ioflupane i-123 - Profile

What are the generic drug sources for ioflupane i-123 and what is the scope of patent protection?

Ioflupane i-123 is the generic ingredient in two branded drugs marketed by Ge Hlthcare Inc and Curium, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ioflupane i-123

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for ioflupane i-123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011	AP	RX	Yes	Yes
Curium	IOFLUPANE I-123	ioflupane i-123	SOLUTION;INTRAVENOUS	213792-001	Mar 30, 2022	AP	RX	No	No

Expired US Patents for ioflupane i-123

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011	5,310,912

Executive summary

Last updated: July 8, 2026

• Ioflupane I-123 (DaTscan; GE Healthcare/GE) remains the reference tracer for presynaptic dopaminergic deficit imaging in Parkinsonian syndromes, but the investment profile is constrained by exclusivity saturation risk, limited addressable new entrants, and high regulatory and imaging-demand gatekeeping.
• Near-to-midterm value drivers are (1) U.S. and ex-U.S. utilization stability in Parkinson’s disease (PD), (2) payer coverage and site-of-care economics (nuclear medicine workflow capacity), (3) supply continuity for I-123 production and distribution, and (4) replacement-cycle timing for stereotactic and imaging capacity upgrades.
• Primary patent/incentive framework centers on DaTscan’s listed U.S. exclusivities and Orange Book patent estate plus any method-of-use and formulation-related claims covering the tracer preparation and/or clinical use. Without a current Orange Book and exclusivity capture, the actionable investment view is that the asset is structurally mature, with incremental upside most dependent on volume and reimbursement rather than new product launches.

What is ioflupane I-123 (DaTscan) and why does it matter for investors?

Ioflupane I-123 is a radiopharmaceutical imaging agent used with SPECT to assess presynaptic dopaminergic function. Clinically, it is positioned in the diagnostic pathway for Parkinsonian syndromes, including differentiation of Parkinson’s disease from essential tremor and other causes of parkinsonism, using presynaptic dopaminergic deficit patterns.

What indications drive demand and utilization?

Demand is tied to:

• Neurology workflow adoption: referral patterns for nuclear imaging when clinical differentiation is uncertain.
• Diagnostic appropriateness criteria used by payers and clinicians.
• Hospital vs outpatient imaging mix, which determines throughput and scheduling stability.

Where does revenue come from commercially?

Radiopharmaceutical revenue economics depend on:

• Number of scans (dose dispensing, imaging slots, and read capacity).
• Reimbursement rates and payer acceptance for diagnostic imaging use.
• Site inventory and distribution reliability (radiopharma is logistics-sensitive).

Key investor-facing fundamentals to underwrite

• Utilization trend: scans per diagnosed patient cohort and imaging adoption rate.
• Payer dynamics: coverage policy changes that can shift demand between tracers and care settings.
• Capacity constraints: SPECT availability, technologist training, and reading expertise.

What patents protect ioflupane I-123 (DaTscan) and how strong is the patent estate?

DaTscan’s investment risk hinges on the Orange Book patent list and exclusivity expirations that govern U.S. entry pathways for generic/tracer-equivalent products.

What should be assessed in the patent estate

For ioflupane I-123, investors should map:

• Drug substance and composition claims: how protected the radiopharmaceutical preparation is.
• Formulation and kit assembly claims: whether protection extends to the dose form and packaging.
• Method-of-use claims: claims tied to clinical imaging protocols or diagnostic claims for PD differentiation.
• Manufacturing and process claims: protection that can block “work-alike” products even if the active ingredient is obtainable.

How strong is the patent estate in practice?

For mature radiopharmaceuticals, patent strength often shows up as:

• Limited commercial competition historically (a signal that enforceable claims or regulatory friction persist).
• Length and number of listed U.S. patents plus any market exclusivity blocks for follow-on applicants.
• Litigation history (if any) that indicates whether generic entry attempts were stopped by claim scope.

Investment implication

• If the U.S. Orange Book indicates multiple active patents covering either formulation/process or method-of-use, the generic threat is structurally lower and the asset behaves like a reimbursement-and-volume story.
• If the estate is thin and exclusivity has largely rolled off, the asset’s risk shifts to price compression from equivalent entrants.

When does ioflupane I-123 lose exclusivity in the U.S.?

The exclusivity clock is the primary driver of time-to-generic and therefore forward margin risk.

Investor method to determine exclusivity timing

A correct exclusivity assessment requires:

• Orange Book patent expiration dates for each listed patent.
• Any FDA-granted exclusivities (market exclusivity, protection periods, pediatric-related extensions where applicable).
• Whether any patents qualify for 30-month stays upon Paragraph IV filings.

Market behavior near exclusivity transitions

In radiopharma, even when regulatory exclusivity ends, practical competition can lag due to:

• I-123 supply chain constraints
• radiochemistry scale-up
• protocol adoption and clinician trust.

Investment implication

• Before exclusivity loss: valuation should weight stability of utilization.
• After exclusivity loss: valuation should weight probability and timeline of an approved equivalent that can clear both regulatory and commercial adoption hurdles.

How many patents cover ioflupane I-123 and what do they cover?

Investors should construct a patent scope grid by:

• Active ingredients / radiolabeling methodology
• Final kit components
• Patient preparation and scan protocols (if method-of-use claims exist)
• Manufacturing processes and purification steps
• Diagnostic readouts or classification use if claimed as method-of-use

Patent scope grid template (what to populate for underwriting)

Patent family scope	Common claim elements	Investment relevance	Generic work-around potential
Formulation/kit	kit components and preparation steps	Blocks supply chain	Moderate if equivalent kits can be built
Process	radiolabeling and QC release steps	Blocks manufacturing	High if steps are required
Method-of-use	imaging protocol and diagnostic decision support	Blocks clinical use claims	Lower if payers allow label-flexible use
Composition	chemical/radiochemical composition	Blocks direct equivalents	High if claims are broad

Are there Paragraph IV challenges for ioflupane I-123 and what do they mean for entry risk?

Paragraph IV filings are the signal for potential generic competition and timing.

How investors should interpret Paragraph IV posture

• If Paragraph IV filings exist: map the number of filers, the asserted patents, and whether litigation resulted in settlement or design-around.
• If no Paragraph IV filings: the absence can reflect either high enforcement risk or practical manufacturing barriers.

Settlement and injunction mechanics

For radiopharmaceuticals, even with favorable litigation outcomes, adoption depends on:

• readout reproducibility
• site trust and referral patterns
• purchasing behavior in nuclear medicine.

Investment implication

• Active litigation or settlements can create delayed entry windows even after exclusivity end.
• Patent wins for the reference product usually preserve price discipline longer.

What is the Orange Book status of ioflupane I-123 (DaTscan)?

The Orange Book determines:

• which patents are listed
• which are currently expired or still active
• what the controlling patents are for litigation risk

Underwriting checklist

• Patent list length
• Expiration cadence (cliff vs ladder)
• Whether any patents are clearly controlling for a generic equivalent
• Whether listed patents are mostly process/formulation or mostly method-of-use

Investment implication

• A dense, laddered patent list favors longer-term revenue defensibility.
• A short list with near-term expirations raises probability of value transfer to generic competition.

How does ioflupane I-123 compare with other neuroimaging radiotracers for investment defensibility?

Investors should frame DaTscan against alternatives in the wider neuroimaging category, including:

• other SPECT tracers
• PET tracers used for overlapping neurological workflows
• non-imaging diagnostics that reduce scan necessity

What investors should test in the competitive set

• clinical sensitivity/specificity narrative used by neurologists
• payer coverage comparisons
• imaging modality conversion costs (SPECT vs PET equipment and throughput)
• site protocol switching friction

Investment implication

• If DaTscan holds a “standard-of-care” workflow position, the asset behaves like a retention and coverage story.
• If modality switching is growing, growth depends on whether payers and sites fund conversion.

What are the FDA regulatory milestones and how do they affect supply and commercialization?

For radiopharmaceuticals, regulatory risk includes:

• manufacturing changes
• release specs
• kit component stability
• labeling protocol adherence

What matters most commercially

• Consistent approval status supports stable supply contracts.
• Regulatory friction can cause shortages or limit manufacturing upgrades.

Investment implication

• A stable FDA profile reduces “unexpected supply events,” improving the probability of steady volume.

Which companies manufacture and sell ioflupane I-123, and where are the bottlenecks?

DaTscan is generally associated with a limited set of commercial suppliers due to radiopharmaceutical manufacturing complexity.

Competitive and operational bottlenecks

• I-123 isotope supply and distribution
• radiochemical synthesis and quality control
• cold-chain logistics
• site-level scheduling constraints

Investment implication

• Supply bottlenecks can protect pricing power, but also create volatility risk that can hurt payer contracts.

What commercial metrics should investors track for ioflupane I-123?

For mature imaging tracers, the primary KPIs are volume and reimbursement.

KPI set for quarterly monitoring

• Units dispensed or number of doses shipped (proxy for scans)
• Revenue per dose and net price trends
• Contracting and channel mix (hospital vs outpatient)
• Backlog or lead times indicating supply constraints
• Any inventory or shortage indicators

Revenue exposure map

• High exposure to imaging center throughput and payer coverage.
• Moderate exposure to clinical guideline shifts.
• Low-to-moderate exposure to R&D pipeline outcomes (since no new molecular entity is expected to drive near-term growth).

What generic entry risks exist for ioflupane I-123 after exclusivity?

Generic risk is not only legal. For radiotracers, entry must clear:

• regulatory approval for equivalent performance
• manufacturing scale-up
• clinician and payer acceptance

Entry path considerations

• approval pathway (generic vs other equivalence approaches)
• whether method-of-use claims constrain label use
• whether the new entrant can supply at scale consistently

Investment implication

• Even when exclusivity ends, the speed of competition depends on operational capability and adoption cycles.

What patent litigation affects ioflupane I-123 and how would outcomes change valuation?

Litigation outcomes influence:

• ability to launch an equivalent
• launch timing due to injunctions or settlement-driven delays
• licensing and royalty burdens if cross-licensing occurs

What to model for valuation

• probability-weighted launch scenarios
• pricing compression intensity post-entry
• time-to-market and time-to-coverage approval

Investment implication

• If litigation has historically favored the reference product, valuation should use a longer post-expiry protection horizon.

How do licensing deals and settlements impact ioflupane I-123 competition?

If patents are settled via licensing:

• entrants can launch sooner under royalty terms
• price pressure still occurs, but margin erosion may be softened by royalty-sharing structures

Investment implication

• Settlement-driven licensing tends to convert litigation risk into predictable royalty economics, reducing binary downside.

Key Takeaways

• DaTscan’s investment fundamentals are dominated by utilization, payer coverage, and supply stability, with patent estate and Orange Book status governing the timing of any competitive entry.
• Exclusivity and listed U.S. patents determine the legal window, but operational and adoption barriers can extend the commercial window even after legal cliffs.
• The highest-value underwriting work is to map Orange Book patent expirations and controlling claims into a probability-weighted generic entry timeline and to monitor scan volume and net pricing as the primary quarter-to-quarter value drivers.
• Competitive risk is best modeled as a scenario tree: (1) litigation stays, (2) settlement licensing, (3) rapid equivalent launch with pricing pressure, and (4) slow adoption due to workflow constraints.

FAQs

1. What does the Orange Book tell investors about generic competition risk for ioflupane I-123?
2. How do method-of-use patents on SPECT imaging protocols change the ability to market an equivalent ioflupane I-123 product?
3. Do supply-chain constraints for I-123 affect pricing power and investor returns for ioflupane I-123?
4. How should investors evaluate payer policy shifts for Parkinsonian syndrome imaging when forecasting ioflupane I-123 volume?
5. What commercial indicators best predict whether an FDA-approved ioflupane I-123 equivalent will gain real-world adoption?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drug Approvals and Databases. U.S. Food and Drug Administration.
3. FDA. (n.d.). Radiopharmaceutical drug products: regulations and guidance. U.S. Food and Drug Administration.