ISOPAQUE 280 Drug Patent Profile

Which patents cover Isopaque 280, and what generic alternatives are available?

Isopaque 280 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in ISOPAQUE 280 is calcium; meglumine; metrizoic acid. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium; meglumine; metrizoic acid profile page.

Summary for ISOPAQUE 280

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	ISOPAQUE 280 at DailyMed

US Patents and Regulatory Information for ISOPAQUE 280

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	ISOPAQUE 280	calcium; meglumine; metrizoic acid	INJECTABLE;INJECTION	017506-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ISOPAQUE 280

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	ISOPAQUE 280	calcium; meglumine; metrizoic acid	INJECTABLE;INJECTION	017506-001	Approved Prior to Jan 1, 1982

International Patents for ISOPAQUE 280

See the table below for patents covering ISOPAQUE 280 around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	6024559
Switzerland	398887	Agent de contraste pour rayons X
Germany	1192369	Roentgenkontrastmittel
Germany	1518051
Denmark	125282

Supplementary Protection Certificates for ISOPAQUE 280

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	13/2008	Austria		PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721

Last updated: June 20, 2026

ISOPAQUE 280 (iopamidol 280 mgI/mL): Market dynamics and financial trajectory

ISOPAQUE 280 is a low-osmolar iodinated contrast media (ICM) brand built on iopamidol, used across diagnostic imaging. Its market is driven by procedure volumes (CT, angiography), hospital formulary dynamics, pricing pressure from generics and authorized equivalents, and periodic supply or reimbursement shocks. Financial trajectory depends on (1) how aggressively payers and hospital systems switch from brand to lower-cost equivalents, (2) the share captured by iopamidol molecule competitors in the same dose-and-iodine strength segment, and (3) contract pricing and tender wins that can shift utilization quickly.

How does the market for ISOPAQUE 280 perform versus iopamidol rivals?

Core demand driver: iodinated contrast administration volumes track directly with imaging throughput. ISOPAQUE 280 competes in the iopamidol class and within the broader ICM market, where hospitals often standardize by molecule (e.g., iopamidol) and by concentration (e.g., 240, 250, 280 mgI/mL).

Competition structure:

• Direct brand-to-brand: other iopamidol 280 products and equivalents offered by multiple manufacturers.
• Molecule substitution: some systems shift within ICMs (different nonionic agents such as iohexol, ioversol, iobitridol) based on procurement terms, perceived safety/tolerability, and supply reliability.
• Authorized generics/equivalents: when present, these compress net pricing faster than branded products.

Featured snippet answer: ISOPAQUE 280’s performance is most sensitive to hospital contract pricing and formulary consolidation within the iodinated contrast category, not to incremental clinical adoption.

What hospital procurement levers move ISOPAQUE 280 volume?

• GPO and IDN group tenders: bulk awards frequently rebase unit economics mid-cycle.
• Contrast utilization protocols: order sets and prefilled syringe workflows increase stickiness, reducing switching unless pricing gaps widen.
• Renal safety pathways and adverse event review: a switch from one agent to another can slow after protocol lock-in, but resumes when net cost or supply issues change.

Does concentration (280 mgI/mL) change the competitive dynamics?

Yes. Hospitals segment by:

• CT angiography protocols that prefer specific viscosity/osmolality profiles and injection equipment compatibility.
• Adult dosing patterns that target consistent iodine delivery at preferred volumes.
  Concentration-specific tender awards can cause disproportionate share shifts even if molecule-level preference remains stable.

What are the key pricing and reimbursement pressures impacting ISOPAQUE 280 net sales?

Pricing reality in contrast media: ICMs experience ongoing price compression due to:

• Competition from authorized equivalents and other nonionic ICMs.
• Tender-based contracting that ties reimbursement and acquisition costs into negotiated discounts.
• Channel mix effects: institutional purchasing typically yields different discount structures than retail.

Revenue sensitivity: In ICM, small percentage changes in net price can outweigh modest volume changes because unit costs are tightly managed.

What contract patterns typically affect quarterly revenue trajectory?

• Mid-year rebates and chargebacks that can lag shipment schedules.
• Switching cycle timing: once a hospital switches, it can be immediate for new orders but slower for accumulated inventory, producing lumpy consumption patterns.
• GPO re-assignments at contract renewal windows.

How do procedure volumes translate into ISOPAQUE 280 financial trajectory?

Transmission mechanism:

1. Imaging demand rises or falls (CT throughput, angiography volumes).
2. ICM utilization per procedure remains relatively stable once protocols mature.
3. ISOPAQUE 280’s share depends on formulary position and procurement outcomes.

What macro factors influence imaging volumes?

• Healthcare utilization trend (post-acute care normalization, elective procedures).
• Payer utilization management affecting imaging frequency.
• Seasonality (some centers show predictable variation in ED admissions and imaging intensity).

What operational factors can swing short-term outcomes?

• Supply interruptions across ICM manufacturing can force substitution, creating temporary share loss.
• Regulatory or quality events can trigger recall-related stock behavior.

Where does ISOPAQUE 280 sit in the broader ICM market growth curve?

Iodinated contrast media is a mature category. Growth typically reflects:

• Volume growth from expanding imaging utilization and aging demographics.
• Share shifts driven by tender pricing.
• Limited product differentiation relative to clinical outcomes unless supported by specific workflow or tolerability narratives.

Featured snippet answer: Category growth is volume-led; brand growth is share-led, with price pressure acting as the dominant drag.

Do newer imaging modalities reduce long-term ICM demand?

Not materially in the near-to-medium term because:

• CT remains a workhorse for many indications.
• Alternative modalities (MRI, ultrasound) do not fully replace iodinated contrast for many angiography and CT indications.

What generic or authorized-equivalent entry risks exist for ISOPAQUE 280?

The competitive threat to ISOPAQUE 280 is less about de novo competition and more about:

• Evergreening coverage gaps that can allow equivalents to launch when practical.
• Regulatory pathway enablement for generic-equivalent versions of iopamidol-containing ICM.

Featured snippet answer: The largest financial risk is continued erosion of net price due to generic or authorized-equivalent penetration within the same concentration and package formats.

Where do entry dynamics usually show up financially?

• Net sales decline after tender switches rather than at a single launch date.
• Gross-to-net margin pressure as the company adjusts pricing, rebates, and contracting terms to defend accounts.

What does the expected financial trajectory look like under different procurement scenarios?

Scenario A: Stable formulary position

• Volume remains steady.
• Net price declines modestly through incremental contract concessions.
• Financial performance tracks category volume.

Scenario B: Partial tender loss within iopamidol 280

• Volume shifts to competing equivalents.
• Brand may retain a higher-margin slice in certain integrated delivery networks.
• Revenue shows step-down dynamics during renewal windows.

Scenario C: Broad tender loss and aggressive price matching

• Material volume erosion.
• Net price compression accelerates due to account renegotiations.
• Operating leverage turns negative if fixed costs are not offset by cost reduction.

How does channel mix (hospital vs alternate sites) affect ISOPAQUE 280 revenue profile?

ISOPAQUE 280 is predominantly institutionally used. Financial trajectory varies with:

• Inpatient vs outpatient imaging mix: outpatient growth can add volume but may negotiate lower acquisition costs.
• Retail pharmacy inventory exposure: typically lower than institutional channels for ICMs, but any expansion can change discount structures.

What packaging and administration format dynamics influence sales?

ICM demand is tied to injection workflows:

• Single-use formats and prefilled options can reduce preparation time and improve adoption.
• Syringe compatibility and infusion equipment handling matter at procurement time.
• Switching can be constrained by device-to-product integration.

What Key metrics should investors and operators track for ISOPAQUE 280?

For market and financial monitoring, focus on:

• Unit shipments and utilization in iopamidol 280 strength.
• Net price per unit after rebates, chargebacks, and contract discounts.
• Account retention rate across top IDNs and GPO-aligned systems.
• Concentration mix (280 mgI/mL share relative to other strengths).
• Inventory behavior around contract renewal, supply constraints, and formulary changes.

Key Takeaways

• ISOPAQUE 280 demand is procedure-volume driven, with hospital procurement and formulary placement determining share.
• Net sales trajectory is more sensitive to net price and contract timing than to marginal clinical differentiation.
• The main downside risk is continued pricing pressure from authorized equivalents and iopamidol concentration-specific tender losses, producing step-changes in volume around renewal cycles.
• Near-term performance should be modeled as category-volume plus share-price interaction, with gross-to-net margin compression as the primary watch item.

FAQs

1) How does CT volume growth affect iodinated contrast sales for iopamidol 280 brands like ISOPAQUE 280?
CT throughput is the primary demand driver; as CT procedures rise, ICM utilization scales with stable dosing protocols, so sales track imaging volumes and per-procedure iodine delivery.

2) What typically causes sudden quarter-to-quarter ISOPAQUE 280 revenue swings?
Tender-driven formulary changes, inventory stocking ahead of contract renewals, and supply disruptions that force substitution.

3) Does ISOPAQUE 280 compete more on molecule choice or on iodine concentration (280 mgI/mL)?
Both, but concentration-specific tender wins can be decisive because protocols and injection workflows favor specific strengths and viscosity characteristics.

4) What procurement metrics best predict share erosion for iopamidol 280?
Net acquisition price gaps versus authorized equivalents, contract award timing, and retention across large GPO/IDN accounts.

5) How does gross-to-net margin pressure usually show up for contrast media brands?
Through rebates, chargebacks, and price concessions that reduce net revenue per unit even if shipments hold steady.

---

References

1. No citations provided.