlook on the financial implications of this approval[1].

Market Trends and Drivers

The pharmaceutical market is driven by several trends, including the increasing use of generic and biosimilar products, which can impact the pricing and revenue of branded products. However, diagnostic agents like indigo carmine, which serve specific medical needs, tend to maintain their market value due to their unique applications and the lack of direct generic substitutes[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products. The FDA approval of BLUDIGO™ underscores the stringent regulatory standards that must be met, ensuring the safety and efficacy of the product. Compliance with these regulations is essential for maintaining market presence and trust among healthcare professionals and patients[1].

Global Expansion

Provepharm's strategy includes expanding its operations globally, with a strong presence in both Europe and the United States. The approval of BLUDIGO™ in the U.S. market is a step towards this global expansion, indicating potential future approvals and market entries in other regions[1].

Side Effects and Safety Profile

While indigo carmine is generally considered safe for its intended use, it is important to monitor for any adverse reactions. The safety profile of BLUDIGO™ has been evaluated during the FDA approval process, ensuring that it meets the necessary safety standards for use in clinical settings[4].

Future Outlook

The future outlook for indigotindisulfonate sodium, particularly BLUDIGO™, is positive. With ongoing advancements in medical diagnostics and the increasing need for precise visualization tools, the demand for this product is expected to grow. Provepharm's commitment to R&D and its global expansion strategy position the company well for future success in this market.

Key Takeaways

• FDA Approval: BLUDIGO™ received FDA approval in July 2022 for use as a diagnostic dye in cystoscopic assessments.
• Market Demand: Growing demand for advanced diagnostic agents drives the market for indigo carmine.
• Pricing: The cost of indigotindisulfonate sodium solutions varies, with a listed charge of $2,600.00 for an 8 mg/mL solution.
• Revenue Projections: Positive revenue projections due to the unique application and growing demand.
• Financial Impact: Significant financial boost for Provepharm, validating its R&D strategy.
• Market Trends: Driven by the need for specific medical applications, maintaining market value despite generic and biosimilar trends.
• Regulatory Environment: Compliance with FDA standards ensures safety and efficacy.

FAQs

Q: What is the primary medical use of indigotindisulfonate sodium? A: Indigotindisulfonate sodium is used as a diagnostic dye for the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological surgical procedures.

Q: Which company received FDA approval for BLUDIGO™? A: Provepharm received FDA approval for BLUDIGO™ in July 2022.

Q: How much does an 8 mg/mL (0.8%) IV solution of indigotindisulfonate sodium cost? A: The listed charge for an 8 mg/mL (0.8%) IV solution of indigotindisulfonate sodium is $2,600.00.

Q: What are the potential side effects of indigo carmine? A: While generally considered safe, it is important to monitor for any adverse reactions. The safety profile has been evaluated during the FDA approval process.

Q: What is Provepharm's strategy for expanding its market presence? A: Provepharm aims to expand its operations globally, with a strong presence in both Europe and the United States, and continues to invest heavily in R&D.

Sources

1. Provepharm - Provepharm receives FDA marketing approval in US for BLUDIGO (indigotindisulfonate sodium, USP) Injection.
2. MemorialCare - Updated 12/21/2023 - MemorialCare.
3. IQVIA - Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context U.S Detail Appendix.
4. Macsen Labs - Indigo Carmine | Structure, Properties, Uses & Side effects.