DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM - Generic Drug Details

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

Diatrizoate meglumine; diatrizoate sodium is the generic ingredient in eighteen branded drugs marketed by Bayer Hlthcare, Intl Medication, Ge Healthcare, Mallinckrodt, Liebel-flarsheim, Bracco, Anda Repository, and Annora Pharma, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

US Patents:	0
Tradenames:	18
Applicants:	8
NDAs:	15
Finished Product Suppliers / Packagers:	4
DailyMed Link:	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM at DailyMed

Pharmacology for DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

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

US Patents and Regulatory Information for DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anda Repository	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	214201-001	Jun 27, 2022	AA	RX	No	No
Bracco	RENOVIST II	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010040-019	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
Bracco	RENOVIST	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010040-020	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Hlthcare	GASTROVIST	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	087728-001	Sep 23, 1982		DISCN	No	No
Ge Healthcare	HYPAQUE-M,75%	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	010220-003	Approved Prior to Jan 1, 1982		DISCN	No	No

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diatrizoate Meglumine and Diatrizoate Sodium

Introduction

Diatrizoate meglumine and diatrizoate sodium are crucial components of radiographic contrast agents, widely used in medical imaging to visualize the gastrointestinal tract and other body segments. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, healthcare providers, and investors.

Market Demand and Indications

The demand for diatrizoate meglumine and diatrizoate sodium is driven by their specific indications in radiographic examinations. These agents are particularly useful for examining the esophagus, stomach, proximal small intestine, and colon, especially when barium sulfate is not feasible or is potentially dangerous[1][2].

Competitive Landscape

Camber Pharmaceuticals has recently become the first and only generic option for Gastrografin®, a brand name for diatrizoate meglumine and diatrizoate sodium solution. This development is significant as it introduces competition into a market that was previously dominated by branded products[1].

Pricing and Cost Considerations

The financial implications of using diatrizoate meglumine and diatrizoate sodium versus non-ionic contrast agents are a critical factor. Non-ionic contrast agents are generally better tolerated but are more expensive, which has been a barrier to their widespread adoption. The introduction of generic options like Camber Pharmaceuticals' product could potentially disrupt this dynamic by offering a more cost-effective alternative[5].

Usage in Special Populations

The drug's effectiveness and safety in special populations, such as patients with advanced neoplasms, also influence its market dynamics. A retrospective audit showed that diatrizoate meglumine was well tolerated and effective in resolving intestinal obstruction and constipation in these patients, which could expand its market reach[3].

Pharmacokinetics and Excretion

The pharmacokinetics of diatrizoate meglumine and diatrizoate sodium, including their excretion primarily through the kidneys, affect their usage and safety profile. This information is crucial for healthcare providers and can impact the drug's market acceptance and financial performance[4].

Safety and Side Effects

The safety profile of these drugs, including potential side effects such as dehydration, hypovolemia, and hypotension due to their hypertonic nature, is a significant factor in their market dynamics. Proper dilution and monitoring are essential to mitigate these risks, which can influence prescribing habits and patient compliance[2].

Regulatory Environment

Regulatory approvals and guidelines play a vital role in the market dynamics of pharmaceuticals. The recent addition of diatrizoate meglumine and diatrizoate sodium to Camber Pharmaceuticals' product line, for instance, was made possible through regulatory approvals, highlighting the importance of a favorable regulatory environment[1].

Financial Projections

The financial trajectory of diatrizoate meglumine and diatrizoate sodium is expected to be positive, driven by increasing demand for cost-effective diagnostic imaging solutions. The introduction of generic options is likely to increase market penetration and reduce costs for healthcare providers, which could lead to higher sales volumes.

Impact of Generic Competition

Generic competition, as seen with Camber Pharmaceuticals' entry into the market, can significantly impact the financial trajectory of branded products. Generic options often lead to price reductions, which can increase market share but may also reduce profit margins for branded manufacturers[1].

Research and Development

Continuous research and development are essential for maintaining market relevance. Studies on the effectiveness and safety of diatrizoate meglumine and diatrizoate sodium in various clinical settings, such as their use in patients with advanced neoplasms, help in expanding their indications and improving their market position[3].

Global Market Trends

Global market trends, including the increasing demand for diagnostic imaging due to an aging population and rising healthcare needs, also influence the financial trajectory of these drugs. Emerging markets with growing healthcare infrastructure are likely to contribute significantly to the demand for these contrast agents.

Key Takeaways

• Market Demand: Driven by specific indications in radiographic examinations.
• Competitive Landscape: Introduction of generic options like Camber Pharmaceuticals' product.
• Pricing and Cost: Generic options offer a more cost-effective alternative.
• Usage in Special Populations: Effective in patients with advanced neoplasms.
• Pharmacokinetics and Excretion: Primarily excreted through the kidneys.
• Safety and Side Effects: Potential risks include dehydration and hypovolemia.
• Regulatory Environment: Favorable regulatory approvals are crucial.
• Financial Projections: Positive trajectory driven by increasing demand for cost-effective solutions.

FAQs

1. What are the primary indications for diatrizoate meglumine and diatrizoate sodium?

   • These agents are indicated for radiographic examination of the esophagus, stomach, proximal small intestine, and colon, and as an adjunct to contrast enhancement in computed tomography of the torso[1][2].

2. Who is the first generic manufacturer of diatrizoate meglumine and diatrizoate sodium?

   • Camber Pharmaceuticals is the first and only generic option for Gastrografin®[1].

3. What are the potential side effects of diatrizoate meglumine and diatrizoate sodium?

   • Potential side effects include dehydration, hypovolemia, and hypotension due to their hypertonic nature[2].

4. How are diatrizoate meglumine and diatrizoate sodium excreted from the body?

   • These agents are primarily excreted through the kidneys by glomerular filtration[4].

5. Are diatrizoate meglumine and diatrizoate sodium safe for use in pregnant women?

   • These agents should be used during pregnancy only when clearly needed, as there are no adequate and well-controlled studies in pregnant women[2].

Cited Sources:

1. Camber Pharmaceuticals Announces Addition of Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP. Pharmacy Times.
2. DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM solution. DailyMed.
3. A retrospective audit on usage of Diatrizoate Meglumine .... PubMed.
4. Diatrizoate Meglumine and Diatrizoate Sodium Injection, USP. DailyMed.
5. Meglumine Diatrizoate Plus Sodium Diatrizoate. ScienceDirect.