IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM - Generic Drug Details

What are the generic sources for ioxaglate meglumine; ioxaglate sodium and what is the scope of freedom to operate?

Ioxaglate meglumine; ioxaglate sodium is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM at DailyMed

US Patents and Regulatory Information for IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985		DISCN	No	No

Expired US Patents for IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985

Ioxaglate Meglumine and Ioxaglate Sodium Market Dynamics, Patents, and Financial Trajectory

Last updated: September 9, 2026

Ioxaglate meglumine and ioxaglate sodium are the ionic, dimeric contrast agents formerly marketed in the United States as Hexabrix. The product’s commercial position has materially deteriorated: its principal patents and regulatory exclusivities expired decades ago, the U.S. product was discontinued, and clinical demand shifted toward nonionic low-osmolar and iso-osmolar contrast media. The current value of the ioxaglate franchise is therefore limited to residual geographic sales, legacy supply arrangements, or specialized institutional use rather than a growth-oriented pharmaceutical opportunity.

What is ioxaglate meglumine and ioxaglate sodium?

Ioxaglate is a water-soluble, iodinated radiographic contrast medium supplied as a combination of ioxaglate meglumine and ioxaglate sodium. It is an ionic dimer containing two iodine atoms per aromatic ring system and is used to improve visualization during radiographic procedures.

Hexabrix formulations were supplied at iodine concentrations including 320 mg iodine/mL. The product was used in procedures such as:

• Cerebral and peripheral angiography
• Visceral angiography
• Coronary angiography and left ventriculography
• Digital subtraction angiography
• Contrast-enhanced computed tomography
• Intravenous angiographic procedures

The product’s principal pharmacologic limitation is its ionic nature. Ionic agents generally have higher osmolality than nonionic low-osmolar or iso-osmolar products, increasing the clinical and commercial preference for newer agents in many procedures. U.S. prescribing information identifies risks associated with intravascular iodinated contrast, including hypersensitivity reactions, renal injury, cardiovascular effects, and extravasation-related injury. (U.S. Food and Drug Administration [FDA], n.d.-a)

What is the difference between ioxaglate meglumine and ioxaglate sodium?

The two salts are co-formulated rather than commercialized as separate finished pharmaceutical products. Meglumine and sodium provide the counterions needed to produce the water-soluble ioxaglate formulation.

Attribute	Ioxaglate meglumine	Ioxaglate sodium
Role	Salt form in finished contrast formulation	Salt form in finished contrast formulation
Standalone U.S. product	No meaningful standalone market	No meaningful standalone market
Primary commercial association	Hexabrix	Hexabrix
Therapeutic category	Iodinated X-ray contrast medium	Iodinated X-ray contrast medium
Current commercial relevance	Legacy or regional	Legacy or regional

The relevant commercial asset is the combined ioxaglate product, not separate branded markets for the two salts.

What is the FDA regulatory status of ioxaglate?

The U.S. Hexabrix product is listed by FDA as discontinued. FDA’s discontinued-drug status does not by itself mean that the product was withdrawn for safety or effectiveness reasons. It indicates that the listed product is no longer marketed under the relevant application. FDA’s Drugs@FDA and labeling records identify Hexabrix as a prescription iodinated contrast agent with a discontinued U.S. marketing status. (FDA, n.d.-a; FDA, n.d.-b)

What is the Orange Book status of Hexabrix?

The Orange Book does not provide a durable exclusivity barrier for ioxaglate comparable to a recently approved branded drug. The relevant product has no commercially meaningful remaining New Chemical Entity exclusivity, orphan exclusivity, or unexpired foundational patent protection.

The practical Orange Book implications are:

Orange Book issue	Current commercial implication
Listed reference product	Historically associated with Hexabrix
New chemical entity exclusivity	Expired
Formulation exclusivity	Expired or commercially immaterial
Patent-based delay	No current material barrier identified
U.S. marketing status	Discontinued
Generic substitution opportunity	Limited by lack of active U.S. reference-product commercialization

A discontinued reference product can complicate a conventional abbreviated new drug application strategy. A potential entrant would need to assess whether an ANDA can rely on the discontinued product, whether a suitability petition or alternative regulatory pathway is required, and whether the product is commercially viable at current hospital purchasing prices. FDA’s publication of a discontinued status does not eliminate all regulatory pathways, but it reduces the attractiveness of a standard generic launch. (FDA, n.d.-b; FDA, n.d.-c)

When did ioxaglate lose exclusivity and patent protection?

Ioxaglate’s core exclusivity period ended many years ago. The product was developed in the era when ionic contrast agents dominated angiography, before the broad commercial adoption of low-osmolar nonionic agents.

No active, commercially significant U.S. patent estate is associated with the original ioxaglate active ingredient. Any foundational composition, formulation, or use patents would have expired long before the product’s U.S. discontinuation. Later patents, if any, would have related to packaging, manufacturing, administration systems, or narrow formulation details rather than the basic right to market ioxaglate.

What patents protect ioxaglate meglumine and ioxaglate sodium?

The practical patent position is weak:

Patent category	Current relevance
Active ingredient composition	Expired
Salt combination	Expired or no longer commercially blocking
Original clinical uses	Expired
Injection formulation	Expired or vulnerable to design-around
Container and packaging	Potentially narrow and jurisdiction-specific
Manufacturing process	Potentially confidential or process-specific, not a product monopoly
Device or injector integration	Separate from the drug and unlikely to protect the active ingredient

A definitive freedom-to-operate analysis would require a live search across U.S., European, Japanese, and other national databases, including assignments, continuations, terminal disclaimers, and national-phase filings. The commercial conclusion is nevertheless clear: ioxaglate is an off-patent product with no evident patent-based pricing power.

Are there Paragraph IV challenges or generic launch risks?

There is no major current U.S. Paragraph IV dispute shaping the ioxaglate market. The product’s commercial decline predates the current wave of generic contrast-media litigation, and the absence of an active branded U.S. market reduces the incentive for a conventional Paragraph IV launch.

Generic-entry risks are more operational than legal:

1. A generic manufacturer may face limited demand because hospitals have standardized on nonionic products.
2. FDA comparability requirements for contrast media include quality, impurity, osmolality, viscosity, iodine concentration, sterility, and container compatibility.
3. Hospitals may require supplier qualification and switching protocols even where the product is technically substitutable.
4. Low production volumes can make batch economics unattractive.
5. Procurement contracts often favor broader contrast portfolios and reliable supply rather than the lowest unit price.

The most plausible entry model would be a niche hospital or regional supply business, not a high-value branded-generic launch.

What formulations are protected by ioxaglate patents?

The commercially important formulation was the aqueous combination of ioxaglate meglumine and ioxaglate sodium. The formulation’s technical requirements include:

• Stable iodine concentration
• Controlled pH and osmolality
• Low particulate burden
• Sterility and endotoxin control
• Compatibility with glass or polymer containers
• Acceptable viscosity for angiographic injection
• Consistent performance in automated injectors

These attributes can create manufacturing and quality barriers without creating durable patent exclusivity. Formulation know-how, analytical methods, and validated sterilization processes may remain useful trade secrets, but they do not prevent competitors from developing an equivalent product.

How does ioxaglate compare with competing contrast agents?

Ioxaglate competes within a mature iodinated contrast market dominated by nonionic low-osmolar and iso-osmolar products.

Product or class	Representative ingredient	Osmolality profile	Current market position
Hexabrix	Ioxaglate meglumine/sodium	Ionic, relatively high	Legacy or discontinued in the U.S.
Omnipaque	Iohexol	Nonionic, low-osmolar	Major global hospital product
Isovue	Iopamidol	Nonionic, low-osmolar	Major U.S. competitor
Optiray	Ioversol	Nonionic, low-osmolar	Established hospital competitor
Visipaque	Iodixanol	Nonionic, iso-osmolar	Premium segment, especially renal-risk settings
Ultravist	Iopromide	Nonionic, low-osmolar	Major international competitor

The main substitution pressure is clinical and procurement-based. Nonionic agents generally offer a more favorable tolerability profile and fit current angiography, CT, and interventional-radiology protocols. Ioxaglate therefore competes against products with stronger global distribution, broader label usage, active manufacturing capacity, and established hospital contracts.

What is the financial trajectory of ioxaglate?

Public-company reporting does not generally disclose standalone revenue for ioxaglate meglumine and ioxaglate sodium. The product was historically embedded within broader contrast-media portfolios, making product-level revenue reconstruction unreliable.

The financial trajectory is best characterized as follows:

Period	Financial condition
Initial commercialization	Growth driven by expansion of angiography and radiographic imaging
Late mature period	Decline as nonionic low-osmolar agents displaced ionic products
Post-patent period	Price compression and generic or portfolio substitution
U.S. discontinuation period	Revenue effectively reduced to zero in the U.S. branded channel
Current period	Limited or unquantified regional, legacy, or institutional revenue

The product’s economic value is constrained by four factors:

• No meaningful patent premium
• Declining clinical preference for ionic contrast media
• Discontinued U.S. commercial status
• Manufacturing economics that favor higher-volume contrast agents

The larger iodinated contrast market remains substantial because CT imaging, interventional cardiology, oncology imaging, and emergency medicine continue to generate demand. That market growth does not translate directly into ioxaglate growth because volume is concentrated in newer agents.

Which companies are challenging or replacing ioxaglate?

No significant company is publicly positioned as an ioxaglate-specific challenger. Replacement is occurring through competing contrast-media portfolios.

The principal competitive groups include:

• GE HealthCare, with iohexol-based Omnipaque
• Bracco, with iopamidol and related contrast products
• Bayer, with iopromide-based Ultravist
• Guerbet, with iodixanol, ioxitalamic-acid-related products, and other imaging agents
• Liebel-Flarsheim and successor commercial organizations associated with legacy contrast products

Guerbet’s acquisition of Mallinckrodt’s contrast-media and delivery-systems business expanded Guerbet’s position in established contrast products and distribution infrastructure. The transaction strengthened portfolio scale but did not restore ioxaglate’s U.S. growth profile. (Guerbet, 2015)

What litigation and licensing issues affect ioxaglate?

There is no major active patent litigation or settlement agreement publicly associated with ioxaglate that materially affects current market entry. Historical disputes involving contrast media may concern manufacturing, labeling, supply, or broader product portfolios rather than a surviving ioxaglate composition patent.

Licensing value is also limited. A prospective commercial arrangement would more likely involve:

• Access to a validated manufacturing process
• A regional marketing authorization
• Contract manufacturing
• Legacy regulatory documentation
• Supply of an established contrast-media portfolio

An ioxaglate-only license would have weak strategic value unless tied to an existing hospital distribution network or a region with continuing demand for the product.

What generic launch scenarios exist for ioxaglate?

Three launch scenarios are commercially plausible.

U.S. relaunch

A U.S. relaunch would face the greatest uncertainty. The product is discontinued, and the market has moved toward nonionic alternatives. A new entrant would need to establish regulatory feasibility, manufacturing economics, and hospital demand before committing capital.

Regional generic supply

A regional launch in a market where ioxaglate remains authorized could be viable if the manufacturer already produces sterile contrast media and has access to hospital tenders. Margins would likely be modest.

Portfolio acquisition

The most realistic transaction would package ioxaglate with other mature contrast products, manufacturing assets, or distribution rights. An isolated acquisition of ioxaglate rights would have limited valuation support.

What manufacturing and geographic barriers remain?

The principal barriers are not patents. They are regulatory, quality, and supply-chain requirements.

A manufacturer must demonstrate control of:

• Iodinated starting materials
• Salt formation and impurity profile
• Sterile filling
• Endotoxin and particulate limits
• Container closure integrity
• Stability under storage and transport conditions
• Compatibility with angiographic injectors
• Regional pharmacopoeial requirements

Geographic opportunity is likely highest where legacy ionic contrast products remain approved and where procurement systems are price-sensitive. The United States and Western European markets are less attractive because hospitals have adopted broader portfolios of nonionic products and because the branded U.S. product is discontinued.

How strong is the patent estate for ioxaglate?

The patent estate is weak for investment and litigation purposes. Ioxaglate has no apparent remaining composition-of-matter barrier, no meaningful market exclusivity, and no active branded U.S. franchise capable of sustaining premium pricing. Any remaining rights would likely be narrow, country-specific, process-related, or associated with packaging and delivery systems.

Key Takeaways

• Ioxaglate meglumine and ioxaglate sodium were commercialized primarily as Hexabrix.
• The U.S. Hexabrix product is discontinued according to FDA records.
• Core patent and regulatory exclusivity expired decades ago.
• No major current Paragraph IV dispute or patent litigation drives the market.
• Nonionic low-osmolar and iso-osmolar products have displaced ioxaglate in most major markets.
• Standalone revenue is not publicly reported and is likely negligible in the U.S.
• Any remaining value is tied to regional approvals, contract supply, or portfolio transactions.
• Manufacturing quality, sterile filling, regulatory maintenance, and hospital contracting are more important barriers than patents.
• A generic relaunch would be a niche opportunity rather than a major pharmaceutical growth asset.

FAQs

Is Hexabrix still available in the United States?

FDA records identify Hexabrix as discontinued in the United States. The product should not be treated as an active U.S. branded growth product.

Is ioxaglate a generic contrast agent?

Ioxaglate is an off-patent contrast agent, but practical generic availability depends on country-specific approvals, reference-product status, manufacturing capacity, and hospital demand.

Does ioxaglate have biosimilar competition?

No. Ioxaglate is a chemically synthesized small-molecule contrast medium, not a biologic. Biosimilar regulation does not apply.

Why did nonionic contrast agents replace ioxaglate?

Nonionic low-osmolar and iso-osmolar agents offered improved clinical tolerability and stronger alignment with modern CT, angiography, and interventional-radiology practice.

Could ioxaglate become commercially valuable again?

A broad resurgence is unlikely. A limited regional opportunity could exist where the product remains authorized, procurement is price-sensitive, and a manufacturer can operate sterile contrast production at sufficient scale.

References

1. Guerbet. (2015). Guerbet completes acquisition of Mallinckrodt’s contrast media and delivery systems business. https://www.guerbet.com
2. U.S. Food and Drug Administration. (n.d.-a). Hexabrix: Ioxaglate meglumine and ioxaglate sodium injection prescribing information. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. Food and Drug Administration. (n.d.-b). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
4. U.S. Food and Drug Administration. (n.d.-c). Approved drug products with therapeutic equivalence evaluations. Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book