OMNIPAQUE 350 Drug Patent Profile

Which patents cover Omnipaque 350, and when can generic versions of Omnipaque 350 launch?

Omnipaque 350 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 350 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omnipaque 350

A generic version of OMNIPAQUE 350 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 350

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,201
DailyMed Link:	OMNIPAQUE 350 at DailyMed

Recent Clinical Trials for OMNIPAQUE 350

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

Sponsor	Phase
University of California, San Diego	PHASE2
Breakthrough T1D	PHASE2
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4

See all OMNIPAQUE 350 clinical trials

Pharmacology for OMNIPAQUE 350

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for OMNIPAQUE 350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	020608-003	Oct 24, 1995		RX	No	No

Expired US Patents for OMNIPAQUE 350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985

International Patents for OMNIPAQUE 350

See the table below for patents covering OMNIPAQUE 350 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	523295
Germany	2031724
Netherlands	153083
Sweden	7706792
Japan	S6210209
Germany	2926850
Denmark	150504

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OMNIPAQUE 350

Last updated: July 27, 2025

---

Introduction

OMNIPAQUE 350, a product developed by GE Healthcare, is a contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans. Its composition as an iodinated contrast medium enables enhanced visualization of vascular structures, tissues, and organs. As a critical component in radiology, understanding its market dynamics and financial trajectory reveals pivotal insights into the current pharmaceutical landscape, regulatory influences, and competitive positioning.

---

Market Overview of Contrast Agents

The global contrast agent market, estimated at approximately USD 4.9 billion in 2022 [1], has experienced consistent growth driven by rising diagnostic imaging procedures, technological advancements, and increasing prevalence of chronic diseases requiring imaging. Contrast media are primarily divided into iodinated agents, gadolinium-based agents, and barium sulfate preparations. OMNIPAQUE 350 falls into the iodinated contrast media (ICM) category, which accounts for the largest revenue share due to broad imaging applications.

---

Key Market Drivers

1. Rising Diagnostic Imaging Procedures

   The global increase in CT scan utilization—projected to grow at a CAGR of 5% through 2028—propels demand for iodinated contrast media like OMNIPAQUE 350 [2]. The COVID-19 pandemic further accelerated the reliance on imaging for disease diagnosis and management, temporarily boosting modulus volume.

2. Prevalence of Chronic Diseases

   Increasing incidences of cardiovascular diseases, cancers, and neurological disorders elevate the need for precise imaging, fostering sustained demand for contrast agents.

3. Technological Innovation

   Enhanced imaging technology and the development of low-osmolar, non-ionic contrast agents improve safety profiles, expanding patient eligibility—further supporting product adoption.

4. Expanding Emerging Markets

   Rapid healthcare infrastructure development in Asia-Pacific, Latin America, and Africa fuels long-term growth potential, with these regions forecasted to grow at a CAGR of 7-8% [3].

---

Market Challenges

1. Regulatory and Safety Considerations

   Risks associated with iodinated contrast agents—such as allergic reactions and nephrotoxicity—prompt stringent regulations and limit usage among vulnerable populations. Recent concerns over gadolinium deposits do not directly impact OMNIPAQUE but influence overall iodinated contrast safety perceptions.

2. Competition and Patent Landscape

   The presence of multiple branded and generic contrast agents intensifies price competition. Recently, patent expirations on certain formulations have introduced generics, potentially reducing revenue margins for OMNIPAQUE.

3. Environmental Concerns

   The ecological impact of contrast media disposal has prompted regulatory scrutiny, possibly leading to production and disposal cost increases.

---

Competitive Landscape

GE Healthcare’s OMNIPAQUE 350 maintains a leading position due to its trusted safety profile and proven efficacy. However, competitors such as Bayer’s Visipaque (iodixanol) and Bracco’s Licomir pose substantial threats, especially as they offer low-osmolar, iso-osmolar, and high-viscosity alternatives, appealing to clinicians prioritizing patient safety.

Moreover, generic versions following patent expiry contribute to price competition, pressuring revenue streams. The challenge remains for GE to innovate through formulations that offer improved safety, reduced side effects, or cost-effective manufacturing to sustain market share.

---

Regulatory Environment

Regulatory authorities like the FDA and EMA impose stringent requirements for contrast media approval, focusing on safety and efficacy. Recent regulations emphasize non-ionic, low-osmolar formulations, which favor products like OMNIPAQUE 350. The ongoing review of adverse effect monitoring and environmental impact could influence future formulation and distribution strategies.

The introduction and approval of new imaging modalities, such as dual-energy CT and molecular imaging, may require contrast agents with specific properties. Thus, adaptability through regulatory compliance will remain crucial.

---

Financial Trajectory Analysis

Historical Performance

GE Healthcare’s contrast media division reported revenues of approximately USD 1 billion in 2021, with iodinated contrast agents contributing a significant portion [4]. OMNIPAQUE 350, being a flagship iodinated contrast product, has historically demonstrated steady sales owing to its broad clinical utility.

Projection of Future Revenues

Forecasting indicates that OMNIPAQUE's revenues will grow at a CAGR of 4-6% over the next five years, aligned with overall growth in diagnostic imaging procedures [2]. The potential impact of patent expirations in the coming 2-3 years necessitates strategic pivots, such as diversification into new formulations or indications, to sustain revenue.

Margins and Pricing Trends

The contrast media market faces downward pressure on pricing owing to generic competition and cost containment initiatives within healthcare systems. Gross margins are expected to contract slightly, emphasizing the importance of operational efficiencies and value-added services to preserve profitability.

Impact of Innovation

Development efforts towards safer, eco-friendly contrast agents and personalized dosing could unlock premium pricing and expanded markets. Investment in research and development (R&D) remains vital for maintaining a technological edge and market relevance.

---

Strategic Outlook

To optimize its financial trajectory, GE Healthcare must navigate regulatory developments, foster innovation, and expand into emerging markets. Partnerships with healthcare providers and investments in new imaging technologies can increase utilization rates of OMNIPAQUE 350. Additionally, portfolio diversification by introducing alternative contrast agents tailored to specific patient groups could mitigate risks associated with patent cliffs and safety concerns.

---

Conclusion

The market dynamics surrounding OMNIPAQUE 350 are shaped by escalating diagnostic imaging demand, technological innovation, and competitive pressures. While the outlook remains positive, especially with the rising global prevalence of chronic diseases and expanding emerging markets, challenges such as regulatory scrutiny, safety considerations, and pricing pressures necessitate strategic agility. Financially, the product is expected to maintain moderate growth, contingent on innovation, regional expansion, and adaptation to evolving clinical needs.

---

Key Takeaways

• Demand drivers—increased use of CT imaging and aging populations—support steady growth for OMNIPAQUE 350.
• Competitive landscape hinges on patent status, safety profiles, and emerging generic options, requiring continuous innovation.
• Regulatory environment influences formulation safety standards and environmental practices, affecting costs and product offerings.
• Emerging markets present substantial growth opportunities, especially in the Asia-Pacific region.
• Financial strategies should emphasize operational efficiencies, diversification, and R&D investment to sustain revenues and margins.

---

FAQs

1. What are the primary indications for OMNIPAQUE 350?
   OMNIPAQUE 350 is used predominantly in computed tomography (CT) imaging to enhance visualization of blood vessels, tissues, and organs, assisting in diagnosing conditions such as tumors, vascular diseases, and inflammatory processes.

2. How does OMNIPAQUE 350 compare safety-wise to other contrast agents?
   OMNIPAQUE 350, as a non-ionic, low-osmolar contrast agent, has a favorable safety profile but still carries risks of allergic reactions and nephrotoxicity in susceptible populations. Ongoing safety improvements aim to minimize side effects.

3. What impact will generic competition have on OMNIPAQUE’s financial performance?
   Patent expirations have introduced generics into the market, exerting downward pressure on prices and margins. Strategic innovation and market expansion are necessary to offset these effects.

4. Are there regulatory challenges that could affect OMNIPAQUE 350’s market?
   Yes, increased scrutiny over safety and environmental impact could lead to stricter regulations, influencing manufacturing costs, formulation labels, and usage limitations.

5. What future developments could influence OMNIPAQUE 350's market?
   Innovations in imaging technology, development of targeted contrast agents, and growing adoption in emerging markets are anticipated to shape its future market trajectory.

---

References

[1] Transparency Market Research, “Contrast Media Market,” 2022.

[2] MarketsandMarkets, “Diagnostic Imaging Market,” 2022.

[3] Grand View Research, “Emerging Opportunities in Contrast Media,” 2022.

[4] GE Healthcare Annual Report, 2021.