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SODIUM ROSE BENGAL I 131 Drug Patent Profile
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When do Sodium Rose Bengal I 131 patents expire, and when can generic versions of Sodium Rose Bengal I 131 launch?
Sodium Rose Bengal I 131 is a drug marketed by Sorin and is included in one NDA.
The generic ingredient in SODIUM ROSE BENGAL I 131 is rose bengal sodium i-131. There are one hundred and four drug master file entries for this compound. Additional details are available on the rose bengal sodium i-131 profile page.
US Patents and Regulatory Information for SODIUM ROSE BENGAL I 131
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sorin | SODIUM ROSE BENGAL I 131 | rose bengal sodium i-131 | INJECTABLE;INJECTION | 017318-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
SODIUM ROSE BENGAL I 131: Investment Scenario and Fundamentals Analysis
What is Sodium Rose Bengal I 131 in commercial and regulatory terms?
Sodium Rose Bengal I 131 is a radiopharmaceutical consisting of Rose Bengal labeled with iodine-131 used for diagnostic and/or therapeutic radioisotope applications, depending on the labeled indication in each jurisdiction. The product is typically supplied as a sterile radiolabeled drug under manufacturing controls for radioactivity, stability, and radionuclide purity.
Commercially, these products sit in a narrow, highly regulated segment where value creation is driven by: (1) radionuclide sourcing and supply reliability, (2) lyophilization or solution handling (as applicable by manufacturer format), (3) radiochemical purity and sterility specs, (4) shipping and cold-chain constraints tied to short half-life logistics, and (5) reimbursement and facility readiness for nuclear medicine administration.
Who is the buyer and where is value realized?
The buyer is rarely a retail consumer. Value is realized in:
- Hospital nuclear medicine departments (dose procurement for imaging/therapeutic protocols)
- Oncology service lines for dosimetry-based workflows and patient throughput
- Specialty distributors that manage radiopharmaceutical logistics and regulatory documentation
In practice, purchasing decisions track:
- Availability and continuity of supply
- Dose yield consistency and in-vial potency (radionuclidic and radiochemical integrity)
- Turnaround time from ordering to delivery
- Label-compliant preparation and administration protocols
What are the fundamentals that drive the business case?
1) Manufacturing and quality constraints
For iodine-131 radiopharmaceuticals, the economics depend on strict control of:
- Radiochemical purity (unlabeled impurities reduce effective dose)
- Radionuclide purity (off-target iodine species reduce biological and dose delivery quality)
- Specific activity / activity concentration (determines delivered dose per vial)
- Sterility and endotoxin limits
- Stability after compounding/labeling until administration
These constraints create a barrier to entry and raise working-capital intensity due to short shelf-life tied to iodine-131 decay.
2) Supply chain bottlenecks
Key inputs for iodine-131 labeling workflows include:
- Iodine-131 production capacity and procurement
- Precursor chemistry (Rose Bengal salt and reagents)
- Radiolabeling equipment uptime
- Quality control instrumentation and release timelines
Because iodine-131 supply often tightens during outages and capacity redirection, manufacturers compete on reliability, not marketing. In radiopharma, “availability” functions like a direct pricing lever when supply constrains.
3) Competitive positioning within nuclear medicine
Sodium Rose Bengal I 131’s competitive set typically includes other iodine-131-labeled products and alternative radiotherapeutics/imaging agents used for overlapping clinical workflows. In such portfolios, buyers switch based on:
- Clinical pathway fit (protocol alignment, dosing, and monitoring)
- Regulatory label specifics
- Practical logistics (lead time and dose scheduling)
4) Reimbursement and utilization
Radiopharmaceutical utilization depends on:
- Coding and reimbursement coverage by indication and setting
- Clinical guideline uptake
- Hospital adoption (facility readiness, staffing, patient throughput)
When reimbursement is stable, contracts become long-horizon and reduce volatility. When reimbursement changes or indications narrow, volume can shift quickly between agents.
How does the patent and exclusivity landscape impact investment returns?
Patent strategy and monopoly duration
Investment outcomes in radiopharmaceuticals hinge on:
- Primary composition or labeling method protection
- Process patent coverage for specific labeling routes, purification steps, or stability enhancements
- Formulation or kit-based claims that control manufacturing reproducibility
- Regulatory exclusivity that can extend market time beyond core patents in some jurisdictions
Critical point for investors: for radiopharmaceuticals, process improvements can matter as much as chemical claims because customers place weight on release specs and consistency. A company with robust process IP can defend quality-based differentiation even after patent-by-composition barriers weaken.
Freedom-to-operate risk
The risk profile includes:
- Generic or biosimilar-style market entrants once composition claims expire (where applicable in the relevant jurisdictional framework)
- “Design-around” labeling processes that may still infringe key process claims
- Regulatory bottlenecks for manufacturing changes tied to short-lived products
What is the likely cost structure and margin profile?
Sodium Rose Bengal I 131’s unit economics are driven by:
- Short half-life logistics: higher frequency of production runs and risk of decay-based waste
- High QC cost per batch: radiochemical/radionuclide purity and sterility testing
- Regulatory compliance overhead for radiopharmaceutical manufacturing and distribution
- Working capital tied to radionuclide and batch release cycles
Margins typically improve when:
- Run size scales without QC bottleneck
- Supply agreements secure predictable ordering volumes
- Dose yield and purity reduce batch failure and rework
Margins compress when:
- Iodine-131 allocation tightens and costs rise
- Quality excursions increase release delays
- Demand softens due to guideline changes or reimbursement pressure
What investment scenarios matter most for this asset?
Scenario A: Supply-led premium (near-term positive)
Mechanism: if regional supply is constrained, buyers prioritize availability and consistent dose potency.
Investor implication: revenue growth can come from improved allocation control, contracts, and distribution coverage rather than pricing alone.
Key indicators to monitor:
- Increases in fill rates and order lead-time reductions
- Stable batch release timelines
- Contracting behavior by hospital groups and specialty distributors
Scenario B: Clinical pathway substitution (downside)
Mechanism: if an overlapping clinical indication shifts toward alternative radiotherapeutics or imaging agents, utilization declines.
Investor implication: volume risk is front-loaded and can pressure fixed costs.
Key indicators:
- Evidence of protocol shifts in oncology/nuclear medicine guidelines
- Tender outcomes showing preference changes
- Loss of formulary access or reimbursement tightening
Scenario C: Patent/process erosion (medium-term risk)
Mechanism: expiration or successful design-around of core IP reduces pricing power as more SKUs enter.
Investor implication: margin defense depends on manufacturing excellence, QC reliability, and distribution stickiness.
Key indicators:
- New entrants with comparable release specs
- Contract renegotiations favoring lowest cost per administered dose
- QC pass-rate declines or slower release times
Scenario D: Portfolio leverage (balanced upside)
Mechanism: radiopharma firms often win through multi-product supply relationships.
Investor implication: Sodium Rose Bengal I 131 can benefit from distribution, cold-chain, and hospital contracting synergies.
Key indicators:
- Growth in hospital networks served across multiple radiopharmaceuticals
- Multi-year supply commitments that include radionuclide allocation terms
Key due diligence checkpoints for investors
Focus on facts that directly impact batch economics and market access:
- Batch release metrics: time to release, QC failure rate, deviation frequency
- Radiochemical and radionuclide purity performance: pass rates over prior production cycles
- Radionuclide sourcing terms: allocation agreements, backup suppliers, lead times
- Commercial contracting: minimum purchase agreements and distribution margins
- Reimbursement stability: payer coverage and coding consistency tied to labeled uses
- Regulatory maintenance: inspection history and corrective action timelines
What would a valuation framework look like (fundamentals-first)?
A fundamentals-first approach for radiopharmaceuticals typically values the business on:
- Sustained demand (in-market utilization and contract coverage)
- Supply reliability (ability to deliver on time with compliant potency)
- Unit economics (dose yield, QC pass-rate, decay-related waste)
- Market exclusivity (time window where pricing power holds)
- Manufacturing scalability (ability to expand runs without quality loss)
A practical investor view:
- Base-case revenue scales with administered dose demand and contracting coverage.
- Gross margin tracks radionuclide cost plus QC and waste.
- Operating leverage improves if production runs stabilize and release timelines compress.
- Patent/process uncertainty drives terminal assumptions around pricing and entrant risk.
Where are the highest leverage points for R&D and business development?
1) Process robustness
Small improvements in radiochemical purity, yield, or purification reduce batch failures and increase effective dose delivered per batch.
2) Stability and release optimization
If the product format allows tighter potency windows and fewer administration delays, hospitals gain workflow reliability. That translates into contract retention.
3) Supply security
Long-term iodine-131 allocation terms can be more valuable than marginal process IP once manufacturing is already compliant.
Key Takeaways
- Sodium Rose Bengal I 131 is a niche iodine-131 radiopharmaceutical where quality, supply reliability, and short logistics windows drive commercial outcomes.
- Investment upside comes primarily from stable contracting, high QC pass rates, and radionuclide allocation control, not from broad marketing.
- Downside risks center on clinical pathway substitution, reimbursement shifts, and patent/process erosion that can reduce pricing power.
- The most actionable diligence targets are batch release performance, radiochemical/radionuclide purity outcomes, radionuclide sourcing terms, and contracting structure.
FAQs
1) What drives revenue for Sodium Rose Bengal I 131 most directly?
Dose procurement by nuclear medicine and oncology providers, governed by supply availability, label-aligned clinical protocols, and reimbursement/coding coverage.
2) What matters more for margins: pricing or manufacturing efficiency?
Manufacturing efficiency and release yield usually dominate because iodine-131 logistics and QC cost structure are fixed-per-batch and short shelf-life raises decay-related waste risk.
3) How does supply constraint change the competitive landscape?
When iodine-131 or radiolabeling capacity is tight, buyers prioritize fill rate and compliance, giving reliable manufacturers pricing leverage and contract stickiness.
4) What is the main medium-term risk to investors?
Patent/process erosion and new entrants that reduce pricing power, forcing margins to depend on QC performance and supply continuity.
5) What due diligence indicator best predicts operational stability?
Consistency of batch release timelines and QC pass rates over multiple production cycles, since they correlate with supply reliability and customer retention.
References
[1] (No sources were provided in the prompt, and no external sources are cited.)
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