When do the DRAXIMAGE DTPA patents expire, and when will generic DRAXIMAGE DTPA be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant	DRAXIMAGE DTPA	technetium tc-99m pentetate kit	INJECTABLE;INJECTION	018511-001	Dec 29, 1989	AP	RX	Yes	Yes	⤷ 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

Last updated: July 12, 2026

Executive summary: DRAXIMAGE DTPA (pentetate calcium trisodium) is an older radiopharmaceutical product with a niche diagnostic use profile and a patent/exclusivity footprint that is largely determined by legacy formulation and method-of-use IP rather than ongoing blockbuster-style exclusivity. Investment value is driven by: (i) regulatory and manufacturing supply continuity for sterile radiopharmaceutical production, (ii) payer and hospital contracting in nuclear medicine, (iii) regulatory transfer/scale risks tied to short shelf-life radiopharma logistics, and (iv) low “winner-takes-most” competitive dynamics where generics and contract-manufactured equivalents can materially pressure pricing if product identity is not strongly differentiated by IP, labeling, or regulatory exclusivity. For investors, the core diligence focus is IP status (Orange Book and any unexpired patents tied to approved NDA/ANDA), FDA labeling scope, and practical barriers to re-labelling/compounding at point-of-care distribution.

What is DRAXIMAGE DTPA and what product economics drive investment returns?

DRAXIMAGE DTPA is a radiopharmaceutical diagnostic imaging agent based on DTPA (diethylenetriaminepentaacetic acid) used to deliver imaging signals after administration, typically in contexts linked to renal function imaging and related nuclear medicine workflows. As a radiopharmaceutical, revenue and margin depend more on operational reliability and distribution logistics than on marketing intensity.

How is DRAXIMAGE DTPA sold in the US?

Investment-relevant economic drivers typically include:

Hospital and imaging center purchasing through institutional contracts.
Short shelf-life and controlled handling requirements that favor suppliers with established cold-chain and radiopharma compliance systems.
SKU complexity and dose packaging that influence inventory turns and waste rates.

Key margin levers for radiopharmaceuticals

Procurement of starting materials for DTPA chelation components and radiolabeling compatibility.
Batch yield and radiochemical purity control (quality release economics).
QA release cycle times and sterility assurance costs.
Distribution network performance and on-time delivery reliability.

What patents protect DRAXIMAGE DTPA and how many are in the estate?

Featured snippet answer: Patent protection for DRAXIMAGE DTPA is expected to be concentrated in legacy formulation, stability, packaging, and method-of-use claims that can be circumvented if a competitor keeps the same active ingredient and follows labeling-consistent administration. The number and strength of currently enforceable patents must be verified against the Orange Book for the specific approved NDA/strength/form.

What patent types matter for this product class?

For diagnostic radiopharmaceuticals, the most investable IP usually falls into:

Formulation/stability claims (e.g., excipients, pH buffering, chelation behavior, radiochemical stability).
Container-closure system claims.
Method-of-use claims tied to imaging indications in labeling.
Manufacturing/sterility assurance process claims.

Where the estate often weakens

For older radiopharmaceuticals, estates commonly weaken because:

Composition-of-matter coverage for the active chelator is older and may have expired.
Post-approval incremental patents may expire or be easy to design around without changing the active.
Competitors can pursue “same active, same use” generics if exclusivity and relevant claims do not block approval.

When does DRAXIMAGE DTPA lose exclusivity and what are the key expiration milestones?

Featured snippet answer: Exclusivity and patent expiration timing determines the primary “entry window” for competing versions. For older radiopharmaceuticals, practical exclusivity risk usually shifts first via patent expiry rather than by long regulatory exclusivity tails.

Exclusivity concepts to track for DRAXIMAGE DTPA

Patent term: last-to-expire US patent covering approved subject matter.
Orange Book: listings that can be implicated by Paragraph IV (for ANDAs) and other patent challenges.
Regulatory exclusivity: pediatric, orphan, data/market exclusivity (only if applicable to the specific approval history).

Timing risk investors model

Radiopharma supply risk and pricing pressure can accelerate before full patent expiry due to:

Manufacturing line readiness by incumbents’ competitors.
Contracting dynamics in hospital procurement with pre-approved alternates.
“Design-around” timelines once an estate weakens.

What generic entry risks exist for DRAXIMAGE DTPA?

Featured snippet answer: Generic entry risk is driven by whether any still-enforceable Orange Book patents claim formulation, stability, method of use, or specific labeling-consistent administration.

What generic pathways typically apply

For small-molecule radiopharmaceuticals, competitors often pursue ANDA approvals if the reference product is eligible for generic substitution and if patent barriers are cleared.
If the product is protected by unexpired patents, Paragraph III or IV routes determine timing and potential settlement leverage.

What factors determine whether generics reduce price

Hospital-level substitution rules and pharmacy procurement policies.
Compatibility with radiolabeling workflows and imaging protocols.
Product identity requirements in labeling (if labeling is narrow, competitors can target label-concordant use).

How strong is the patent estate for DRAXIMAGE DTPA versus typical radiopharmaceuticals?

Featured snippet answer: For legacy radiopharmaceutical products, patent estates are often narrower and easier to work around than for brand biologics or high-megahertz oral small molecules. Strength is measured by claim scope around formulation/stability and by whether those claims are still enforceable and meaningfully differentiated.

Scorecard investors use

Remaining patent term (years to expiration).
Claim breadth and whether it covers generic-identical excipient compositions.
Whether key claims are tied to manufacturing steps that competitors can’t reproduce without infringement.
Evidence of prior litigation or enforcement against generic entrants.

What would make the estate strong

Broad formulation or stability claims that define a specific excipient matrix or pH/preservative regime.
Method-of-use claims that map tightly to labeled renal imaging protocols.
Container-closure limitations that matter to radiation safety and integrity.

What would make the estate weak

Narrowly drafted claims that cover only a single presentation strength or packaging format.
Expired composition claims with only incremental process or stability patents remaining.
Settlement history indicating earlier design-around paths.

What is the Orange Book status of DRAXIMAGE DTPA?

Featured snippet answer: Orange Book status is determined by whether DRAXIMAGE DTPA’s approved NDA has active patent listings and the listed expiration dates. Patent-related investment decisions must be mapped to the exact dosage form, strength, and listed patents.

What investors should check in the Orange Book record

Drug product designation and active ingredient identifier.
Each listed patent number, patent type (composition, formulation, method of use, etc.).
Expiration dates.
Any listed exclusivity.
Whether any ANDA filers have filed Paragraph IV challenges (and if publicly available, settlement and court outcomes).

(This analysis requires an Orange Book verification step for the exact DRAXIMAGE DTPA listing.)

What FDA regulatory milestones shape near-term demand and supply risk?

Featured snippet answer: For radiopharmaceuticals, regulatory fundamentals are less about new indication exclusivity and more about ongoing cGMP compliance, chemistry-manufacturing controls, and distribution continuity.

Key regulatory diligence points

CMC stability and shelf-life justification for the specific radiopharmaceutical preparation approach.
Sterility assurance and aseptic processing controls.
Changes requiring prior approval supplements: process changes, container changes, sourcing changes for excipients.
Inspection history and any warning letters affecting continuity risk.

Manufacturing discontinuity risk investors price

Single-site manufacturing dependency.
Batch-size limitations and radiochemical yield volatility.
Regulatory tolerance for process changes in short shelf-life products.

How does DRAXIMAGE DTPA compare with alternative renal imaging radiopharmaceuticals?

Featured snippet answer: Competitive positioning in nuclear medicine depends on labeled indication overlap, ease of administration, image quality outcomes, dosing workflows, and supply reliability. Price is secondary when institutions face low tolerance for missed imaging schedules.

Competitive dimensions that matter in procurement

Labeled renal indication consistency.
Radiochemical purity and imaging readout quality.
Handling and administration workflow time.
Availability reliability (lead time, reorder cadence, missed dose penalties).

How investors should interpret “niche” competition

Even with a small addressable market, margin can hold if:

Supply continuity is strong.
Imaging sites standardize protocols with low switching costs. If supply is fragile or switching costs are low, price compression can be steep after generic availability.

What patent litigation affects DRAXIMAGE DTPA and how do settlements change launch timing?

Featured snippet answer: Patent litigation and settlements, if present, determine whether competitors launch immediately at expiry or delay through negotiated terms. In radiopharma, settlements also affect manufacturing and label substitution timing.

What to look for in litigation records

Whether any ANDA Paragraph IV suits exist for the drug product.
Whether patents are asserted against generic entrants and which patent numbers.
Court outcomes or dismissal terms and any covenant-not-to-sue scope.
Settlement-triggered “launch date” obligations that can shift market entry by quarters.

(This analysis requires a litigation record check keyed to the exact reference product and its Orange Book patents.)

What licensing deals or co-promotion models typically apply to radiopharmaceuticals like DRAXIMAGE DTPA?

Featured snippet answer: Radiopharmaceutical distribution often follows models where specialty distributors or contract manufacturers provide logistics and production capacity. The “IP license” element is frequently less central than the “manufacturing authorization and release” element.

Licensing variables that influence valuation

Whether the company holds manufacturing know-how and whether it is transferable.
Whether there is a royalty embedded in contract manufacturing.
Whether supply is exclusive by contract or subject to termination.

Investment scenario: base case, bull case, bear case

Featured snippet answer: The decision hinges on whether patent/IP barriers keep meaningful pricing power for multiple years versus whether generic substitution or supply normalization compresses price quickly.

Base case (moderate pricing pressure, steady demand)

Product remains available without supply interruptions.
Patent estate provides partial protection for specific presentation or labeled protocols.
Pricing declines occur but are offset by stable volume and contract renewals.

Bear case (rapid substitution and margin compression)

Effective generic entry occurs once key patents/exclusivity expire.
Hospitals switch due to lower acquisition cost and validated imaging performance.
Incremental costs (waste, QA, cGMP compliance) rise relative to realized net price.

Bull case (asset monetization through protected niche protocol)

Remaining patents cover formulation/stability or method-of-use with low design-around feasibility.
Supply reliability remains superior and is contracted with longer terms.
Product life extends due to lack of interchangeable alternatives and consistent imaging outcomes.

Who are the competitive players and what launch scenarios should investors model?

Featured snippet answer: Competitive players for radiopharmaceuticals are typically specialty generics, contract manufacturers, and distributors that can execute CMC at scale and maintain release quality. Launch scenarios depend on whether barriers are lifted for the exact dosage presentation.

Launch scenarios investors should model

Immediate post-expiry launch: entry triggered on the earliest non-infringing date, with aggressive hospital contracting.
Delayed launch due to CMC/inspection readiness: entry occurs later than modeled if process validation or sterility controls lag.
Narrow label substitution: competitors launch only for specific labeled imaging use with different wording or protocol constraints, limiting immediate cannibalization.

Key data tables investors should build (IP, regulatory, economics)

1) Patent and exclusivity tracker template (to be populated from Orange Book per strength)

Item	Patent/Exclusivity	Type	Practical barrier to generic
Active ingredient	Pentetate calcium trisodium	Composition	Often expired for legacy actives
Formulation	Patent ####	Formulation/Stability	Controls excipient/pH matrix
Method of use	Patent ####	Method/Use	Blocks label-concordant approvals
Packaging	Patent ####	Container/closure	Limits substitution feasibility
Data exclusivity	NDA exclusivity	Data/Market	Depends on approval history

2) Investment sensitivity map

Driver	Metric to monitor	If worse	If better
IP barrier strength	Orange Book active patents, remaining term	Faster generic price erosion	Longer pricing durability
Supply continuity	OOS rate, inspection outcomes, lead times	Missed imaging schedules, lost volume	Contract retention and premium pricing
Pricing	Net realized price per dose	Rapid discounting	Contracted volume at better margin
Demand	Hospital procedure counts using renal imaging	Lower volumes	Higher imaging utilization
Competition	Generic/alternate availability	Earlier substitution	Slower uptake

Key Takeaways

DRAXIMAGE DTPA investment fundamentals hinge on operational reliability and the enforceability of any still-active Orange Book patents tied to formulation/stability or method-of-use, not on broad, long-lived blockbuster-style exclusivity.
Generic entry risk is the dominant downside scenario; upside requires demonstrating that remaining patents materially block practical design-around and preserve labeled-protocol differentiation.
Regulatory diligence should focus on manufacturing continuity, cGMP inspection risk, and the stability of short shelf-life supply chains that affect hospital contracting.
The valuation model should be built on a patent-to-launch timeline tied to exact dosage presentations and on quantified margin sensitivity to price compression after substitution.

FAQs

How do Orange Book patent listings for DRAXIMAGE DTPA translate into generic launch timing?
What CMC and sterility assurance issues most often delay radiopharmaceutical approval or post-approval supplements?
When do hospital formularies allow substitution for imaging radiopharmaceuticals like DRAXIMAGE DTPA?
What litigation milestones typically determine whether a competitor launches immediately at patent expiry?
How should investors compare supply continuity and quality-release performance across radiopharmaceutical manufacturers?

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. Drugs@FDA. U.S. Food and Drug Administration.

US Patents:	0
Applicants:	1
NDAs:	1

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Summary for DRAXIMAGE DTPA