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Last Updated: March 25, 2025

Rose bengal sodium i-131 - Generic Drug Details


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What are the generic sources for rose bengal sodium i-131 and what is the scope of patent protection?

Rose bengal sodium i-131 is the generic ingredient in two branded drugs marketed by Bracco and Sorin, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for rose bengal sodium i-131
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Clinical Trials: 3
DailyMed Link:rose bengal sodium i-131 at DailyMed
Recent Clinical Trials for rose bengal sodium i-131

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

SponsorPhase
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshN/A
Universidade Federal do Rio de JaneiroPhase 4
Santen Pharmaceutical Co., Ltd.Phase 3

See all rose bengal sodium i-131 clinical trials

Medical Subject Heading (MeSH) Categories for rose bengal sodium i-131
Anatomical Therapeutic Chemical (ATC) Classes for rose bengal sodium i-131

US Patents and Regulatory Information for rose bengal sodium i-131

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bracco ROBENGATOPE rose bengal sodium i-131 INJECTABLE;INJECTION 016224-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bracco ROBENGATOPE rose bengal sodium i-131 INJECTABLE;INJECTION 016224-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bracco ROBENGATOPE rose bengal sodium i-131 INJECTABLE;INJECTION 016224-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sorin SODIUM ROSE BENGAL I 131 rose bengal sodium i-131 INJECTABLE;INJECTION 017318-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Rose Bengal Sodium I-131

Introduction

Rose Bengal sodium I-131 is a radiopharmaceutical that has been utilized in various medical applications, including the diagnosis of liver and biliary disorders, and more recently, in the context of broader nuclear medicine practices. This article delves into the market dynamics and financial trajectory of this drug, highlighting its current status, future prospects, and the factors influencing its market.

Historical Context and Development

Rose Bengal sodium I-131 was first developed in the 1950s by Taplin et al. for testing liver function. It has since been used in radionuclide imaging to assess the hepatobiliary system, particularly in cases of suspected biliary atresia in infants[2].

Medical Applications

The primary medical application of rose Bengal sodium I-131 is in the diagnosis of biliary atresia and other liver and biliary disorders. The radiopharmaceutical is administered, and its clearance from the liver and appearance in the gut are monitored to determine the presence or absence of biliary obstruction. This method is particularly useful in pediatric patients where early diagnosis is crucial[2].

Market Size and Growth

While rose Bengal sodium I-131 is a specific radiopharmaceutical, its market dynamics are closely tied to the broader sodium iodine (I-131) drugs market. The global sodium iodine (I-131) drugs market is expected to grow at a Compound Annual Growth Rate (CAGR) of 12.7% from 2023 to 2033. This growth is driven by increasing cases of thyroid cancer and hyperthyroidism, as well as advancements in medical imaging and targeted radiotherapy techniques[3].

Key Market Drivers

  • Increasing Prevalence of Thyroid Disorders: The rise in thyroid cancer and hyperthyroidism cases has led to a higher demand for effective treatment options like sodium iodine (I-131) drugs.
  • Advancements in Medical Imaging: Improvements in diagnostic technologies have enhanced the detection and treatment of thyroid-related issues, contributing to the growth of the market.
  • Targeted Radiotherapy: The precision and safety of targeted radiotherapy using I-131 have made it a preferred treatment option, driving market growth[3].

Market Segmentation

The sodium iodine (I-131) drugs market is segmented based on type (capsules and oral solutions) and application area. Capsules are the dominant form due to their ease of use, higher stability, and longer shelf life compared to liquid formulations[3].

Regional Market Analysis

North America holds the largest market share due to its well-established healthcare infrastructure, access to advanced medical technologies, and a comprehensive network of specialized medical centers. Other regions, including Europe, Asia-Pacific, the Middle East & Africa, and South America, also contribute significantly to the market[3].

Key Players

Major players in the sodium iodine (I-131) drugs market include Mallinckrodt, AnazaoHealth, International Isotopes, Bracco, Jubilant Radiopharma, and others. These companies are involved in the production, distribution, and innovation of radiopharmaceuticals, including rose Bengal sodium I-131[3].

Challenges and Risks

Despite the growth prospects, the market faces challenges such as:

  • Radiation Exposure Risks: Patients and healthcare workers are exposed to radiation, which necessitates strict safety protocols.
  • Regulatory Compliance: Stringent regulations govern the production, storage, and administration of radiopharmaceuticals, adding to the operational complexity and cost[3].

Innovations and Future Prospects

  • Improved Dosimetry: Advances in dosimetry are enabling more precise and effective treatments, reducing side effects and improving patient outcomes.
  • New Formulations: The development of new formulations, such as the use of I-123 instead of I-131 for rose bengal, reduces patient exposure to radiation and improves imaging quality[1].

Financial Trajectory

The financial trajectory of rose Bengal sodium I-131 is closely aligned with the broader sodium iodine (I-131) drugs market. With a projected CAGR of 12.7%, the market is expected to see significant financial growth. The ease of administration, higher stability, and preference for capsule forms are expected to drive revenue growth. Additionally, investments in research and development by key players will continue to innovate and expand the market[3].

Conclusion

The market for rose Bengal sodium I-131 is part of the larger and growing sodium iodine (I-131) drugs market. Driven by increasing demand for effective treatments of thyroid disorders and advancements in medical imaging and targeted radiotherapy, this market is poised for significant growth. However, it must navigate challenges related to radiation exposure and regulatory compliance.

Key Takeaways

  • The global sodium iodine (I-131) drugs market is expected to grow at a CAGR of 12.7% from 2023 to 2033.
  • Rose Bengal sodium I-131 is used primarily in diagnosing liver and biliary disorders.
  • Advancements in medical imaging and targeted radiotherapy are key drivers of market growth.
  • North America holds the largest market share due to its advanced healthcare infrastructure.
  • Major players are investing in research and development to innovate and expand the market.

Frequently Asked Questions

Q1: What is the primary use of rose Bengal sodium I-131 in medical diagnostics?

  • Rose Bengal sodium I-131 is primarily used in the diagnosis of liver and biliary disorders, such as biliary atresia in infants.

Q2: What is the expected growth rate of the sodium iodine (I-131) drugs market?

  • The global sodium iodine (I-131) drugs market is expected to grow at a CAGR of 12.7% from 2023 to 2033.

Q3: Which region holds the largest market share for sodium iodine (I-131) drugs?

  • North America holds the largest market share due to its well-established healthcare infrastructure and access to advanced medical technologies.

Q4: What are the key challenges faced by the sodium iodine (I-131) drugs market?

  • The market faces challenges related to radiation exposure risks and stringent regulatory compliance.

Q5: Who are the major players in the sodium iodine (I-131) drugs market?

  • Major players include Mallinckrodt, AnazaoHealth, International Isotopes, Bracco, and Jubilant Radiopharma, among others.

Cited Sources:

  1. Serafini, A. N., et al. "Preparation and Distribution of 123I-Labeled Rose Bengal." Journal of Nuclear Medicine, vol. 16, no. 7, 1975, pp. 629-636.
  2. Treves, S., et al. "Rose Bengal Sodium I 131 Studies in Infants with Suspected Biliary Atresia." Pediatrics, vol. 55, no. 3, 1975, pp. 334-340.
  3. Market Statsville Group. "Global Sodium Iodine (I-131) Drugs Market." Market Statsville Group, 2023.

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