ISOPAQUE 440 Drug Patent Profile

When do Isopaque 440 patents expire, and what generic alternatives are available?

Isopaque 440 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in ISOPAQUE 440 is calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium. There is one drug master file entry for this compound. Additional details are available on the calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium profile page.

Summary for ISOPAQUE 440

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	2,134
DailyMed Link:	ISOPAQUE 440 at DailyMed

US Patents and Regulatory Information for ISOPAQUE 440

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 440	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium	INJECTABLE;INJECTION	016847-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ISOPAQUE 440

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	ISOPAQUE 440	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium	INJECTABLE;INJECTION	016847-001	Approved Prior to Jan 1, 1982

International Patents for ISOPAQUE 440

See the table below for patents covering ISOPAQUE 440 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
Spain	271951

Supplementary Protection Certificates for ISOPAQUE 440

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
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
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	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321

Last updated: July 25, 2026

ISOPAQUE 440 market dynamics and financial trajectory (2026 snapshot)

ISOPAQUE 440 (iopamidol 44% w/v), a non-ionic, iodinated contrast medium used in computed tomography (CT) and angiography, operates in a procurement-and-contract market with pricing tied to hospital formularies, group purchasing organization (GPO) contracts, and acute-care utilization volumes. The financial trajectory is driven by (1) recurring imaging demand, (2) channel mix (hospital buy vs. distributor), (3) competitive substitution within iopamidol and alternative iodinated agents, and (4) margin pressure from commodity iodine-linked inputs and contract renegotiations.

Public, audited financials by product line for “ISOPAQUE 440” are not typically disclosed by manufacturers because contrast brands are often reported within broader “pharmaceutical” or “injectables” segments. As a result, product-level revenue forecasting must be inferred from category economics, utilization trends, and known competitive and regulatory structures (generic and authorized equivalents for iopamidol).

What is ISOPAQUE 440 and where does it sell in the contrast media market?

ISOPAQUE 440 is an iodinated contrast drug product with iopamidol as the active ingredient, supplied for radiographic imaging applications. The market structure for iodinated contrast is dominated by hospital systems, imaging centers, and radiology group procurement, with high switching friction due to clinical familiarity, prescriber habits, and formulary status.

Which therapeutic/indication segments buy ISOPAQUE 440?

• CT imaging across emergency, inpatient, and outpatient imaging settings
• Angiography and vascular imaging
• Interventional radiology workflows where contrast supply reliability matters

What commercial channels typically control purchasing?

• GPO contracting and direct hospital pharmacy procurement
• Distributor sales to community hospitals and imaging centers
• Conversion between brands and strengths based on contract scope and conversion programs

How do pricing and contracting dynamics shape ISOPAQUE 440 revenue?

Contrast media is priced through list-price-to-net-price mechanics. Net pricing is primarily determined by:

• Contract type (national, regional, or facility-level)
• Multi-product bundles within iodinated contrast portfolios
• Price protection and rebate schedules
• Conversion programs (brand-to-brand or brand-to-generic within the same molecule)

Key market levers

1. Formulary retention: If ISOPAQUE 440 is the entrenched “default” option, revenue is sticky even amid competitive pressure.
2. Contract renewals: Financial trajectory often shows step-downs around renewal periods when competitors underbid.
3. Conversion and substitution: Many hospitals run internal substitution policies for equivalent contrast agents; authorized generics and molecule-level competition reduce pricing power.

What drives net price compression in iodinated contrast?

• Increased authorized generic presence across strengths
• Competitive tenders that reset unit pricing
• Distributor and GPO margin demands during supply-tight periods

What competitive risks most affect ISOPAQUE 440 market share?

ISOPAQUE 440’s competitive set is best understood as “iodinated contrast at 44% iopamidol strength,” plus broader switching across non-ionic iodinated agents when procurement favors volume-based pricing.

Molecule and strength substitution risk

• Iopamidol alternatives at different strengths may be substituted if protocols allow
• Other non-ionic iodinated contrasts may replace iopamidol under contracting pressure

Authorized generic and private label pressure

• Where authorized equivalents exist, purchasing teams often treat them as interchangeable at the invoice level, especially in CT workflow.

Supply reliability as a competitive advantage

Contrast markets can swing on allocation and backorders. Any supply interruption can shift utilization to alternative brands until the backlog clears, creating revenue loss that can persist after resupply.

How does regulatory and manufacturing status influence ISOPAQUE 440 commercialization?

For contrast media, regulatory status and manufacturing compliance affect availability and contract retention more than long-horizon exclusivity. Even absent a “patent wall” dynamic, product availability controls market share.

FDA labeling and change control

• Labeling breadth and protocol alignment reduce switching friction
• Manufacturing changes require regulatory reporting and can create transient supply risk

Market access via FDA approvals

• Any new entrant’s ability to be stocked and dispensed depends on pharmacy committee acceptance and procurement readiness, not just FDA approval.

When does ISOPAQUE 440 lose exclusivity, and how does that impact finances?

Contrast media products often face earlier generic erosion at the molecule or strength level than newer specialty drugs, which changes financial trajectory from “premium pricing” to “contract pricing.”

However, a precise “loss of exclusivity” timeline for ISOPAQUE 440 requires mapping the specific product’s FDA approvals, listed patents, and Orange Book exclusivity windows. Without that itemized patent-and-exclusivity dataset for ISOPAQUE 440, a definitive expiration-based forecast cannot be stated here.

What is the Orange Book status of ISOPAQUE 440, and why does it matter to the P&L?

Orange Book status is a proxy for:

• Expected timing of generic/authorized generic entry
• Strength and count of listed patents that can delay entry
• Likelihood of Paragraph IV litigation dynamics

For ISOPAQUE 440, product-specific Orange Book detail (listed patents, expiration dates, exclusivity codes) is needed to translate status into financial risk bands. Without that dataset, the only actionable conclusion is that iodine-based injectables typically see significant price competition once authorized or generic equivalents are available and stocked.

How do generic entry scenarios affect ISOPAQUE 440 revenue?

Generic erosion in contrast media generally plays out through:

• Unit price declines: net price drops after competitive contract re-tendering
• Share shifts: clinicians may remain loyal, but procurement can force conversion
• Portfolio rationalization: hospitals consolidate to fewer SKUs to reduce administrative burden

Financial signature of generic pressure

• Gradual volume retention followed by sharper net sales decline at renewal cycles
• Margin compression from lower invoice pricing plus contract rebates

How does ISOPAQUE 440 compare with other iodinated contrast agents commercially?

The commercial comparison across iodinated contrasts often comes down to:

• Net price and contract terms
• Inventory stability and lead times
• Administration characteristics that influence workflow efficiency
• Institutional experiences with adverse event profiles, which drive internal policy

Where ISOPAQUE 440 tends to perform well

• Institutions with established iopamidol protocols and stocked supply
• Regions where iopamidol contracts offer favorable net pricing

Where it is most exposed

• Facilities that run aggressive tendering and SKU consolidation
• Contracts that include multiple competing iopamidol or multi-molecule alternatives

What are the market demand trends affecting ISOPAQUE 440?

Demand is linked to imaging utilization:

• CT procedure volumes correlate with diagnostic capacity, outpatient imaging growth, and ED utilization
• Short-term swings occur with healthcare utilization cycles and public health events

Volume stability vs. pricing pressure

Even when procedure volumes grow, the net revenue can lag due to contract-based price decreases. Over time, the category’s economics often shift from brand premium to negotiated pricing.

What financial trajectory should be expected for ISOPAQUE 440 over 12 to 36 months?

Without product-line financial disclosures, the most defensible trajectory is a direction-of-travel forecast based on category mechanics:

• Revenue: likely follows imaging volume with downside risk from further net price compression
• Gross margin: pressured by contract pricing, freight and distribution economics, and input-cost fluctuations
• Operating margin: affected by scale, rebates, and promotional spend tied to formulary conversion

A typical trajectory in mature contrast markets is:

• Stable to modest revenue growth if imaging utilization rises faster than net price declines
• Revenue stagnation to decline if contract renegotiations reset net price or if share shifts to lower-cost equivalents

Which data points determine ISOPAQUE 440’s next financial inflection?

For business planning, the inflection indicators are:

• Hospital/GPO contract renewal outcomes for iopamidol 44%
• Distributor allocation status and order fill rates
• SKU consolidation trends within contrast product portfolios
• Competitive tender cycles and authorized equivalent stocking decisions

Key Takeaways

• ISOPAQUE 440 is a mature iodinated contrast product whose financial trajectory is primarily governed by hospital contracting, net price compression, and supply reliability rather than long-cycle specialty exclusivity dynamics.
• Expect revenue to track CT and interventional imaging procedure volumes, with margin and net sales influenced by contract renegotiations and substitution to authorized equivalents or alternative iodinated agents.
• The biggest commercial swing factors are GPO and hospital tender cycles, authorized generic competition, and inventory/fulfillment performance during supply constraints.

FAQs

1. How does GPO contracting typically impact net pricing for iodinated contrast brands like ISOPAQUE 440?
2. What factors drive hospital formulary switching between iopamidol and alternative non-ionic iodinated contrast media?
3. How do supply interruptions in iodinated contrast media usually affect share after resupply?
4. What is the common financial pattern of mature injectable contrast products during periods of authorized generic expansion?
5. How can a buyer model cost-per-scan changes when net prices shift across different iodinated contrast strengths?

References

1. Bloomberg / market practice references for US hospital contracting and net-to-list pricing dynamics (general).
2. FDA Orange Book (general principle reference for exclusivity and patent listings).
3. FDA labeling framework for iodinated contrast media (general).