CARDIOGRAFIN Drug Patent Profile

When do Cardiografin patents expire, and when can generic versions of Cardiografin launch?

Cardiografin is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CARDIOGRAFIN is diatrizoate meglumine. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diatrizoate meglumine profile page.

Summary for CARDIOGRAFIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	992
DailyMed Link:	CARDIOGRAFIN at DailyMed

US Patents and Regulatory Information for CARDIOGRAFIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CARDIOGRAFIN	diatrizoate meglumine	INJECTABLE;INJECTION	011620-002	Approved Prior to Jan 1, 1982		DISCN	No	No

CARDIOGRAFIN market dynamics and financial trajectory: pricing, demand, competition, exclusivity, and revenue exposure

Last updated: June 24, 2026

CARDIOGRAFIN’s market dynamics are shaped by its role as a contrast media product in imaging, periodic reimbursement pressure, tender-driven procurement, and the narrowing of long-cycle revenue due to competitive substitution and regulatory listing evolution. Financial trajectory risk is concentrated in (i) formulary and tender retention, (ii) downstream channel stocking shifts as supply chains normalize, and (iii) patent and exclusivity turnover for the relevant active and presentation in each geography.

What is CARDIOGRAFIN and what market does it serve?

CARDIOGRAFIN is a radiographic contrast medium product used in diagnostic imaging. Its commercial footprint typically depends on hospital imaging volumes, procurement contracting, and the presence of alternative iodinated contrast agents across major hospital systems.

Key commercial demand drivers

• Imaging utilization: CT and other radiography use patterns drive unit consumption.
• Hospital procurement cycles: national and regional tenders determine share more than brand-level advertising.
• Substitution risk: clinicians and procurement teams can switch between iodinated contrast brands based on price, supply assurance, and clinical protocols.
• Safety protocols and administration practices: product label fit for patient populations influences formulary inclusion.

Product form factor and competitive set

CARDIOGRAFIN’s competitive landscape is generally defined by:

• Other iodinated contrast media brands (same imaging indications, alternative molecules where available).
• Generic or authorized alternatives in markets where patents and registrations allow.
• Supply chain reliability in contrast media procurement, which can outweigh marginal clinical differences in contracting decisions.

How do pricing and reimbursement pressures affect CARDIOGRAFIN revenue?

Revenue trajectory for contrast media products often tracks tender economics rather than retail dynamics. Pricing pressure typically comes from:

• Tender compression: hospital systems seek multi-year price reductions at renewal.
• Tender re-basing after supply shocks: price paid can swing as capacity returns.
• Reimbursement dynamics: in some healthcare systems, reimbursement caps or DRG-based cost controls indirectly force price concessions.

What tends to move gross-to-net

• Contract rebates tied to volume thresholds.
• Tender-linked concessions that lower effective net price even if list pricing remains stable.
• Preference policies for designated procurement formularies.

When does CARDIOGRAFIN lose exclusivity and what does that mean commercially?

For exclusivity, the commercial risk is less about a single global date and more about geography-by-geography patent and data exclusivity outcomes that enable generic entry or authorized equivalents. In contrast media, “effective exclusivity” often degrades when authorized alternatives gain formulary and tender placement, even before full patent expiry.

Common exclusivity and competition transition mechanics

• Authorized generic or authorized equivalent: enters via regulatory approval pathway without full brand parity.
• Tender replacement: even if patents remain, procurement can shift if a competitor is included in panel lists.
• Parallel imports or alternative supply chains: can change pricing in ways that mimic post-expiry dynamics.

What is the competitive landscape for CARDIOGRAFIN and how does it compare with alternative iodinated contrast media?

CARDIOGRAFIN competes primarily within iodinated contrast media. The competitive axis usually combines:

• Price and total cost per administration
• Supply reliability and lead times
• Pack size and procurement fit
• Label and clinical protocol alignment

Competitive selection criteria in hospital procurement

• Total acquisition cost per imaging procedure
• Stability and shelf-life logistics
• Administration device compatibility (where relevant)
• Clinical protocol acceptance and pharmacovigilance record

Brand vs. authorized equivalent risk

The highest revenue exposure tends to be in accounts where:

• Multiple suppliers are qualified and switching is permitted.
• Tender criteria weight price and availability more than branding.

What regulatory and FDA/EMA status issues influence CARDIOGRAFIN market trajectory?

Contrast media products are governed by product registration, manufacturing controls, and pharmacovigilance requirements. Market expansion or contraction generally follows:

• Maintenance of marketing authorization and variations
• Changes in manufacturing sites, process validation, and quality systems
• Label updates that can affect hospital protocol adoption

Regulatory levers that move demand

• New indications or protocol updates that expand imaging usage.
• Safety or quality communications that can restrict uptake temporarily.
• Batch-level supply events that shift switching behavior and tender eligibility.

What patents protect CARDIOGRAFIN and how strong is the patent estate?

Patent landscapes for contrast media products depend on the specific active ingredient and marketed presentation (strength, pack form, and manufacturing route). Without validated patent identifiers tied to CARDIOGRAFIN’s exact marketed formulations by geography, a complete patent inventory cannot be produced in a way that supports licensing, challenge, or litigation decisions.

What generic entry risks exist for CARDIOGRAFIN in the US and EU?

Generic and authorized equivalent risks are typically highest where:

• The active substance is widely known and older patents have expired.
• Manufacturing and process claims are weak or already designed around.
• Regulatory approvals can rely on prior safety/efficacy data.

What triggers material revenue impact

• Panel removal or unfavorable placement in formularies.
• Tender awards to lower-priced alternatives.
• Supply substitution after competitor availability improvements.

How do hospital tender dynamics translate into quarterly financial trajectory for CARDIOGRAFIN?

Contrast media revenue often shows quarter-to-quarter variability driven by tender timing and consumption swings:

• Pre-tender stocking: customers increase orders ahead of bid deadlines.
• Post-award reallocation: volumes shift to the winning supplier after contract starts.
• Inventory destocking: if supply was delayed, follow-up quarters can show normalization volatility.

Indicators used by market participants

• Contract award announcements and supplier lists
• Distribution partner inventory levels
• Procurement contract renewal dates
• Supply disruptions that cause account switching

How does supply and manufacturing capacity affect CARDIOGRAFIN availability and sales?

Contrast media is sensitive to manufacturing throughput, packaging lines, and quality batch release. Financial effects show up as:

• Allocation periods where demand exceeds supply
• Temporary shipment constraints that lead to account switching
• Higher logistics costs during supply tightness

Manufacturing IP barriers

Where manufacturing know-how is protected, it can act as a barrier to rapid generic scaling. Where not, the primary barrier becomes regulatory and quality execution capacity.

What litigation or settlement activity could affect CARDIOGRAFIN revenue?

Material litigation events typically alter commercial outcomes through:

• Temporary injunction risk (rare for established injectables unless tightly coupled to approval timelines).
• Settlement terms that can delay or scope generic entry.
• Coexistence or carve-outs that keep brand share in certain presentations or strengths.

Without verified case dockets tied to CARDIOGRAFIN’s exact US/EU product identifiers, a factual litigation map cannot be generated.

What is the revenue exposure by geography for CARDIOGRAFIN?

Geographic exposure is driven by:

• Tender concentration in hospital networks
• Local reimbursement and price regulation
• Availability of local authorized competitors
• Regulatory maturity and market access status

How to model geography risk

• Tier 1 markets: tends to show contract-driven stability but high tender competition.
• Tier 2/3 markets: higher switching and higher volatility from supply and regulatory changes.

What is CARDIOGRAFIN’s financial trajectory based on market indicators (not company-specific)?

In the absence of verified company financials tied to CARDIOGRAFIN product reporting, the financial trajectory direction can be characterized by market forces:

• Downward pressure from tender-driven price reductions is common across iodinated contrast categories as competition increases.
• Demand growth follows imaging volume and aging demographics but can lag when switching to competitors occurs faster than utilization growth.
• Gross-to-net erosion typically increases with rebate and tender concession structures.

Base-case commercial path assumptions consistent with the category

• Stable-to-declining net pricing with volume growth partially offsetting.
• Periodic step-downs in share after major tender renewals.
• Supply-related shocks causing short-term volatility but not permanent loss unless converted into tender reallocation.

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Key Takeaways

• CARDIOGRAFIN revenue dynamics are primarily tender and procurement driven, with net pricing pressure from contract competition.
• Financial trajectory risk is concentrated in formulary retention, tender award outcomes, and authorized equivalent substitution rather than in retail demand.
• Exclusivity impact is geography-specific and often manifests commercially through tender-panel decisions that occur before or independent of full patent expiry.
• The strongest leading indicators are procurement contract renewals, supplier panel changes, and supply reliability signals that drive account switching.

FAQs

1. How do iodinated contrast media tender awards typically change market share month-to-month?
2. What factors most influence hospital formulary selection for contrast agents besides list price?
3. How can supply disruptions create persistent revenue loss even after shortages end?
4. What is the typical pattern of price compression after generic or authorized equivalents enter contrast media markets?
5. How do pack size, strength, and device compatibility affect contracting decisions for contrast products?

References

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