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Last Updated: December 23, 2024

CYSTOGRAFIN DILUTE Drug Patent Profile


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Which patents cover Cystografin Dilute, and when can generic versions of Cystografin Dilute launch?

Cystografin Dilute is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CYSTOGRAFIN DILUTE is diatrizoate meglumine. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diatrizoate meglumine profile page.

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Summary for CYSTOGRAFIN DILUTE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 32
Patent Applications: 890
What excipients (inactive ingredients) are in CYSTOGRAFIN DILUTE?CYSTOGRAFIN DILUTE excipients list
DailyMed Link:CYSTOGRAFIN DILUTE at DailyMed
Drug patent expirations by year for CYSTOGRAFIN DILUTE
Pharmacology for CYSTOGRAFIN DILUTE

US Patents and Regulatory Information for CYSTOGRAFIN DILUTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco CYSTOGRAFIN DILUTE diatrizoate meglumine SOLUTION;URETHRAL 010040-022 Nov 9, 1982 RX Yes 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

CYSTOGRAFIN DILUTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cystografin Dilute

Introduction

Cystografin Dilute, a radiopaque contrast agent, is used primarily for retrograde cystourethrography, a procedure to visualize the bladder and urethra. Understanding the market dynamics and financial trajectory of this drug involves examining its indications, usage, pricing, and the broader pharmaceutical market context.

Indications and Usage

Cystografin Dilute is specifically indicated for retrograde cystourethrography, a diagnostic procedure that helps in visualizing the urinary bladder and urethra. The drug is administered through a urinary catheter to fill the bladder, allowing for clear X-ray images[4][5].

Market Demand

The demand for Cystografin Dilute is driven by the need for diagnostic imaging in urology. The prevalence of urinary tract disorders and the necessity for accurate diagnoses contribute to a steady demand for this contrast agent. However, the market is relatively niche compared to other pharmaceutical products, as it is specialized for a specific diagnostic procedure.

Pricing and Cost

The pricing of Cystografin Dilute can vary depending on the region and healthcare provider. For example, according to a hospital's standard charges list, Cystografin Dilute 300 mL can be priced around $55[2].

Dosage and Administration Costs

The dosage of Cystografin Dilute ranges from 25 to 300 mL, depending on the patient's age and bladder irritability. The cost of the procedure includes not only the drug itself but also the associated medical services such as catheterization, X-ray imaging, and medical staff fees. These costs can add up, making the overall procedure expensive for patients.

Competitive Landscape

The market for radiopaque contrast agents is competitive, with several other products available for similar diagnostic procedures. However, Cystografin Dilute holds a specific position due to its formulation and indications. The competitive nature of the pharmaceutical industry, as seen in the development of follow-on drugs, suggests that companies are continually seeking to innovate and capture market share[3].

Financial Trajectory

Revenue Streams

The revenue generated by Cystografin Dilute comes from sales to hospitals, clinics, and other healthcare facilities. The drug's pricing, combined with the frequency of its use in diagnostic procedures, contributes to its revenue stream.

Cost Structure

The cost structure includes the manufacturing costs, distribution expenses, and marketing expenditures. Given that Cystografin Dilute is a specialized product, the manufacturing process may involve higher costs due to the need for sterile conditions and specific formulation requirements.

Market Trends

The pharmaceutical market is subject to various trends, including regulatory changes, technological advancements, and shifts in healthcare policies. For Cystografin Dilute, any changes in the regulatory environment or advancements in diagnostic imaging technologies could impact its market dynamics.

Regulatory Considerations

Cystografin Dilute, like other pharmaceutical products, is subject to stringent regulatory requirements. Ensuring compliance with these regulations is crucial for maintaining market presence. For instance, the use of Cystografin Dilute in pregnant women is only recommended if clearly needed, due to the lack of animal reproduction studies[1][4].

Patient Preparation and Safety

The safe and effective use of Cystografin Dilute depends on proper patient preparation, correct technique, and adequate precautions. This includes recommending a laxative the night before and a low residue diet the day before the procedure. Such precautions are essential for optimizing the diagnostic outcomes and minimizing potential side effects[1][4].

Side Effects and Safety Profile

Common side effects of Cystografin Dilute include injection site reactions, cough, changes in taste sensation, and widening of blood vessels. These side effects are generally manageable but must be considered in the overall risk-benefit analysis for patient care[4].

Conclusion

Cystografin Dilute operates within a specialized segment of the pharmaceutical market, driven by the need for accurate diagnostic imaging in urology. Its financial trajectory is influenced by factors such as pricing, usage frequency, and regulatory compliance. While it faces competition from other contrast agents, its specific indications and formulation help it maintain a niche market position.

Key Takeaways

  • Specialized Use: Cystografin Dilute is specifically indicated for retrograde cystourethrography.
  • Pricing: The drug is priced around $55 for a 300 mL dose, with additional costs for associated medical services.
  • Competitive Landscape: The market is competitive, but Cystografin Dilute holds a unique position due to its formulation and indications.
  • Regulatory Compliance: Strict regulatory requirements must be adhered to, including careful patient preparation and safety precautions.
  • Financial Trajectory: Revenue is generated from sales to healthcare facilities, with costs including manufacturing, distribution, and marketing.

FAQs

What is Cystografin Dilute used for?

Cystografin Dilute is used for retrograde cystourethrography, a diagnostic procedure to visualize the bladder and urethra.

How is Cystografin Dilute administered?

Cystografin Dilute is administered through a urinary catheter to fill the bladder, allowing for clear X-ray images.

What are the common side effects of Cystografin Dilute?

Common side effects include injection site reactions, cough, changes in taste sensation, and widening of blood vessels.

Is Cystografin Dilute safe for use in pregnant women?

Cystografin Dilute should be administered to pregnant women only if clearly needed, as its effects on the fetus are not well understood.

How much does Cystografin Dilute cost?

The cost of Cystografin Dilute can vary, but it is priced around $55 for a 300 mL dose, with additional costs for associated medical services.

Sources

  1. RxList: Cystografin (Diatrizoate Meglumine Injection USP, 30%) - RxList
  2. Wayne HealthCare: 2023 STANDARD CHARGES | Wayne HealthCare
  3. PubMed: The economics of follow-on drug research and development - PubMed
  4. MedicineNet: Cystografin (diatrizoate meglumine) for bladder X-ray - MedicineNet
  5. EMPR: CYSTOGRAFIN DILUTE Prescription & Dosage Information - MPR

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