Last Updated: August 9, 2026

OPTIRAY 240 Drug Patent Profile


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Which patents cover Optiray 240, and what generic alternatives are available?

Optiray 240 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 240 is ioversol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ioversol profile page.

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Recent Clinical Trials for OPTIRAY 240

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

SponsorPhase
GE HealthcarePhase 4
BayerPhase 4
Guerbet/Liebel-FlarsheimPhase 4

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Pharmacology for OPTIRAY 240

US Patents and Regulatory Information for OPTIRAY 240

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 019710-002 Dec 30, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 020923-001 May 28, 1998 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

International Patents for OPTIRAY 240

See the table below for patents covering OPTIRAY 240 around the world.

Country Patent Number Title Estimated Expiration
Australia 552188 ⤷  Start Trial
Australia 9151182 ⤷  Start Trial
Canada 1198739 DERIVES DE 2,4,6-TRIIODOISOPHTALAMIDE (2,4,6-TRIIODOISOPHTHALAMIDE DERIVATIVE) ⤷  Start Trial
Germany 3362967 ⤷  Start Trial
European Patent Office 0083964 COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPTIRAY 240

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0083964 SPC/GB93/089 United Kingdom ⤷  Start Trial SPC/GB93/089: 20041015
0083964 93C0142 Belgium ⤷  Start Trial PRODUCT NAME: IOVERSOL; NAT. REGISTRATION NO/DATE: 74 IS 56 F12/19910521; FIRST REGISTRATION: NL RVG 13345 19891016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: July 24, 2026

OPTIRAY 240 Market Dynamics and Financial Trajectory: Pricing, Demand Drivers, Patent/Exclusivity Overhang, and Competitive Pressure

OPTIRAY 240 (iopamidol 61% w/v injectable; 240 mg iodine/mL) is a low-to-mid value iodinated contrast media (ICM) product where pricing pressure and channel contracting drive profitability more than brand-like differentiation. Commercial performance tracks radiology volume, scan mix (CT vs other modalities), hospital conversion cycles, and payer/radiology benefit-management contracting. Financial trajectory is primarily shaped by: (1) generic entry dynamics in iodinated contrast, (2) contracting intensity in hospital purchasing, and (3) supply-chain and utilization shifts within CT imaging.

What follows is the market and financial framework for OPTIRAY 240 and the decision points that affect revenue, gross margin, and defensibility.


What market dynamics shape OPTIRAY 240 demand in CT and radiology?

ICM demand is a function of imaging utilization and product availability. OPTIRAY 240 competes inside a crowded class of iodinated contrast agents used for CT and angiographic imaging. The class dynamics are dominated by substitution and procurement levers because clinicians generally choose based on safety profile, workflow fit (contrast delivery protocols), and procurement terms rather than unique clinical brand properties.

Key demand drivers for iodinated contrast media

  • CT volume and procedure mix: As CT volume grows, ICM demand scales. Mix shifts from head and body CT to broader oncology and emergency use drive higher ICM consumption per patient episode.
  • Protocol standardization: Hospitals implement standardized contrast protocols. Once a protocol is locked, switching costs rise due to workflow validation, staff training, and procurement change control.
  • Safety and tolerability requirements: Product selection is influenced by perceived tolerability and incident management. Contracting can still dominate once safety is “good enough” across alternatives.
  • Supply continuity: Stockouts can temporarily shift utilization to alternative SKUs, then reverse when supply returns.

Key supply and channel realities

  • Hospital and IDN purchasing: Large health systems exert formulary and price discipline. Pharmacy and therapeutics committees may standardize agents for consistency.
  • Group purchasing organizations (GPOs): GPO contract pricing can compress margins quickly when multiple suppliers bid.
  • Cold-chain and manufacturing constraints: ICM is formulation- and container-dependent; small supply disruptions can change short-term mix.

Clinical positioning that matters commercially

OPTIRAY 240 is an iodinated contrast at a defined concentration and delivery format. That concentration specification matters for dosing and scan protocols, but it does not protect against substitution across equivalent concentration products when contracting and availability align.


How is OPTIRAY 240 priced and what drives net revenue per unit?

Pricing in ICM is negotiated downstream, not set upstream. For OPTIRAY 240, net revenue per unit depends on:

  1. Wholesale acquisition price (WAC) vs. discounting to wholesalers and accounts.
  2. Rebates and chargebacks linked to channel mix and contracting.
  3. GPO and health-system agreements that override list pricing.
  4. SKU-level mix (e.g., vial size and package form) that shifts average unit revenue.

Net revenue sensitivity points

  • Contracted share: If OPTIRAY 240 loses share in a high-volume IDN contract, volume can fall faster than the remaining channel can offset.
  • Competitor underbidding: When multiple suppliers chase the same hospital contract, the winner may set lower net pricing across the account.
  • Substitution at the pharmacy counter: If a therapeutics committee allows interchange within concentration and formulation category, the lowest net-cost option often wins.

Gross margin compression mechanics

ICM brand economics are structurally weak once generics or authorized equivalents enter. Margin pressure comes from:

  • increased discount rate to win/retain contracts,
  • packaging and logistics costs under competitive bids,
  • higher marketing spend that is mostly transactional (bid support) rather than brand building.

When does OPTIRAY 240 face exclusivity loss, and how does that affect revenue risk?

The financial trajectory for OPTIRAY 240 is tied to the timing of any exclusivity windows (for example, product-specific regulatory exclusivity) and to the expiration or vulnerability of any patents listed in FDA Orange Book for the marketed NDA/ANDA references.

No complete dataset is provided here to map OPTIRAY 240’s exact Orange Book listing status, patent expiration dates, or exclusivity end dates. Without verified Orange Book listings and a corresponding patent timeline, a precise “when exclusivity ends” view cannot be produced.


What patent and Paragraph IV risks exist for iodinated contrast products like OPTIRAY 240?

Market investors typically underwrite ICM with two distinct IP risk models:

  • Generic substitution model: if an equivalent ICM product can enter without meaningful formulation or method-of-use differentiation, commercialization shifts rapidly into lowest-net-cost dynamics.
  • Patent estate model: if Orange Book patents cover container closure, composition, specific concentration, or manufacturing method, generic entry may face delay or settlement terms.

No complete, source-backed OPTIRAY 240 patent estate is included in the prompt content, so a quantified Paragraph IV and settlement scenario cannot be stated.


What is the FDA regulatory and Orange Book status of OPTIRAY 240?

OPTIRAY 240 is an FDA-regulated injectable iodinated contrast product. For commercial and litigation risk analysis, the controlling artifact is the FDA Orange Book listing for the specific drug product (NDA number, active ingredient salt/form, dosage form, and strength).

A complete Orange Book status table for OPTIRAY 240 cannot be produced from the information provided.


Which companies compete with OPTIRAY 240, and how do competitor strategies affect its financial trajectory?

Competition in ICM is intense, with multiple manufacturers offering iodinated contrast agents at comparable concentrations and dosing protocols. Competitor strategies that typically drive market share and revenue outcomes:

  • Contract pricing discipline: competitors win large accounts via aggressive net pricing.
  • Portfolio breadth: providers offer multi-concentration and multi-container systems to fit protocols.
  • Supply assurances: stable manufacturing reduces lost days of supply, which protects utilization.

Competitive outcomes that determine OPTIRAY 240’s trajectory

  • If OPTIRAY 240 retains contracted accounts, revenue can remain stable even if price declines.
  • If it loses formulary position, revenue can fall quickly because switching is easy at the institutional level once contracting allows it.
  • If competitor entry triggers broader price competition across the class, gross margin can compress even if units hold.

How does OPTIRAY 240 compare with other iodinated contrast concentrations (e.g., 300 mg I/mL) in value and share risk?

Concentration affects dosing volumes and protocol economics, but commercial substitution commonly stays within the iodinated contrast category when clinical equivalence is assumed and procurement allows interchange.

Financially:

  • Products that better align with standardized protocols can hold volume even with price pressure.
  • Concentration-specific switching can be protocol-driven, so revenue risk varies by how entrenched OPTIRAY 240 is in hospital CT order sets.

No concentration-by-concentration OPTIRAY 240 share or pricing data is provided here, so a quantified comparison is not included.


What settlement and litigation dynamics typically matter for OPTIRAY 240-like ICM products?

For ICM products, litigation and settlements influence timing rather than proving clinical differentiation. Common patterns:

  • settlements that delay entry by limited time windows,
  • licensing for specific product configurations,
  • non-monetary arrangements tied to supply and market access.

Specific litigation affecting OPTIRAY 240 cannot be listed without verified case dockets and settlement documents.


What generic entry scenarios could change OPTIRAY 240 unit volume and gross margin?

For iodinated contrast products, “generic entry” is usually a step-function event for contracting:

  • a generic or authorized equivalent becomes eligible,
  • hospitals update procurement choices,
  • utilization shifts toward the lowest net option under standardized protocols.

Revenue and margin outcomes in entry scenarios

  • Moderate entry: share declines gradually if contracts grandfather existing product use.
  • Aggressive entry: abrupt share loss if a competitive bidder sweeps formulary tenders.
  • Margin floor scenario: net pricing approaches competitor levels, and profitability depends on volume offset and cost discipline.

No verified OPTIRAY 240 entry timeline or competitor launch assumptions are supplied here, so a scenario table is not produced.


What manufacturing and supply-chain/IP barriers protect OPTIRAY 240?

In ICM, barriers are typically non-patent as much as IP:

  • facility capability for aseptic or sterile manufacturing at scale,
  • validated container and fill-finish processes,
  • stability and shelf-life management.

If manufacturing capacity is constrained for a competitor, OPTIRAY 240 can hold market share temporarily even when pricing becomes less favorable.

No product-specific manufacturing capacity or IP barriers are provided for OPTIRAY 240, so they cannot be itemized.


Financial trajectory checklist: what to underwrite for OPTIRAY 240 revenue and profitability

Use this underwriting lens for budgeting, licensing strategy, or investment modeling:

  • Contract share in top IDNs: volume-weighted retention rate.
  • Net price trend vs. list WAC: rebate and chargeback pressure intensity.
  • Supply continuity metrics: days on allocation, backorder rates, and lost dispensing days.
  • Portfolio mix: vial size and packaging distribution by contracted accounts.
  • Class pricing environment: evidence of net price convergence across competitors.
  • IP/Orange Book overhang: remaining term on product-specific patents and regulatory exclusivity (must be confirmed from Orange Book).

This framework determines whether OPTIRAY 240’s financial trajectory is:

  • volume-driven growth with stable pricing,
  • price-driven erosion with stable units,
  • or shared loss tied to competitive contract replacement.

Key Takeaways

  • OPTIRAY 240 operates in a procurement-dominated iodinated contrast market where net pricing and contract share drive financial outcomes more than clinical differentiation.
  • Demand follows CT utilization, scan mix, protocol standardization, and supply continuity.
  • Revenue risk concentrates around generic or authorized-equivalent substitution via hospital contracting; gross margin compression is structurally common after increased competitive offerings.
  • A precise exclusivity and patent-timeline view for OPTIRAY 240 requires Orange Book and patent estate confirmation, which is not included in the provided input.

FAQs

1) What typically happens to iodinated contrast net pricing after authorized generic or generic competition enters?
Net prices usually compress rapidly at the contracted account level, with profitability depending on cost-to-serve and whether volume offsets margin loss.

2) How do hospital formulary decisions influence OPTIRAY 240 utilization in practice?
Formulary and protocol standardization can make switching slower, but once contracting permits interchange, utilization tends to shift toward the lowest net-cost option.

3) What role does CT procedure mix play in contrast media sales?
Higher-volume CT settings and oncology/emergency scan patterns increase ICM consumption per patient episode.

4) Do iodinated contrast products compete primarily on clinical outcomes?
Clinical tolerability matters, but commercial selection is usually driven by procurement terms, supply reliability, and protocol fit.

5) What are the earliest indicators that OPTIRAY 240’s revenue is at risk from competitive entry?
Downtrending contract share in high-volume IDNs, worsening net price capture, and increased substitution in pharmacy interchange programs.


References

No sources were provided in the prompt content, and no Orange Book, FDA, litigation, or financial filings were supplied for OPTIRAY 240; therefore no citations can be generated.

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