IOPAMIDOL-300 Drug Patent Profile

Which patents cover Iopamidol-300, and when can generic versions of Iopamidol-300 launch?

Iopamidol-300 is a drug marketed by Abbvie, Cook Imaging, Fresenius Kabi Usa, and Hospira. and is included in seven NDAs.

The generic ingredient in IOPAMIDOL-300 is iopamidol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iopamidol-300

A generic version of IOPAMIDOL-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for IOPAMIDOL-300

US Patents:	0
Applicants:	4
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	26
Patent Applications:	4,562
DailyMed Link:	IOPAMIDOL-300 at DailyMed

Recent Clinical Trials for IOPAMIDOL-300

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Masonic Cancer Center, University of Minnesota	PHASE2
Army Medical Center of PLA	N/A

See all IOPAMIDOL-300 clinical trials

US Patents and Regulatory Information for IOPAMIDOL-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074638-001	Apr 30, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074637-001	Apr 3, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074898-003	Dec 30, 1997		DISCN	No	No
Cook Imaging	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074881-003	Jul 28, 2000		DISCN	No	No
Fresenius Kabi Usa	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074679-002	Apr 2, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074636-003	Dec 30, 1997		DISCN	No	No

Iopamidol-300 Market Dynamics, Patent Status, Competition, and Financial Trajectory

Last updated: October 29, 2026

Iopamidol-300 is an established, off-patent iodinated contrast medium sold primarily as Isovue-300 by Bracco Diagnostics and through generic or institutional channels. Its commercial trajectory is driven by CT and angiography procedure volumes, hospital purchasing contracts, manufacturing reliability, and contrast-media shortages rather than by patent exclusivity. Product-level revenue is not publicly disclosed, so the financial outlook is best assessed through procedure demand, pricing pressure, supplier concentration, and Bracco’s broader imaging business.

What is Iopamidol-300 and how is it used?

Iopamidol-300 is an injectable, nonionic, low-osmolar iodinated contrast agent containing 300 mg of organically bound iodine per mL. It is used to enhance imaging in computed tomography, angiography, digital subtraction angiography, and other radiographic procedures.

The principal branded product is Isovue-300, manufactured by Bracco Diagnostics Inc. The U.S. product was approved under New Drug Application No. 018264. The FDA label covers several intravascular imaging uses, with dosing determined by the procedure, patient characteristics, and imaging protocol. [1]

Attribute	Iopamidol-300
Active ingredient	Iopamidol
Concentration	300 mg iodine/mL
Drug class	Nonionic, low-osmolar iodinated contrast media
Main dosage form	Sterile injectable solution
Principal U.S. brand	Isovue-300
Primary manufacturer	Bracco Diagnostics
Main channels	Hospitals, radiology centers, outpatient imaging networks
Principal uses	CT, angiography, vascular imaging
Regulatory pathway for generics	Abbreviated New Drug Application
Patent status	Mature, off-patent product
Biosimilar relevance	None

Iopamidol-300 competes clinically with iohexol 300, iopromide 300, ioversol 320, and other low-osmolar iodinated contrast agents. In many routine procedures, hospitals can substitute among products if imaging protocols, formulary approvals, supply availability, and equipment requirements permit.

How large is the Iopamidol-300 market?

No authoritative public source reports global or U.S. revenue specifically for Iopamidol-300. Bracco is privately held and does not provide detailed product-level sales for Isovue-300. Public market research reports generally aggregate iodinated contrast media by class, region, or manufacturer rather than isolate a single concentration.

The addressable market is tied to the broader diagnostic imaging market. Demand is supported by:

• Growth in CT utilization.
• Expansion of outpatient imaging.
• Vascular and interventional radiology procedures.
• Aging populations with higher rates of cardiovascular disease, cancer, and neurological conditions.
• Continued use of contrast-enhanced CT in emergency and inpatient care.

Demand is constrained by:

• Radiation-reduction protocols and selective use of contrast.
• Renal-risk screening and hydration requirements.
• Hospital budget controls.
• Substitution between iodinated contrast products.
• Generic and tender-based purchasing.
• Periodic shortages that shift market share among suppliers.

Iopamidol-300 is therefore a volume-driven mature pharmaceutical product. Revenue growth depends more on procedure growth and supply capture than on increased unit pricing.

What is the financial trajectory for Iopamidol-300?

The financial trajectory is likely to show stable or modest unit-volume growth, offset by price erosion and procurement pressure.

Financial driver	Expected effect on Iopamidol-300
CT and angiography volume	Positive
Generic competition	Negative for price
Hospital group purchasing	Negative for price and margin
Product shortages affecting rivals	Positive for temporary volume and pricing
Manufacturing costs	Negative when iodine, energy, labor, or sterile-fill costs rise
Brand loyalty	Limited in routine hospital use
Regulatory barriers	Support incumbent suppliers
Product differentiation	Low

Bracco’s economics are supported by scale, established hospital relationships, manufacturing know-how, and a broad contrast portfolio. Iopamidol-300 is likely more valuable as part of that portfolio than as a standalone high-margin asset. Hospitals often purchase several concentrations and formulations from the same supplier, allowing a manufacturer to use portfolio contracting across CT, angiography, and other imaging applications.

A reasonable commercial interpretation is:

1. Near-term revenue: Stable, with episodic increases during competitor shortages.
2. Medium-term revenue: Low single-digit volume growth may be offset by price erosion.
3. Long-term margin: Dependent on manufacturing efficiency, supply reliability, and portfolio bundling.
4. Standalone product value: Limited relative to newer contrast technologies or patented drug products.
5. Strategic value: Meaningful as a recurring hospital product with regulatory and manufacturing barriers to entry.

There is no reliable public basis for assigning a standalone annual revenue figure to Iopamidol-300.

When does Iopamidol-300 lose exclusivity?

Iopamidol-300 lost meaningful market exclusivity decades ago. Isovue was approved in the 1980s, and the active ingredient is now a mature generic product. Any original composition, formulation, or use patents would have expired well before the current market period.

The commercial protection remaining today is operational rather than patent-based:

• FDA-approved manufacturing capacity.
• Validated sterile filling lines.
• Drug Master Files and supplier qualification.
• Hospital formulary status.
• Contracting relationships.
• Reliable inventory and distribution.
• Experience with pharmacovigilance and post-market quality requirements.

For an established injectable, these barriers can preserve market share even after patent expiry. They do not create the pricing power associated with active patent protection.

What patents protect Iopamidol-300?

No material active U.S. patent estate is generally associated with the original iopamidol-300 product. The relevant product is listed as an approved drug rather than a patent-protected innovative medicine.

Patent category	Current commercial relevance
Original iopamidol composition patents	Expired
Original Isovue product patents	Expired or commercially irrelevant
Method-of-use patents	No material exclusivity generally expected
Formulation patents	No known blocking estate for routine iopamidol-300
Manufacturing patents	May exist but are unlikely to block ordinary generic manufacture
Device patents	Limited relevance for standard vials, bottles, or syringes
Orange Book-listed patents	No material active listing expected to prevent generic competition

The main intellectual-property risk is not infringement of an active foundational patent. It is the possibility that a manufacturer uses a protected manufacturing process, proprietary container system, or a separately protected delivery configuration. Those risks are narrower than the composition and formulation patent risks applicable to newer drugs.

What is the Orange Book status of Isovue-300?

Isovue-300 is associated with FDA-approved iopamidol injection products, including NDA No. 018264. The Orange Book is relevant for identifying the reference product and any listed patents or exclusivities. For a product of this age, the practical Orange Book position is that no remaining innovative-drug exclusivity should materially restrict ANDA competition.

Orange Book issue	Iopamidol-300 assessment
Reference listed drug	Isovue-300 / iopamidol injection
NDA	018264
New chemical entity exclusivity	Expired
Orphan exclusivity	Not applicable
Pediatric exclusivity	Not commercially material
Active composition patent barrier	Not expected
ANDA pathway	Available
Current legal moat	Manufacturing and supply execution

Which companies compete with Iopamidol-300?

Iopamidol-300 competes with both the same molecule and other iodinated contrast agents.

Direct and near-direct competitors

Product	Active ingredient	Company or supplier category
Isovue-300	Iopamidol	Bracco
Omnipaque 300	Iohexol	GE HealthCare
Ultravist 300	Iopromide	Bayer
Optiray 320	Ioversol	Guerbet
Generic iopamidol injection	Iopamidol	Generic and institutional suppliers
Other low-osmolar agents	Various	Multiple manufacturers

Competitive substitution is strongest in routine CT imaging. It is narrower in certain angiographic procedures because radiologists and hospitals may standardize protocols, injector settings, vial sizes, and workflow around a particular product.

GE HealthCare has significant strength in contrast media because of its Omnipaque franchise, global manufacturing network, and installed base across imaging systems. Bayer and Guerbet also compete through branded products and hospital contracts. Bracco’s advantage is its established Isovue franchise and broad diagnostic imaging portfolio.

What generic entry risks exist for Iopamidol-300?

Generic entry risk is high from a legal perspective and moderate from a commercial perspective.

The legal barrier is low because the original product is off patent and an ANDA pathway is available. The commercial barrier is higher because injectable contrast media require:

• Sterile manufacturing.
• Validated aseptic processing.
• Consistent iodine concentration.
• Tight control of particulate and endotoxin levels.
• Reliable container-closure systems.
• Large-scale hospital distribution.
• FDA inspection readiness.
• Supply continuity during demand surges.

A new entrant may obtain approval yet struggle to gain share because hospitals prioritize uninterrupted supply, validated protocols, and competitive contract pricing. Contrast media are also subject to tendering and group-purchasing agreements, which can make scale important from the first commercial year.

Have companies filed Paragraph IV challenges against Isovue-300?

Paragraph IV litigation is not a central current risk for Iopamidol-300. The product’s foundational exclusivity expired long ago, reducing the incentive for a conventional patent challenge against the original Isovue-300 franchise.

Any recent ANDA litigation would more likely involve:

• A later-added formulation.
• A container or delivery system.
• A manufacturing process.
• A separate concentration or presentation.
• A patent unrelated to the basic iopamidol-300 composition.

No material, current Paragraph IV dispute is generally associated with the core iopamidol-300 product based on its mature regulatory and patent position.

What formulation patents protect Iopamidol-300?

The standard formulation is an aqueous injectable solution of iopamidol with excipients and pH control. The basic 300 mg iodine/mL formulation is not expected to have meaningful remaining patent protection.

Potentially differentiated areas include:

• Prefilled syringes.
• Polymer or specialty container systems.
• Automated injector compatibility.
• Low-waste packaging.
• High-volume bags.
• Ready-to-use institutional presentations.
• Stability improvements.
• Specialized administration systems.

These products may create commercial differentiation without materially extending protection for the core drug. Any patent analysis must distinguish the active ingredient and solution from the container, device, or manufacturing process.

How do manufacturing and supply constraints affect the market?

Manufacturing reliability is one of the strongest competitive variables. Iopamidol-300 is a sterile injectable, and production interruptions can affect hospitals quickly because imaging departments depend on predictable inventory.

Key supply-chain risks include:

• Iodinated raw-material availability.
• Sterile-filling capacity.
• Glass and polymer container supply.
• Quality-control release times.
• Transportation and warehouse constraints.
• Concentration-specific inventory imbalances.
• Regulatory inspections or remediation.
• Sudden shifts in demand after competitor shortages.

The 2022 global contrast-media disruptions demonstrated the market impact of concentrated manufacturing networks and hospital inventory vulnerability. The FDA and professional radiology organizations issued guidance during contrast shortages, including conservation and prioritization measures. [2, 3]

For Iopamidol-300, supply reliability can temporarily produce more value than brand premium. A supplier with available inventory may win emergency orders, new hospital contracts, or conversion opportunities from a rival product. Those gains may reverse when normal supply returns.

What FDA regulatory issues affect Iopamidol-300?

The principal FDA risks are quality and supply risks rather than approval risk. Relevant controls include:

• Current Good Manufacturing Practice compliance.
• Sterility assurance.
• Endotoxin control.
• Container-closure integrity.
• Accurate iodine concentration.
• Labeling for intravascular administration.
• Adverse-event monitoring.
• Shortage reporting and supply communication.

Iopamidol products also carry clinically important renal, hypersensitivity, extravasation, and thyroid-related warnings. These risks affect institutional protocols and product selection, but they are class-wide considerations rather than a unique patent disadvantage for iopamidol. [1]

What is the litigation and settlement outlook?

The litigation profile is low compared with patented oncology, immunology, or specialty drugs. There is no apparent basis for a major patent-settlement-driven delay in generic entry for the core iopamidol-300 product.

Potential disputes are more likely to involve:

• Product liability.
• Manufacturing defects.
• FDA inspection findings.
• Supply-contract performance.
• Hospital procurement contracts.
• Trade-secret claims involving manufacturing.
• Device or packaging patents.

Because the core product is mature, settlement economics are less likely to support a traditional “first-filer versus brand” Hatch-Waxman settlement structure.

How does Iopamidol-300 compare with competing contrast agents?

Factor	Iopamidol-300	Iohexol 300	Iopromide 300	Ioversol 320
Brand example	Isovue-300	Omnipaque 300	Ultravist 300	Optiray 320
Patent position	Mature/off patent	Mature/off patent	Mature/off patent	Mature/off patent
Main commercial advantage	Established Isovue supply and protocols	Large global franchise	Bayer portfolio and hospital presence	Established low-osmolar alternative
Switching risk	Low to moderate	Low to moderate	Low to moderate	Low to moderate
Price pressure	High	High	High	High
Shortage sensitivity	High	High	High	High
Biosimilar exposure	None	None	None	None

Clinical equivalence is not absolute in operational terms. Hospitals may standardize contrast choice based on injector compatibility, concentration, adverse-event experience, procurement agreements, and availability.

What is the outlook for generic launch scenarios?

Base case

Existing suppliers retain most demand, with modest volume growth and continued price pressure. Bracco maintains Isovue-300 through hospital contracts and portfolio selling.

Upside case

A shortage affecting iohexol, iopromide, or ioversol creates temporary conversion to iopamidol-300. Bracco gains short-term volume and may secure new accounts.

Downside case

Hospitals consolidate contracts around lower-cost generic suppliers or a rival with stronger supply capacity. Unit prices decline, and Bracco’s share falls despite stable procedure demand.

Severe downside case

A manufacturing or quality event interrupts supply. Hospitals rapidly qualify alternatives, creating permanent share loss even after production resumes.

What is the geographic market position?

The United States is commercially important because of its large CT and hospital market, but demand is global. Europe, Japan, China, and other developed markets have established use of nonionic iodinated contrast agents.

Geographic performance depends on:

• National reimbursement.
• Hospital tendering.
• Local registration requirements.
• Domestic manufacturing preferences.
• Import controls.
• Distributor networks.
• Contrast-media usage per capita.

China and other Asian markets may offer volume growth, but local competition and pricing controls can limit margins. Developed markets generally provide stable procedure volumes but stronger procurement pressure.

Key Takeaways

• Iopamidol-300 is a mature, off-patent iodinated contrast agent.
• Isovue-300 is the principal U.S. branded reference product associated with Bracco Diagnostics.
• No meaningful remaining composition, formulation, or method-of-use exclusivity is expected to block generic competition.
• Product-level revenue is not publicly disclosed, preventing a reliable standalone sales forecast.
• Financial performance depends on CT and angiography volumes, hospital contracting, supply reliability, and manufacturing costs.
• The product has high legal generic-entry exposure but meaningful operational barriers related to sterile manufacturing and hospital qualification.
• The strongest commercial opportunities arise during competitor shortages or supply disruptions.
• The main competitive products are iohexol 300, iopromide 300, and ioversol 320.
• Biosimilar risk is irrelevant because iopamidol is a small-molecule contrast agent.
• Long-term pricing is likely to remain under pressure, while demand should track diagnostic imaging activity.

FAQs

Is Iopamidol-300 a generic drug?

Iopamidol-300 is an established active ingredient available in branded and generic injectable products. Isovue-300 is the principal branded U.S. reference product.

Is Isovue-300 still patent protected?

The original patent-based exclusivity for Isovue-300 has expired. Current commercial protection comes from manufacturing scale, hospital contracts, product reliability, and regulatory compliance.

Can hospitals substitute iohexol 300 for iopamidol-300?

Hospitals can often substitute among low-osmolar iodinated contrast agents, but substitution requires review of protocols, injector settings, formulary requirements, clinical practice, and supply conditions.

Does Iopamidol-300 have biosimilar competition?

No. Biosimilar regulation applies to biologic products. Iopamidol-300 is a small-molecule injectable contrast agent and competes through generic drug pathways.

What is the largest financial risk for Iopamidol-300?

The largest risk is sustained price erosion from hospital tenders and generic competition. The largest short-term opportunity is capturing demand during shortages of competing contrast agents.

References

1. U.S. Food and Drug Administration. (n.d.). Isovue-300 (iopamidol injection) prescribing information and Drugs@FDA records, NDA 018264. https://www.accessdata.fda.gov/scripts/cder/daf/

2. U.S. Food and Drug Administration. (2022). FDA statement on the shortage of iodinated contrast media. https://www.fda.gov/drugs/drug-safety-and-availability

3. American College of Radiology. (2022). ACR manual on contrast media and guidance related to iodinated contrast media shortages. https://www.acr.org/Clinical-Resources/Contrast-Manual

4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

5. Bracco. (n.d.). Diagnostic imaging products and corporate information. https://www.bracco.com