IOPAMIDOL-370 Drug Patent Profile

When do Iopamidol-370 patents expire, and what generic alternatives are available?

Iopamidol-370 is a drug marketed by Cook Imaging, Fresenius Kabi Usa, and Hospira. and is included in five NDAs.

The generic ingredient in IOPAMIDOL-370 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-370

A generic version of IOPAMIDOL-370 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for IOPAMIDOL-370

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	26
Patent Applications:	4,196
DailyMed Link:	IOPAMIDOL-370 at DailyMed

Recent Clinical Trials for IOPAMIDOL-370

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

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

See all IOPAMIDOL-370 clinical trials

US Patents and Regulatory Information for IOPAMIDOL-370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cook Imaging	IOPAMIDOL-370	iopamidol	INJECTABLE;INJECTION	074881-004	Jul 28, 2000		DISCN	No	No
Hospira	IOPAMIDOL-370	iopamidol	INJECTABLE;INJECTION	075005-003	Feb 24, 1998		DISCN	No	No
Fresenius Kabi Usa	IOPAMIDOL-370	iopamidol	INJECTABLE;INJECTION	074679-003	Apr 2, 1997		DISCN	No	No
Hospira	IOPAMIDOL-370	iopamidol	INJECTABLE;INJECTION	074898-004	Dec 30, 1997		DISCN	No	No
Hospira	IOPAMIDOL-370 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074636-004	Dec 30, 1997		DISCN	No	No

Iopamidol-370 Market Dynamics, Competition, Exclusivity, and Financial Trajectory

Last updated: November 2, 2026

Iopamidol-370 is a high-concentration, nonionic, low-osmolar iodinated contrast medium used primarily for contrast-enhanced CT, angiography, and intravenous urography. In the United States, the principal branded product is Isovue-370, marketed by Bracco Diagnostics. Its commercial profile is mature: clinical demand is recurring, patent barriers are largely historical, and pricing depends more on hospital contracts, supply reliability, imaging volume, and manufacturing capacity than on exclusivity.

Standalone revenue for Iopamidol-370 is not publicly disclosed. Bracco Diagnostics is part of privately held Bracco Group, which does not report product-level sales for Isovue-370. The financial trajectory therefore must be assessed through market structure, procedure demand, competitive pricing, product availability, and Bracco’s broader contrast-media business rather than a verified molecule-specific revenue series.

What is Iopamidol-370 and how is it used?

Iopamidol-370 is an injectable formulation containing 370 mg of organically bound iodine per milliliter. It is a nonionic, water-soluble contrast agent.

Attribute	Iopamidol-370
Active ingredient	Iopamidol
Iodine concentration	370 mg/mL
Drug class	Nonionic, low-osmolar iodinated contrast medium
Primary brand	Isovue-370
U.S. marketing company	Bracco Diagnostics Inc.
Main applications	CT enhancement, cerebral and peripheral angiography, coronary angiography, intravenous digital subtraction angiography
Route	Intravenous or intra-arterial injection
Regulatory category	Prescription drug
Product type	Small-molecule sterile injectable
Major competitors	Iohexol, iopromide, ioversol, iodixanol

The 370 mg/mL concentration is used when high iodine delivery is required. Hospitals select concentration based on imaging protocol, patient characteristics, injector settings, renal-risk policies, and institutional purchasing arrangements.

The FDA labeling for Isovue-370 identifies use in adults for intra-arterial digital subtraction angiography and intravenous contrast-enhanced examinations, including CT imaging and intravenous digital subtraction angiography. The label also includes warnings involving hypersensitivity reactions, acute kidney injury, thyroid dysfunction, extravasation, and cardiovascular or neurologic adverse reactions (U.S. Food and Drug Administration [FDA], 2023).

What is the FDA regulatory status of Iopamidol-370?

Iopamidol-370 is an FDA-approved product marketed under the Isovue brand. The product is associated with Bracco Diagnostics’ original U.S. approval for iopamidol injection products.

Regulatory item	Status
FDA-approved product	Isovue-370
NDA holder	Bracco Diagnostics Inc.
Dosage form	Injection
Strength	370 mg iodine/mL
FDA pathway	Original NDA
Regulatory category	Prescription injectable contrast agent
Biosimilar pathway	Not applicable
Therapeutic equivalence issue	Depends on the specific approved product and application

Iopamidol is a synthetic small molecule, not a biologic. Biosimilar competition is therefore irrelevant. Competitive entry would occur through an abbreviated new drug application, a suitability pathway where applicable, or a full NDA, subject to FDA requirements for sterile injectable manufacturing, quality, labeling, and clinical comparability.

When did Iopamidol-370 lose exclusivity?

The original composition and product patents for iopamidol were filed decades ago and are not the current source of commercial protection. Any original patent exclusivity associated with iopamidol has expired. The product’s continuing commercial position is based on brand recognition, established hospital use, manufacturing scale, regulatory history, and supply-chain execution.

Iopamidol-370 does not have the exclusivity profile of a recently approved specialty drug. Its commercial lifecycle is mature, and the relevant barriers are operational rather than patent-based.

What is the Orange Book status of Isovue-370?

The FDA Orange Book is the primary U.S. source for approved drug products, patent listings, and generic therapeutic-equivalence information. Isovue-370 should be evaluated by its specific NDA and product listing because Orange Book status can vary by dosage form, strength, and approved application.

No commercially significant, unexpired composition-of-matter patent barrier is associated with the mature iopamidol-370 product. Any remaining listed protection would need to be checked against the current FDA Orange Book entry and the specific proposed generic product.

For market-entry analysis, an applicant should distinguish among:

1. Original iopamidol compound patents, which are historical.
2. Product or formulation patents, if listed for a particular presentation.
3. Manufacturing or process patents, which may not appear in the Orange Book.
4. Method-of-use patents, which could affect labeling but are less likely to create broad protection for a mature contrast agent.

How many patents protect Iopamidol-370?

No active patent estate is known to provide broad, commercially meaningful exclusivity for iopamidol-370 in the United States. The product’s historic patent protection has expired or become commercially immaterial.

The practical IP risk is therefore lower than the regulatory and manufacturing risk. A generic applicant would still need to conduct a current freedom-to-operate review covering:

• Sterile injectable formulation and container closure systems.
• Manufacturing processes and impurity controls.
• Device compatibility and injector interfaces.
• Labeling claims and use-specific indications.
• Foreign patents in markets where patent rights may differ.
• Trade secrets involving yield, purification, sterilization, or filling.

Which companies compete with Iopamidol-370?

Iopamidol-370 competes within the broader market for iodinated contrast media rather than only against other iopamidol products.

Competitor	Active ingredient	Representative brand	Principal company
Iopamidol	Iopamidol	Isovue	Bracco
Iohexol	Iohexol	Omnipaque	GE HealthCare
Iopromide	Iopromide	Ultravist	Bayer
Ioversol	Ioversol	Optiray	Guerbet
Iodixanol	Iodixanol	Visipaque	GE HealthCare
Ioxilan	Ioxilan	Oxilan	Generic or regional suppliers

The closest commercial competitors are Omnipaque, Ultravist, Optiray, and Visipaque. Hospital pharmacy committees often evaluate these products as clinically substitutable within protocol limits. The decision is shaped by:

• Contract price.
• Supply continuity.
• Iodine concentration.
• Volume discounts.
• Injector compatibility.
• Clinical preference.
• Existing formulary protocols.
• Adverse-event experience.
• Vendor service and distribution.

Iopamidol-370 is not protected by a unique clinical mechanism. Its competitive advantage is execution within a mature hospital procurement market.

What drives demand for Iopamidol-370?

Demand is linked to imaging and interventional procedure volumes. The principal drivers are:

CT and angiography utilization

Higher CT volumes increase demand for iodinated contrast. Cardiovascular imaging, emergency medicine, oncology staging, vascular studies, and interventional radiology are significant demand centers.

Hospital purchasing behavior

Hospitals generally buy contrast media through group purchasing organizations, regional contracts, or direct manufacturer arrangements. Contracts can create meaningful switching costs even after patent expiry.

Product shortages

Contrast media shortages can rapidly alter market shares. The 2022 Shanghai COVID-19 lockdown disrupted GE HealthCare’s production of iodinated contrast media, creating supply pressure in the United States and prompting conservation measures, temporary substitution, and procurement changes (FDA, 2022).

The episode demonstrated that manufacturing geography and inventory resilience can affect revenue more immediately than patent status.

Renal and safety protocols

Iopamidol competes with other low-osmolar agents on safety, workflow, and institutional experience. Product selection is affected by protocols for patients with chronic kidney disease, diabetes, cardiovascular disease, and prior contrast reactions. Clinical guidelines do not generally make iopamidol-370 an exclusive choice across these populations.

What is the financial trajectory for Iopamidol-370?

A verified product-level revenue trajectory is unavailable because Bracco does not publicly report Isovue-370 sales separately. The most supportable financial assessment is qualitative.

Period	Financial interpretation
Launch and early commercialization	Revenue supported by original product differentiation and branded adoption
Patent-expiry period	Pricing pressure increased as the product moved into a mature contrast-media category
Mature market	Revenue depends on procedure volumes, contracts, supply reliability, and portfolio retention
Shortage periods	Potential volume and share gains for suppliers with available inventory
Long term	Likely stable or volume-sensitive revenue, with ongoing price pressure and limited product-led expansion

Iopamidol-370 is likely a cash-generating mature product rather than a high-growth pharmaceutical asset. Its economics have several characteristics:

• Low research-and-development intensity compared with novel drugs.
• High importance of sterile manufacturing utilization.
• Moderate exposure to hospital price negotiations.
• Recurring demand from diagnostic procedures.
• Limited opportunity for premium pricing based on molecule differentiation.
• Material risk from supply interruptions and quality events.
• Revenue resilience from established clinical use.

Bracco’s broader contrast-media franchise benefits from portfolio breadth across computed tomography, magnetic resonance imaging, and interventional imaging. Product-level financial performance for Isovue-370 cannot be separated from that portfolio using publicly reported Bracco Group disclosures.

What generic entry risks exist for Iopamidol-370?

Generic entry risk is technically feasible but commercially mixed.

Regulatory risk

Sterile injectable products require validated aseptic processing, container-closure integrity, particulate control, endotoxin control, stability data, and reliable commercial-scale manufacturing. FDA approval alone does not ensure hospital adoption.

Manufacturing risk

Iopamidol-370 requires high-volume sterile production and consistent control of iodine concentration, osmolality, pH, impurities, and degradation products. A manufacturer may face more risk from batch failure or supply interruption than from patent litigation.

Commercial risk

A generic entrant would compete against established brands and other contrast agents. Hospital contracts can make market penetration difficult without a price advantage, supply guarantee, or national distribution network.

Litigation risk

A Paragraph IV challenge would be less likely to target a foundational patent because the original patent estate is historical. Any dispute would more likely involve a later formulation, manufacturing, device, or labeling patent, if such rights remain enforceable and listed.

What patent litigation and settlement agreements affect Iopamidol-370?

No major current U.S. patent litigation or settlement agreement is publicly associated with the mature Isovue-370 product that materially changes its market outlook.

The absence of prominent litigation is consistent with the product’s age and the lack of a broad active patent barrier. Generic applicants would still need to review current federal court dockets, FDA patent listings, and non-Orange Book process rights before launch.

How does Iopamidol-370 compare with competing contrast agents?

Factor	Iopamidol-370	Iohexol	Iopromide	Iodixanol
Osmolality class	Low-osmolar	Low-osmolar	Low-osmolar	Iso-osmolar
Main commercial brand	Isovue	Omnipaque	Ultravist	Visipaque
Primary competitive basis	Established use and supply	Scale and broad use	Brand and global presence	Iso-osmolar positioning
Patent-driven advantage	None material	Mature	Mature	Mature
Key risk	Price and supply pressure	Supply and contract concentration	Hospital substitution	Higher acquisition cost in some settings
Biosimilar relevance	None	None	None	None

Iodixanol may command a different economic position because it is iso-osmolar and often positioned for selected high-risk patients, but it is not a direct one-for-one replacement in every protocol. Iohexol is generally the strongest broad-market comparator because of its extensive hospital use and large commercial footprint.

What generic launch scenarios are plausible?

The most plausible scenarios are:

1. Continued branded and multi-source competition with gradual price erosion.
2. Regional generic entry driven by procurement contracts.
3. Temporary share shifts during supply disruptions.
4. Limited premium retention for products with dependable supply and strong distribution.
5. Increased hospital substitution among high-concentration iodinated agents.

A generic entrant could gain share without establishing clinical superiority if it offers reliable availability, competitive pricing, and compatibility with existing imaging workflows.

What is the geographic coverage of Iopamidol-370?

Iopamidol products are marketed internationally under Bracco’s Isovue or equivalent regional brand names, subject to country-specific registrations, labeling, and distribution arrangements. The commercial opportunity is strongest in markets with high CT and angiography utilization, including the United States, Western Europe, Japan, and other developed healthcare systems.

Geographic revenue is affected by:

• National reimbursement.
• Hospital procurement systems.
• Local manufacturing.
• Import requirements.
• Contrast-media shortages.
• Regulatory approval of specific strengths and presentations.

U.S. demand is commercially important because of high imaging utilization and concentrated hospital purchasing. Europe is more fragmented by country and procurement system.

Key Takeaways

• Iopamidol-370 is a mature, nonionic, low-osmolar iodinated contrast medium marketed principally as Isovue-370.
• Original patent exclusivity is no longer the main commercial issue.
• The product has no biosimilar risk because it is a small molecule.
• Generic entry is possible, but sterile manufacturing and hospital contracting create practical barriers.
• Competitive pressure comes from iohexol, iopromide, ioversol, iodixanol, and other iodinated contrast agents.
• Demand follows CT, angiography, emergency imaging, oncology, and interventional procedure volumes.
• Supply reliability can shift market share quickly, as shown by the 2022 contrast-media shortage.
• Bracco does not publicly disclose product-level Isovue-370 revenue, so a precise financial trajectory cannot be calculated.
• The product is best characterized as a mature, recurring-revenue pharmaceutical with limited pricing power and meaningful manufacturing exposure.

FAQs

Is Iopamidol-370 the same as Isovue-370?

Yes. Isovue-370 is the principal U.S. branded product containing iopamidol at 370 mg iodine per milliliter.

Is Iopamidol-370 a generic drug?

Iopamidol is an active pharmaceutical ingredient, while Isovue-370 is the branded finished product. Generic status depends on the specific FDA-approved product and application, not only on the active ingredient name.

Is Iopamidol-370 safer than iodixanol?

Neither product is universally safer for every patient. Clinical selection depends on renal function, prior reactions, procedure type, iodine dose, institutional protocol, and physician judgment.

Can hospitals substitute iohexol for Iopamidol-370?

Hospitals may substitute products under approved imaging protocols, but concentration, dose, injector settings, procedure requirements, and institutional policies must be considered.

Does Iopamidol-370 have patent protection outside the United States?

Original compound and product patents are generally historical, but patent status is jurisdiction-specific. Country-level freedom-to-operate analysis remains necessary for manufacturing and commercialization decisions.

References

1. Bracco Group. (2023). Annual report and corporate information. https://www.bracco.com
2. Bracco Diagnostics Inc. (2023). Isovue-370 prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov
3. U.S. Food and Drug Administration. (2022). Iodinated contrast media supply disruption. https://www.fda.gov
4. U.S. Food and Drug Administration. (2023). Drugs@FDA: FDA-approved drug products. https://www.accessdata.fda.gov/scripts/cder/daf/
5. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugsatfda
6. American College of Radiology. (2023). ACR manual on contrast media. https://www.acr.org/Clinical-Resources/Contrast-Manual