IOPAMIDOL-370 IN PLASTIC CONTAINER Drug Patent Profile

When do Iopamidol-370 In Plastic Container patents expire, and when can generic versions of Iopamidol-370 In Plastic Container launch?

Iopamidol-370 In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in IOPAMIDOL-370 IN PLASTIC CONTAINER 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 In Plastic Container

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

Summary for IOPAMIDOL-370 IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	26
Patent Applications:	4,643
DailyMed Link:	IOPAMIDOL-370 IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for IOPAMIDOL-370 IN PLASTIC CONTAINER

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

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

See all IOPAMIDOL-370 IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for IOPAMIDOL-370 IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	IOPAMIDOL-370 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074636-004	Dec 30, 1997		DISCN	No	No

Iopamidol-370 in Plastic Container: Market Dynamics, Patent Position and Financial Trajectory

Last updated: September 25, 2026

Iopamidol-370 injection is a mature, genericized iodinated contrast medium used primarily for contrast-enhanced computed tomography, angiography and selected intravenous diagnostic procedures. The product is associated in the United States with Bracco Diagnostics’ Isovue-370 presentation, including single-dose plastic containers. Its commercial outlook is driven by CT procedure volumes, hospital purchasing contracts, supply reliability and price competition rather than patent exclusivity.

Product-level revenue is not publicly disclosed. Bracco Diagnostics is privately held, and available public filings do not separately report sales for iopamidol-370, Isovue-370 or the plastic-container presentation. Financial analysis therefore relies on market structure, competitor activity, contrast-media supply conditions and parent-company disclosures.

What is iopamidol-370 in a plastic container?

Iopamidol-370 is a nonionic, low-osmolar, water-soluble iodinated contrast injection containing 370 mg of organically bound iodine per milliliter. It is supplied for intravascular administration and is used to enhance radiographic visualization during CT and angiographic procedures.

Attribute	Product profile
Active ingredient	Iopamidol
Iodine concentration	370 mg iodine/mL
Dosage form	Sterile injectable solution
Container	Single-dose plastic container presentation
Primary use	Contrast enhancement for CT and angiography
Drug class	Nonionic, low-osmolar iodinated contrast medium
U.S. commercial association	Isovue-370, Bracco Diagnostics
FDA pathway	New drug application and subsequent generic competition
Biosimilar exposure	None; iopamidol is a small molecule
Primary purchasers	Hospitals, imaging centers, radiology departments and group purchasing organizations

The plastic container is a delivery and logistics feature, not a distinct active pharmaceutical ingredient. Its commercial value relates to handling, break resistance, storage, filling efficiency and compatibility with automated contrast injectors.

What is the FDA regulatory status of iopamidol-370?

Iopamidol-370 is an FDA-approved prescription injectable contrast agent. The FDA-approved labeling covers intravascular use and includes warnings relating to hypersensitivity reactions, acute kidney injury risk, extravasation, thyroid effects and other adverse reactions associated with iodinated contrast media.[1]

The product is administered in controlled clinical settings. Its purchasing cycle is tied to radiology procedure volume and institutional formularies rather than direct-to-consumer demand.

What are the main FDA-approved uses?

Iopamidol-370 labeling supports use in procedures such as:

• Contrast-enhanced CT examinations of the head and body.
• Digital subtraction angiography.
• Intra-arterial and intravenous angiographic procedures.
• Other vascular imaging applications identified in the prescribing information.

Use is subject to patient-specific assessment of renal function, allergy history, hydration status and the clinical need for contrast enhancement.

Is iopamidol-370 a biologic or biosimilar product?

No. Iopamidol is a chemically synthesized small molecule. Biosimilar approval pathways under the Public Health Service Act do not apply. Competitive entry occurs through abbreviated new drug applications, authorized generics, branded generics and contract supply arrangements.

What patents protect iopamidol-370 and when did exclusivity end?

The core commercial protection for iopamidol-370 has expired. The product was introduced decades ago, and the active ingredient is no longer protected by a meaningful composition-of-matter patent position in the United States.

The commercial patent assessment is therefore:

Protection category	Current significance
Core composition patent	Expired or commercially exhausted
Basic injectable formulation	Mature and generally available to competitors
Method-of-use patents	Limited relevance to ordinary labeled imaging use
Container configuration	Potentially protectable in theory, but not a material barrier to standard generic entry
Manufacturing process	May be protected as trade secret or by process patents, but does not block alternative suppliers
Pediatric exclusivity	Not a current commercial factor
New chemical entity exclusivity	Expired
Patent-term extension	No material current effect on market entry

The FDA Orange Book remains the controlling source for listed patents and regulatory exclusivity associated with a specific application.[2] Public product labeling does not establish a current patent barrier capable of preserving monopoly pricing for iopamidol-370.

Are there Paragraph IV challenges to iopamidol-370?

Paragraph IV litigation is not the primary commercial issue for this product. Iopamidol-370 is a mature product with an established generic market, and the key entry barriers are manufacturing, regulatory compliance, sterility assurance, supply qualification and hospital contracting.

Where a generic applicant challenges a listed patent, it must certify that the patent is invalid, unenforceable or will not be infringed. For a mature contrast medium with limited current patent protection, the economic incentive to pursue high-cost patent litigation is lower than for a recently launched branded medicine.

What is the Orange Book status of iopamidol-370?

Iopamidol products are regulated through FDA-approved applications and may appear in the Orange Book under the relevant product application and applicant name. The Orange Book status must be assessed at the application and presentation level because approval holders, strengths, container types and generic applicants can differ.[2]

The commercially relevant point is that Orange Book listing does not itself preserve market exclusivity. A listed patent must remain unexpired and enforceable, and a competing applicant must still obtain FDA approval before launching.

For iopamidol-370, the market is best characterized as post-exclusivity. Regulatory approval, not patent exclusivity, determines whether a supplier can enter.

How strong is the patent estate for iopamidol-370?

The patent estate is weak as a source of pricing power but may remain relevant in three operational areas.

Formulation and container patents

A supplier could seek protection for a specific formulation, container, stopper, overwrap, fill volume, terminal sterilization process or injector-compatible package. These rights would usually protect a defined implementation rather than iopamidol-370 as a molecule.

Plastic-container patents may cover:

• Container geometry.
• Material composition.
• Oxygen or moisture barrier properties.
• Closure systems.
• Port configuration.
• Compatibility with automated injectors.
• Packaging methods that reduce breakage or contamination.

Such rights rarely prevent competitors from selling the same concentration in vials, bottles or alternative plastic systems.

Manufacturing and process rights

Manufacturing know-how can affect product quality and cost. Important process controls include:

• Iopamidol synthesis and impurity removal.
• Sterile filtration and aseptic filling.
• Endotoxin control.
• Container-closure integrity.
• Extractables and leachables testing.
• Long-term stability of the filled plastic container.

These controls can create practical barriers for new entrants even when no enforceable patent blocks market entry. Manufacturing know-how is often protected through confidential information rather than publicly visible patents.

What companies compete with iopamidol-370?

Iopamidol-370 competes within the broader market for iodinated contrast media. The principal alternatives include iohexol, ioversol and iodixanol.

Product	Active ingredient	Major commercial association	Competitive position
Isovue-370	Iopamidol	Bracco Diagnostics	Established low-osmolar contrast agent
Omnipaque	Iohexol	GE HealthCare	Major CT and angiography competitor
Optiray	Ioversol	Guerbet	Established alternative for CT and vascular imaging
Visipaque	Iodixanol	GE HealthCare	Iso-osmolar product with differentiated clinical positioning
Generic iopamidol	Iopamidol	Multiple approved or contracted suppliers	Price-driven substitute where institutionally qualified

The competitive decision is rarely based only on molecule identity. Hospitals evaluate product availability, injector compatibility, iodine concentration, renal-risk protocols, adverse-event experience, contract price, delivery reliability and vendor support.

How do supply shortages affect iopamidol-370?

Supply continuity is a major market driver. Iodinated contrast media manufacturing is concentrated among a limited number of global suppliers, and disruption at a major plant can affect hospitals across multiple countries.

Shortages can result from:

• Manufacturing-site shutdowns.
• Sterility failures.
• Raw-material constraints.
• Transportation disruption.
• Sudden increases in CT and angiography demand.
• Regional allocation policies.
• Limited redundancy for high-volume presentations.

The 2022 global iodinated contrast shortage demonstrated that hospitals can be forced to ration contrast, substitute products, reduce dose, delay imaging or prioritize emergency cases. FDA shortage records and hospital communications should be monitored because they can materially change short-term market share.[3]

For iopamidol-370, supply reliability can temporarily outweigh nominal price differences. A supplier with dependable inventory may gain formulary share even when its list price is not the lowest.

What is the financial trajectory for iopamidol-370?

The product’s financial trajectory is mature and volume-sensitive rather than innovation-driven.

Revenue drivers

Revenue is primarily affected by:

1. CT procedure growth.
2. Angiography and interventional radiology volumes.
3. Hospital contract renewals.
4. Generic price erosion.
5. Product availability.
6. Conversion between competing iodine concentrations.
7. Demand for plastic containers and automated injector-compatible formats.

The aging population and increased use of diagnostic imaging support long-term procedure demand. Cost containment and generic substitution limit unit-price growth.

Revenue constraints

The product faces several structural limits:

• No meaningful remaining molecule-level exclusivity.
• Institutional procurement pressure.
• Group purchasing organization discounts.
• Substitution by iohexol, ioversol and iodixanol.
• Limited product differentiation among low-osmolar agents.
• Exposure to shortages and manufacturing interruptions.
• High regulatory requirements for sterile injectable production.

No public source provides standalone annual revenue, gross margin or EBITDA for iopamidol-370. Bracco’s private ownership limits product-level financial transparency.[4]

Indicative commercial lifecycle

Period	Commercial condition	Financial effect
Launch and early adoption	Branded product and limited alternatives	Higher price and stronger margins
Generic entry	Multiple suppliers qualify	Lower price, broader volume access
Mature competition	Contract-driven purchasing	Stable or declining unit economics
Supply disruption	Scarcity and allocation	Temporary volume and pricing volatility
Post-shortage normalization	Rebalancing among suppliers	Share depends on reliability and contracts

The base-case trajectory is stable-to-declining revenue per dose, with total sales supported by imaging-volume growth. A supplier can protect revenue through reliable supply, hospital contracts, differentiated packaging and broad portfolio coverage across iodine concentrations.

What generic launch risks exist for iopamidol-370?

Generic entry is technically feasible but not frictionless. The principal risks are operational and regulatory.

Generic manufacturers

Potential competitors include established manufacturers of sterile injectable products, contrast-media specialists and companies supplying hospital generic portfolios. The relevant competitive advantage is not simply FDA approval. It is the ability to:

• Produce at commercial scale.
• Maintain sterile manufacturing compliance.
• Support multiple package sizes.
• Meet hospital qualification requirements.
• Integrate with injector systems.
• Maintain inventory during demand spikes.
• Offer competitive contract pricing.

Launch scenarios

Scenario	Market impact
One additional reliable generic supplier	Moderate price pressure
Several suppliers enter	Stronger discounting and share rotation
Branded supplier maintains shortage-free supply	Slower erosion of branded share
Manufacturing disruption	Temporary price and volume volatility
Hospital conversion to another iodine concentration	Share loss despite stable procedure volume

A generic launch would not need to overcome meaningful composition-patent risk. It would need to satisfy FDA quality requirements and secure hospital and distributor access.

What litigation and settlement issues affect iopamidol-370?

No major current patent-settlement framework is central to the commercial outlook for mature iopamidol-370 presentations. Litigation exposure is more likely to arise from:

• Product-liability claims.
• Contrast-reaction claims.
• Manufacturing defects.
• Sterility or contamination allegations.
• False advertising or comparative promotion.
• Hospital contracting disputes.
• Patent disputes involving specialized packaging or delivery systems.

A settlement involving a specific generic applicant could affect launch timing, but the broader market remains governed by post-exclusivity competition and supply contracts.

How does iopamidol-370 compare with iohexol and iodixanol?

Iopamidol-370 competes most directly with high-iodine-concentration formulations of iohexol and ioversol. Iodixanol has a different osmolarity profile and may command a premium in selected institutional protocols.

Factor	Iopamidol-370	Iohexol	Iodixanol
Main commercial role	Low-osmolar CT and angiography	Broad low-osmolar CT and angiography use	Iso-osmolar differentiated option
Price sensitivity	High	High	Typically higher
Generic pressure	Significant	Significant	Significant but more differentiated
Hospital switching risk	Moderate to high	Moderate to high	Lower where protocol-specific
Key advantage	Established use and supplier familiarity	Broad availability and scale	Clinical positioning tied to osmolarity
Main risk	Commodity pricing and substitution	Competitive contracting	Premium-price pressure

Iopamidol-370’s strongest commercial defense is operational performance: consistent availability, validated packaging, injector compatibility and competitive contracting.

What is the geographic market outlook?

The United States is a large and mature market with strong hospital purchasing discipline. Europe and other developed markets also have substantial demand, but pricing and reimbursement structures vary by country.

Geographic performance depends on:

• National tender systems.
• Hospital procurement groups.
• Local registration requirements.
• Manufacturing-site approvals.
• Import and distribution capacity.
• Public reimbursement of imaging procedures.
• Regional supply shortages.

A supplier with manufacturing redundancy and multi-region regulatory approvals can reduce dependence on any one market. Export restrictions or plant-specific regulatory findings can produce regional shortages even when global capacity is adequate.

Key Takeaways

• Iopamidol-370 is a mature, post-exclusivity iodinated contrast product.
• The U.S. commercial reference is Bracco’s Isovue-370 presentation, including plastic-container formats.
• No biosimilar risk exists because iopamidol is a small molecule.
• Core composition and basic formulation protection do not provide a meaningful current monopoly.
• Product-level revenue is not publicly disclosed.
• Financial performance depends on CT and angiography volumes, hospital contracts, generic pricing and supply reliability.
• The main competitors are iohexol, ioversol and iodixanol products.
• Plastic-container technology can support handling and procurement differentiation but is unlikely to block competing products.
• Manufacturing quality, sterility assurance and supply continuity are more important than patent exclusivity.
• Generic launch risk is primarily commercial and operational, not patent-driven.

FAQs

Is iopamidol-370 the same as Isovue-370?

Iopamidol-370 is the active pharmaceutical product description. Isovue-370 is the branded commercial product associated with Bracco Diagnostics.

Can hospitals substitute iohexol for iopamidol-370?

Hospitals can use alternative iodinated contrast media when clinically appropriate, subject to institutional protocols, physician judgment, patient factors, injector requirements and product availability.

Does the plastic container create a separate drug product?

The plastic container is a presentation and packaging configuration. It does not create a different active ingredient or a separate therapeutic molecule.

Is iopamidol-370 exposed to renal-safety restrictions?

Yes. Iodinated contrast administration requires evaluation of renal function and other patient-specific risks. The FDA label includes warnings and precautions concerning renal injury and hypersensitivity reactions.[1]

What is the most important investment risk for iopamidol-370?

The principal risk is margin erosion from mature generic competition, compounded by hospital purchasing pressure and potential manufacturing or supply interruptions.

References

1. U.S. Food and Drug Administration. (n.d.). Iopamidol injection prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

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

3. U.S. Food and Drug Administration. (n.d.). Drug shortages: Iodinated contrast media. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

4. Bracco Group. (n.d.). Bracco Diagnostics and contrast media portfolio. https://www.bracco.com/