HYPAQUE Drug Patent Profile

When do Hypaque patents expire, and when can generic versions of Hypaque launch?

Hypaque is a drug marketed by Ge Healthcare and is included in five NDAs.

The generic ingredient in HYPAQUE is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hypaque

A generic version of HYPAQUE was approved as diatrizoate meglumine; diatrizoate sodium by ANDA REPOSITORY on June 27^th, 2022.

Summary for HYPAQUE

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	4
DailyMed Link:	HYPAQUE at DailyMed

Recent Clinical Trials for HYPAQUE

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

Sponsor	Phase
Institute of Liver and Biliary Sciences, India	N/A
Dartmouth-Hitchcock Medical Center	Phase 2
Spectrum Pharmaceuticals, Inc	Phase 2

See all HYPAQUE clinical trials

US Patents and Regulatory Information for HYPAQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	HYPAQUE	diatrizoate sodium	FOR SOLUTION;ORAL, RECTAL	011386-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE SODIUM 20%	diatrizoate sodium	SOLUTION;URETERAL	009561-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE	diatrizoate sodium	INJECTABLE;INJECTION	009561-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE-76	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	086505-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE	diatrizoate sodium	INJECTABLE;INJECTION	009561-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE	diatrizoate meglumine	INJECTABLE;INJECTION	016403-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE	diatrizoate sodium	SOLUTION;ORAL, RECTAL	011386-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for HYPAQUE

Last updated: March 12, 2026

What is HYPAQUE and its Approved Uses?

HYPAQUE (ioxaglate meglumine) is an iodinated contrast agent. It is approved primarily for use in X-ray and computed tomography (CT) imaging of the gastrointestinal (GI) tract, including the esophagus, stomach, and intestines. The drug enhances visualization of GI structures in diagnostic procedures.

Market Size and Key Drivers

The global gastrointestinal imaging market, which includes contrast agents like HYPAQUE, was valued at approximately USD 700 million in 2020. It is projected to grow at a compound annual growth rate (CAGR) of around 6.5% through 2028. The key drivers include aging populations, increased incidence of GI disorders, and rising adoption of minimally invasive diagnostic procedures.

Competitive Landscape and Market Share

HYPAQUE remains a niche product within the iodinated contrast agent segment. Major competitors include:

• Gastrografin (meglumine amidotrizoate and sodium amidotrizoate): Used for GI imaging and therapeutic purposes.

• Lumirem (sodium iothalamate): Primarily for radiographic examination of the GI tract.

• Barium sulfate-based contrast media: Used as alternatives in many GI imaging contexts.

HYPAQUE's market share is limited relative to barium sulfate due to preference for non-iodinated agents in specific procedures. However, its use persists in cases requiring water-soluble and less viscous agents.

Regulatory Status and Market Access

HYPAQUE was approved by the U.S. Food and Drug Administration (FDA) in the 1980s and by the European Medicines Agency (EMA) thereafter. Its global sales are concentrated in North America and Europe but face challenges from generic competition and evolving imaging protocols favoring alternative contrast agents.

Pricing and Revenue Generation

Pricing varies by region:

Region	Average Price per Dose (USD)	Notes
North America	$50 - $100	Higher due to healthcare spending levels
Europe	$40 - $80	Negotiated through payers
Asia Pacific	$20 - $50	Lower due to market maturity

Sales revenues for HYPAQUE have declined over recent years. In 2019, estimated global sales hovered around USD 50 million, with a downward trend driven by substitution effects and clinical practice shifts.

Factors Impacting Future Financial Performance

• Patent and Regulatory Exclusivity: No recent patent protections; generic versions available.

• Market Competition: Growing preference for alternative imaging agents, notably barium-based solutions and newer water-soluble agents.

• Clinical Practice Trends: Emphasis on non-invasive imaging and reduced use of iodinated contrast agents in certain procedures.

• Manufacturing and Supply Chain: Corporate strategies involve declining production in favor of newer products, affecting long-term revenue.

Recent Developments

No recent FDA or EMA approvals for HYPAQUE. Companies have shifted focus toward other contrast agents with superior safety profiles, such as iohexol and iodixanol. Regulatory authorities have issued warnings regarding iodinated contrast risks in patients with renal impairment, influencing market dynamics.

Financial Outlook

Given the stagnant or declining sales basis and the absence of new indications or formulations, HYPAQUE's revenue stream is expected to contract. Industry analysts project a 3-5% annual decline over the next five years unless a new use or formulation emerges.

Strategic Considerations

Investors and stakeholders should evaluate:

• The product’s market positioning relative to newer contrast agents.

• The potential for lifecycle extension through new indications or formulations.

• Opportunities in emerging markets with less competition and growing healthcare infrastructure.

Key Takeaways

HYPAQUE operates in a niche segment of the gastrointestinal contrast imaging market with declining revenue due to competition, evolving clinical practices, and saturation. Its future hinges on strategic choices around lifecycle management and potential new indications. The overall financial trajectory is downward unless market shifts create new demand.

FAQs

1. Why is HYPAQUE’s market share decreasing?
It is decreasing because clinicians prefer more modern contrast agents with fewer safety concerns and better imaging qualities, leading to reduced use of hyaluronic-based contrast media.

2. Are there any upcoming regulatory changes affecting HYPAQUE?
No significant regulatory developments are announced. Past restrictions focus on iodinated contrast agent safety considerations, particularly in patients with renal impairment.

3. Can HYPAQUE be used in new diagnostic applications?
Currently, it is approved solely for GI imaging. Expanding the indications would require regulatory approval and clinical validation.

4. How does pricing impact HYPAQUE’s revenue?
Pricing remains relatively stable but is influenced by regional negotiations. Price reductions in response to competition have occurred in some markets.

5. What strategies could revive HYPAQUE’s market?
Strategies include developing new formulations, obtaining additional indications, or differentiating through safety and efficacy profiles. However, evidence suggests limited opportunities given current market trends.

References

1. MarketsandMarkets. (2021). GI Diagnostic Imaging Market by Product, Application, Region—Global Forecast to 2028.
2. U.S. Food and Drug Administration. (2022). Hyaluronic Contrast Media approvals and safety updates.
3. European Medicines Agency. (2022). Medical product assessment reports.
4. IQVIA. (2020). Global Contrast Agents Market Data.