Last Updated: June 12, 2026

IOPAMIDOL-370 Drug Patent Profile


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Which patents cover Iopamidol-370, and when can generic versions of Iopamidol-370 launch?

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 are eleven drug master file entries for this compound. Three 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 27th, 2023.

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Summary for IOPAMIDOL-370
US Patents:0
Applicants:3
NDAs:5

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-370 iopamidol INJECTABLE;INJECTION 075005-003 Feb 24, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa IOPAMIDOL-370 iopamidol INJECTABLE;INJECTION 074679-003 Apr 2, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-370 iopamidol INJECTABLE;INJECTION 074898-004 Dec 30, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-370 IN PLASTIC CONTAINER iopamidol INJECTABLE;INJECTION 074636-004 Dec 30, 1997 DISCN No No ⤷  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

Iopamidol-370 (IOPAMIDOL INJECTION, 370 mg I/mL): Investment Scenario and Fundamentals

Last updated: April 25, 2026

What is Iopamidol-370 and where does it sell?

Iopamidol-370 is a non-ionic, low-osmolar iodinated contrast medium for diagnostic imaging. The “370” label denotes iodine concentration of 370 mg I/mL.

Product form and clinical use

  • IV and intra-arterial (IA) contrast for computed tomography (CT), angiography, and other imaging where iodinated contrast is used.
  • Market pull comes from routine imaging demand in radiology and interventional cardiology/vascular procedures.

Competitive product structure Iopamidol-370 typically competes against:

  • Other iodinated, non-ionic low-osmolar agents (class peers by concentration and route).
  • Generics and private-label equivalents where patent and brand moat are weak.

Demand characteristics

  • Contrast media are used in high-volume diagnostic workflows; volumes track imaging procedure intensity more than new clinical guideline adoption.
  • Uptake is strongly shaped by tendering, formulary placement, stocking economics, and clinical protocol standardization rather than brand-driven preference.

What is the market and adoption pattern for iodinated contrast at 370 mg I/mL?

While pricing varies by geography and tender mechanics, the competitive physics of iodinated contrast are consistent across countries:

Where revenue is concentrated

  • Hospital and imaging centers are the dominant buyers.
  • National procurement tenders and group purchasing organizations set realized pricing.

What drives formulary selection

  • Supply reliability (bulk allocation risk matters in radiology supply chains)
  • Batch consistency and product availability
  • Contract pricing and substitution rules at the pharmacy/infusion level

What does “370” mean commercially

  • Concentration standardization reduces clinician variability and simplifies workflow.
  • Hospitals often standardize on one or two contrast products per imaging service line.

How do patents and exclusivity typically impact iopamidol-370 pricing power?

For legacy iodinated contrast products such as iopamidol, the investment implication is that patent exclusivity historically erodes into generic and authorized-supply competition. The class tends toward:

  • Multiple authorized manufacturers over time
  • High price competition after key patent/authorization windows close
  • Procurement-driven margin compression as substitution becomes routine

Commercial consequence

  • For investors, the dominant question is less about incremental clinical differentiation and more about contract position, supply assurance, and procurement leverage.

What are the core fundamentals for an investment in iopamidol-370?

1) Supply chain reliability is a primary moat

Contrast media are sensitive to:

  • Production capacity constraints
  • Regulatory lot release timelines
  • Global API supply and specialty chemical capacity

For investors, the fundamental indicator is whether the company can consistently meet tender schedules without allocation.

2) Volume stability usually outweighs unit-price upside

Unlike specialty oncology, contrast demand is relatively steady because imaging utilization is routine. The fundamental return driver is:

  • Sustained hospital contracting
  • Retention after tender renewals
  • Ability to defend share against generics

3) Margin profile is procurement-dependent

Because substitution is common, margin scales with:

  • Contract terms and rebate structures
  • Distribution channel economics
  • Manufacturing cost position (API and formulation costs)

4) Liability and pharmacovigilance costs matter

Iopamidol products carry established safety labeling for iodinated contrast use. Ongoing cost impacts come from:

  • Pharmacovigilance operations
  • Medical affairs and risk communication
  • Managing recall and batch deviation risk

What is the competitive landscape and how does it affect expected returns?

Key competitive levers

  • Authorized generic entry and private label expand supply and force pricing down.
  • Tender participation quality affects long-run share more than marketing.
  • Portfolio bundling (e.g., offering multiple contrast formats or concentrations) increases switching costs.

Competitive outcomes to model

  • Share stability: feasible if a supplier locks multi-year agreements or is a default tender awardee.
  • Price erosion: typical where tenders are won by the lowest bid and product interchangeability is accepted.
  • Regional fragmentation: realized pricing often differs sharply across countries and hospital systems.

How should an investor frame the investment scenario?

Scenario A: Contract-anchored supplier with stable supply

Thesis

  • The supplier is entrenched in hospital tender awards and maintains availability without allocation.
  • It holds enough volume to spread fixed costs and maintain manufacturing utilization.

Expected fundamentals

  • Revenue: steady to modest growth with imaging utilization and incremental tender share.
  • Margin: stable but exposed to periodic tender resets.

Best-fit investor view

  • Invest for cash-flow durability rather than speculative unit-price upside.

Scenario B: Generic follower with high tender exposure

Thesis

  • The supplier wins intermittent tenders, but competitive bidding compresses realized pricing.

Expected fundamentals

  • Revenue: volatile by procurement cycles.
  • Margin: lower and more variable due to contract renegotiations and substitution pressure.

Best-fit investor view

  • Model returns based on operational execution (cost position, fill-rate, regulatory throughput), not product differentiation.

Scenario C: Supply-constrained bottleneck winner

Thesis

  • A limited-capacity or regulatory bottleneck gives a supplier leverage to win tenders during shortages.

Expected fundamentals

  • Revenue: can jump during short supply periods.
  • Margin: can improve transiently but normalizes as capacity and supply rebalance.

Best-fit investor view

  • Treat upside as cyclical and demand disciplined working-capital planning.

What investment KPIs should be used to underwrite iopamidol-370?

Commercial KPIs

  • Hospital tender win rate (by geography and customer segment)
  • Contract duration and renewal yield
  • Realized price vs benchmark (net of rebates, logistics, and tender concessions)

Operational KPIs

  • Fill rate / on-time delivery
  • Batch release throughput (regulatory and QA timelines)
  • Manufacturing yield and rejection rates

Quality and compliance KPIs

  • Recall frequency and severity
  • Pharmacovigilance metrics (signal detection workload, case processing times)
  • Deviation trends tied to manufacturing steps and supplier components

Where could upside come from if exclusivity is weak?

For iopamidol-370, upside generally does not come from blockbuster-type clinical innovation. It comes from execution and distribution economics:

  • Multi-product platform leverage: packaging, concentration variety, and route coverage can reduce customer switching friction.
  • Procurement strategy: winning tenders early in the cycle and securing long-duration contracts improves price stability.
  • Cost-down programs: API sourcing improvements, process yield enhancements, and reduced unit manufacturing cost can protect gross margin even as ASPs decline.

What are the principal downside risks?

  • Price compression from competitive tendering and generic substitution.
  • Supply disruptions from manufacturing capacity constraints, regulatory lot delays, or API availability.
  • Working capital strain from contrast media procurement and distribution cycles.
  • Quality events (deviations, recall risk) that interrupt contract fulfillment and trigger customer loss.

Key Takeaways

  • Iopamidol-370 is a mature, high-volume iodinated contrast medium where procurement and supply reliability drive outcomes more than innovation.
  • Investment returns depend on tender positioning, contract durability, and manufacturing cost and availability in a market that structurally trends toward generic and authorized competition.
  • Underwrite the business with KPIs tied to realized pricing, tender win rate, delivery performance, batch release throughput, and quality event history.
  • Build scenarios around three realities: stable imaging-driven volumes, periodic tender price resets, and cyclical supply leverage that can boost margins temporarily.

FAQs

1) Is iopamidol-370 a specialty pharmaceutical investment?

No. It behaves like a procurement-driven diagnostic product. Performance is primarily driven by tender awards and supply reliability rather than breakthrough differentiation.

2) What is the “370” in iopamidol-370?

It denotes iodine concentration: 370 mg of iodine per mL in the injected contrast product.

3) Does patent exclusivity materially support long-term pricing?

For legacy iopamidol contrast products, pricing power typically weakens as authorized suppliers and generics expand. Long-term advantage usually comes from contracts and execution rather than ongoing exclusivity.

4) What matters most for due diligence?

Realized net pricing, tender win rate, on-time delivery, regulatory batch release performance, manufacturing yield, and quality event history.

5) How should investors model revenue and margin?

Model revenue as imaging-utilization driven but tender-cycle sensitive. Model margin as manufacturing-cost and contract-term dependent, with periodic compression tied to procurement resets.


References

[1] U.S. Food and Drug Administration. Drug Labels: Iopamidol Injection (various NDA holders and label histories). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] European Medicines Agency (EMA). Product information and assessment documents for iodinated contrast media and iopamidol-containing products (various authorizations). https://www.ema.europa.eu
[3] Radiological Society and contrast media guidance (non-ionic, low-osmolar iodinated contrast use in imaging; general safety and administration principles). https://www.rsna.org

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