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Last Updated: December 22, 2024

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM Drug Patent Profile


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Which patents cover Diatrizoate Meglumine And Diatrizoate Sodium, and when can generic versions of Diatrizoate Meglumine And Diatrizoate Sodium launch?

Diatrizoate Meglumine And Diatrizoate Sodium is a drug marketed by Anda Repository and Annora Pharma and is included in two NDAs.

The generic ingredient in DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 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 Diatrizoate Meglumine And Diatrizoate Sodium

A generic version of DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM was approved as diatrizoate meglumine; diatrizoate sodium by ANDA REPOSITORY on June 27th, 2022.

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Summary for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Drug patent expirations by year for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Pharmacology for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

US Patents and Regulatory Information for DIATRIZOATE MEGLUMINE AND 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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Annora Pharma DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 215049-001 Nov 17, 2023 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DIATRIZOATE MEGLUMINE AND 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 solution is a critical diagnostic tool in the medical field, particularly for radiographic examinations of the gastrointestinal tract. Understanding the market dynamics and financial trajectory of this drug is essential for pharmaceutical companies, investors, and healthcare providers.

Market Demand and Indications

The demand for diatrizoate meglumine and diatrizoate sodium solution is driven by its specific indications for radiographic examinations. It is particularly useful for evaluating the esophagus, stomach, proximal small intestine, and colon, especially when barium sulfate is not feasible or is potentially dangerous[2][3][4].

Competitive Landscape

Camber Pharmaceuticals has recently announced the addition of diatrizoate meglumine and diatrizoate sodium solution to its product line, making it the first and only generic option for Gastrografin®. This move is expected to increase competition in the market, potentially affecting the pricing and market share of branded products[1].

Pricing and Cost Considerations

The pricing of diatrizoate meglumine and diatrizoate sodium solution can be influenced by several factors, including production costs, regulatory approvals, and market competition. Generic options, such as the one introduced by Camber Pharmaceuticals, can lead to lower prices, making the drug more accessible to a wider patient population.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. Diatrizoate meglumine and diatrizoate sodium solution must comply with stringent regulatory standards, including those set by the USP-NF and FDA. Compliance with these regulations can impact the production and distribution costs, thereby affecting the financial trajectory of the drug[5].

Pharmacological and Clinical Benefits

The pharmacological profile of diatrizoate meglumine and diatrizoate sodium, including its high iodine content and water-soluble nature, makes it an effective contrast agent. Its mild laxative effect and minimal absorption from the gastrointestinal tract are additional benefits that contribute to its clinical utility[2][3][4].

Safety and Side Effects

While the drug is generally safe, it carries certain risks such as dehydration, particularly in young or debilitated patients. These safety considerations can influence prescribing patterns and patient compliance, which in turn affect market demand and financial performance[2][3].

Market Segmentation

The market for diatrizoate meglumine and diatrizoate sodium solution can be segmented based on the type of administration (oral or rectal), patient demographics (pediatric, adult, geriatric), and geographical regions. Understanding these segments can help in targeting specific markets and optimizing sales strategies.

Financial Performance

The financial performance of diatrizoate meglumine and diatrizoate sodium solution is tied to its sales volume, pricing, and production costs. With the introduction of generic options, there may be a shift in market share and revenue distribution among manufacturers. Here are some key financial metrics to consider:

  • Revenue Growth: The introduction of generic versions can lead to increased market penetration and revenue growth due to lower prices.
  • Market Share: Camber Pharmaceuticals' entry into the market with a generic option could alter the market share dynamics, potentially reducing the market share of branded products.
  • Cost Structure: Production costs, including the cost of raw materials and manufacturing, will influence the profitability of the drug.
  • Profit Margins: The profit margins for diatrizoate meglumine and diatrizoate sodium solution will be affected by the competitive landscape, pricing strategies, and regulatory compliance costs.

Future Outlook

The future outlook for diatrizoate meglumine and diatrizoate sodium solution is promising due to its essential role in diagnostic imaging. Here are some key trends and predictions:

  • Increased Accessibility: Generic options will make the drug more accessible to a broader patient population, potentially increasing overall sales.
  • Technological Advancements: Advances in imaging technologies may enhance the utility of this contrast agent, driving further demand.
  • Regulatory Changes: Any changes in regulatory requirements or guidelines could impact the production and distribution of the drug, affecting its financial trajectory.

Key Takeaways

  • Market Demand: Driven by specific indications for radiographic examinations of the gastrointestinal tract.
  • Competitive Landscape: Entry of generic options like Camber Pharmaceuticals' product will increase competition.
  • Pricing and Cost: Generic options may lead to lower prices and increased accessibility.
  • Regulatory Environment: Compliance with regulatory standards is crucial.
  • Financial Performance: Revenue growth, market share, and profit margins will be influenced by competition, pricing, and production costs.

FAQs

  1. What is the primary use of diatrizoate meglumine and diatrizoate sodium solution?

    • It is used for radiographic examination of segments of the gastrointestinal tract, including the esophagus, stomach, proximal small intestine, and colon[2][3][4].
  2. Who is the first company to introduce a generic version of this drug?

    • Camber Pharmaceuticals is the first company to introduce a generic version of diatrizoate meglumine and diatrizoate sodium solution, making it a generic option for Gastrografin®[1].
  3. What are the potential side effects of this drug?

    • The drug can cause dehydration, particularly in young or debilitated patients, due to its hypertonic nature[2][3].
  4. How is the drug administered?

    • It is administered orally or rectally, depending on the segment of the gastrointestinal tract being examined[2][3][4].
  5. What impact does the introduction of generic versions have on the market?

    • The introduction of generic versions can increase market penetration, reduce prices, and alter market share dynamics among manufacturers[1].

Cited Sources

  1. Camber Pharmaceuticals Announces Addition of Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP to its Product Line - Pharmacy Times
  2. Diatrizoate Meglumine and Diatrizoate Sodium Solution - DailyMed
  3. Diatrizoate Meglumine and Diatrizoate Sodium Solution - Drugs.com
  4. HYPAQUE-76, Diatrizoate Meglumine and Diatrizoate Sodium - DailyMed
  5. Diatrizoate Meglumine and Diatrizoate Sodium Solution - USP-NF

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