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INDIUM IN-111 PENTETATE DISODIUM - Generic Drug Details
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What are the generic drug sources for indium in-111 pentetate disodium and what is the scope of patent protection?
Indium in-111 pentetate disodium
is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for INDIUM IN-111 PENTETATE DISODIUM
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in INDIUM IN-111 PENTETATE DISODIUM? | INDIUM IN-111 PENTETATE DISODIUM excipients list |
| DailyMed Link: | INDIUM IN-111 PENTETATE DISODIUM at DailyMed |
US Patents and Regulatory Information for INDIUM IN-111 PENTETATE DISODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | MPI INDIUM DTPA IN 111 | indium in-111 pentetate disodium | INJECTABLE;INTRATHECAL | 017707-001 | Feb 18, 1982 | RX | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Financial Trajectory for Indium In-111 Pentetate Disodium
Introduction
Indium In-111 Pentetate Disodium, commercially known as Capromab Pendetide or as a radiopharmaceutical used predominantly in nuclear medicine, plays a crucial role in diagnostic imaging. Leveraging its ability to target specific tissues, primarily prostate cancer, its market growth is influenced by the evolving landscape of nuclear medicine, technological innovations, and regulatory considerations. This article examines the current market dynamics, financial trajectory, and future prospects of Indium In-111 Pentetate Disodium within the pharmaceutical industry.
Product Overview and Medical Application
Indium In-111 Pentetate Disodium is a radiopharmaceutical characterized by its radioactive isotope, Indium-111, chelated with pentetate (DTPA). Its primary function is to serve as a diagnostic agent in various imaging procedures, including sentinel lymph node mapping and tumor localization. It is especially utilized in scintigraphy for prostate cancer detection, leveraging its affinity for prostate-specific membrane antigen (PSMA) expressing tissues [1].
The diagnostic precision offered by In-111 Pentetate Disodium improves the staging and management of prostate cancer, enabling personalized treatment plans. Such targeted applications are contingent on the development of advanced imaging technologies and the biomarker landscape.
Market Dynamics
1. Growing Demand for Nuclear Diagnostic Agents
The global nuclear medicine market, valued at approximately USD 8.8 billion in 2022, is expected to witness a compound annual growth rate (CAGR) of 8.2% through 2030 [2]. A key driver for In-111 Pentetate Disodium is the rising incidence of prostate cancer, the second most common cancer among men worldwide [3], leading to increased demand for precise diagnostic agents.
Furthermore, advances in SPECT imaging systems enhance the utility of In-111-based radiopharmaceuticals, increasing their clinical adoption. As SPECT technology becomes more accessible and affordable, hospitals and imaging centers expand their nuclear medicine capabilities, reinforcing market demand.
2. Regulatory Landscape and Approvals
Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), influence market growth through approval processes, labeling updates, and safety standards. While In-111 Pentetate Disodium has long-standing approval for certain indications, ongoing clinical trials and expanded indications can stimulate regulatory endorsements, opening new revenue streams.
However, regulatory hurdles and stringent safety protocols around radioactive substances can hinder rapid market penetration, especially in emerging markets. The meticulous requirement for manufacturing consistency and safety measures increases operational costs but assures quality, sustaining demand among healthcare providers.
3. Competitive Environment and Innovation
The market for radiopharmaceuticals faces competition from newer isotopes such as Gallium-68 and Fluorine-18, which facilitate PET imaging with higher resolution. Nonetheless, In-111 remains relevant due to its nuclear half-life suited for longer imaging windows and dosimetric benefits in specific applications.
Innovations enhancing targeted delivery, multi-modal imaging, and combination protocols with other therapies could bolster In-111’s market position. Companies investing in R&D to develop next-generation variants or co-developed diagnostic kits will gain competitive advantage.
4. Supply Chain and Manufacturing Considerations
Indium-111 production hinges on reactor-based origins, primarily obtained from neutron activation of enriched cadmium targets. The limited global supply and high costs of isotope production influence pricing and availability.
Manufacturing complexities, including adherence to Good Manufacturing Practices (GMP) and ensuring isotope purity, create barriers entry for new players but solidify incumbents with established production capabilities. Strategic collaborations with reactor facilities and isotope suppliers are critical for stable supply chains.
5. Healthcare Economics and Reimbursement Policies
Reimbursement policies significantly shape market uptake. Favorable insurance coverage and national health schemes for nuclear imaging procedures facilitate patient access. Conversely, high out-of-pocket costs can limit utilization, especially where alternative non-radioactive modalities exist.
Cost-effectiveness analyses underscore the value of In-111-based diagnostics in improving patient outcomes and reducing invasive procedures, bolstering policy support.
Financial Trajectory and Investment Outlook
1. Revenue Trends and Market Share
Historical data indicates moderate but steady revenues for Indium In-111 radiopharmaceuticals, primarily driven by clinical adoption in prostate cancer diagnostics. The global market segment for In-111-based imaging agents is projected to grow at a CAGR of around 5-7% until 2030, aligned with overarching nuclear medicine expansion.
Major commercial manufacturers, such as Lantheus Medical Imaging and Jubilant Radiopharma, maintain dominant market shares due to extensive distribution networks and compliance with regulatory standards [4].
2. Investment in R&D and Pipeline Development
Investments in R&D focus on expanding indication breadth, improving targeting accuracy, and integrating theranostic capabilities. Companies exploring combination diagnostic/therapeutic agents, leveraging In-111’s properties, could open new revenue avenues.
Notably, clinical trials assessing In-111 labeled monoclonal antibodies for various cancers could diversify application scopes. However, regulatory and technical challenges impose substantial barriers, demanding significant capital expenditure and strategic alliances.
3. Pricing Dynamics and Cost-Management
Pricing strategies for In-111 agents consider production costs, competitive landscape, and reimbursement frameworks. A typical dose costing between USD 2,000–4,000 reflects the complex manufacturing process, isotope costs, and regulatory fees.
Price pressures from emerging alternatives could necessitate value-based pricing models emphasizing diagnostic accuracy and patient outcomes, impacting profit margins.
4. Market Risks and Challenges
Key risks include isotope supply constraints, regulatory delays, technological obsolescence, and healthcare policy shifts. Addressing these risks requires robust supply chain management, active engagement with regulatory authorities, and continuous innovation.
Additionally, environmental and safety concerns surrounding radioactive waste management pose compliance challenges, influencing long-term financial planning.
Future Outlook and Strategic Opportunities
The trajectory of In-111 Pentetate Disodium hinges upon its integration into personalized medicine frameworks, technological adoption, and evolving healthcare policies. Its role in prostate cancer diagnosis remains pivotal, but expanding applications in neuroendocrine tumors and lymphoma could augment growth.
Emerging trends include the development of hybrid imaging modalities, enhancing diagnostic precision. Strategic investments toward isotope production infrastructure and R&D collaborations can secure supply stability and foster innovation.
In conclusion, the market for Indium In-111 Pentetate Disodium is poised for steady growth, underpinned by increasing demand for precise nuclear diagnostics, technological advancements, and supportive regulatory environments. Firms that navigate supply chain complexities, innovate in targeting strategies, and align with healthcare policy shifts will bolster their financial trajectory.
Key Takeaways
- Growing Market Demand: Driven by rising prostate cancer diagnostics and advancements in SPECT imaging technology.
- Regulatory & Supply Chain Factors: Regulatory approvals and isotope supply constraints significantly influence market accessibility and costs.
- Competitive Landscape: While In-111 remains relevant, competition from PET isotopes prompts innovation and differentiation.
- Investment Focus: R&D, supply chain robustness, and strategic partnerships are vital for capturing future market share.
- Financial Outlook: Moderate but consistent revenue growth expected, contingent on technological adoption and healthcare reimbursement policies.
FAQs
1. What are the primary clinical indications for Indium In-111 Pentetate Disodium?
It is chiefly used in scintigraphy to detect prostate cancer, lymph node mapping, and in certain neuroendocrine tumor diagnostics.
2. How does the supply chain affect the market of In-111 radiopharmaceuticals?
Limited production facilities, dependence on neutron reactors, and high isotope costs restrict supply stability, affecting pricing and availability.
3. What technological advances could enhance the market prospects of In-111-based agents?
Hybrid imaging combining SPECT with other modalities, targeted delivery systems, and theranostic applications can expand usage.
4. How does reimbursement influence the adoption of In-111 radiopharmaceuticals?
Favorable reimbursement policies promote adoption by reducing patient costs and encouraging hospital investment, whereas unfavorable policies can hinder growth.
5. What future developments could disrupt the market for Indium In-111 Pentetate Disodium?
Emergence of superior imaging isotopes, alternative diagnostic methods, or shifts in clinical guidelines away from nuclear medicine could impact market trajectory.
References
[1] European Society of Nuclear Medicine. "Radiopharmaceuticals in Prostate Cancer." ESNM Reports, 2022.
[2] MarketsandMarkets. "Nuclear Medicine Market — Global Forecast to 2030." 2022.
[3] World Health Organization. "Cancer Fact Sheets: Prostate Cancer." 2022.
[4] IQVIA. "Nuclear Medicine Market Insights." 2022.
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