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Last Updated: December 22, 2024

CERULETIDE DIETHYLAMINE - Generic Drug Details


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What are the generic drug sources for ceruletide diethylamine and what is the scope of freedom to operate?

Ceruletide diethylamine is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ceruletide diethylamine.

Summary for CERULETIDE DIETHYLAMINE
Anatomical Therapeutic Chemical (ATC) Classes for CERULETIDE DIETHYLAMINE

US Patents and Regulatory Information for CERULETIDE DIETHYLAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn TYMTRAN ceruletide diethylamine INJECTABLE;INJECTION 018296-001 Approved Prior to Jan 1, 1982 DISCN 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

CERULETIDE DIETHYLAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ceruletide Diethylamine

Introduction

Ceruletide diethylamine, a synthetic peptide known as caerulein or cerulein, is a drug that mimics the natural gastrointestinal peptide hormone cholecystokinin (CCK). It is used in various therapeutic and diagnostic applications, particularly in the treatment of paralytic ileus and as a diagnostic aid in pancreatic malfunction. Here, we will delve into the market dynamics and financial trajectory of this drug.

Therapeutic and Diagnostic Uses

Ceruletide diethylamine is utilized for its stimulatory effects on gastric, biliary, and pancreatic secretion, as well as its action on certain smooth muscles. It is specifically used in the treatment of paralytic ileus and as a diagnostic tool for assessing pancreatic function and bile duct patency[4].

Market Segmentation

The market for ceruletide diethylamine can be segmented based on its therapeutic and diagnostic indications.

Therapeutic Indications

  • Paralytic Ileus: This condition involves the temporary cessation of the normal contractions of the bowel muscles, leading to a buildup of food, fluids, and gas in the intestines. Ceruletide diethylamine helps in stimulating intestinal motility[4].

Diagnostic Indications

  • Pancreatic Malfunction: The drug is used to assess the functionality of the pancreas and to diagnose issues related to pancreatic secretion.
  • Bile Duct Patency: It helps in evaluating the patency of the bile ducts, which is crucial for the proper flow of bile from the liver to the intestines[4].

Competitive Landscape

The pharmaceutical market for gastrointestinal drugs is highly competitive, with various drugs targeting similar indications. However, ceruletide diethylamine stands out due to its specific mechanism of action as a CCKA receptor agonist.

Follow-On Drugs and Market Competition

The development of follow-on drugs, often referred to as "me-too" drugs, has become a significant factor in the pharmaceutical industry. These drugs, while not necessarily breakthroughs, provide additional therapeutic options and can inject price competition into the market. The trend in the pharmaceutical industry shows that the period of marketing exclusivity for breakthrough drugs has decreased over time, allowing for quicker entry of follow-on drugs into the market[3].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any drug. For ceruletide diethylamine, regulatory approvals and the absence of significant side effects have contributed to its market presence.

Approval and Regulation

While specific approval dates for ceruletide diethylamine are not readily available, its use is well-established in various therapeutic and diagnostic contexts. Regulatory bodies such as the FDA have likely scrutinized its safety and efficacy, given its similarity to the natural hormone cholecystokinin[4].

Financial Trajectory

The financial performance of ceruletide diethylamine is influenced by several factors, including its market demand, competition, and regulatory status.

Market Demand

The demand for ceruletide diethylamine is driven by the need for effective treatments for paralytic ileus and diagnostic tools for pancreatic and bile duct issues. Given its specific mechanism of action and established use, the drug maintains a steady market demand.

Pricing and Revenue

The pricing of ceruletide diethylamine is influenced by its production costs, market competition, and the value it brings to patients and healthcare providers. While exact revenue figures are not available, the drug's niche but essential role in gastrointestinal health contributes to its financial stability.

Research and Development

Continuous research and development are crucial for maintaining market relevance. Studies on ceruletide diethylamine, such as its effects on dopamine release and its potential in treating chronic pancreatitis, indicate ongoing interest and investment in this drug[2][5].

Industry Trends and Future Outlook

The pharmaceutical industry is dynamic, with trends and innovations constantly shaping the market.

Increasing Competitiveness

The pharmaceutical market has become increasingly competitive, with shorter periods of marketing exclusivity and more rapid entry of follow-on drugs. This competition can drive innovation and reduce prices, benefiting consumers[3].

Emerging Therapeutic Areas

Ceruletide diethylamine may find new therapeutic applications, such as in the treatment of chronic pancreatitis, which could expand its market potential[2].

Key Takeaways

  • Therapeutic and Diagnostic Uses: Ceruletide diethylamine is used in treating paralytic ileus and as a diagnostic aid for pancreatic and bile duct issues.
  • Market Segmentation: The drug serves both therapeutic and diagnostic markets, with a focus on gastrointestinal health.
  • Competitive Landscape: It operates in a competitive market with follow-on drugs, but its specific mechanism of action maintains its market presence.
  • Regulatory Environment: The drug is well-established and regulated, ensuring its safety and efficacy.
  • Financial Trajectory: Driven by steady market demand, competitive pricing, and ongoing research and development.

FAQs

What is ceruletide diethylamine used for?

Ceruletide diethylamine is used in the treatment of paralytic ileus and as a diagnostic aid in pancreatic malfunction and assessing bile duct patency[4].

How does ceruletide diethylamine work?

It works by stimulating gastric, biliary, and pancreatic secretion, similar to the natural hormone cholecystokinin, and exerting actions on certain smooth muscles[1][4].

Is ceruletide diethylamine a follow-on drug?

While it is not specifically classified as a follow-on drug, it operates in a market where follow-on drugs are common, and its development and approval process would be influenced by similar market dynamics[3].

What are the potential new therapeutic areas for ceruletide diethylamine?

It may have potential in treating chronic pancreatitis, among other emerging therapeutic areas[2].

How does the regulatory environment impact ceruletide diethylamine?

The regulatory environment ensures the drug's safety and efficacy, contributing to its established market presence and ongoing use[4].

Sources

  1. DrugBank Online: Ceruletide diethylamine.
  2. Synapse: Ceruletide Diethylamine - Drug Targets, Indications, Patents.
  3. PubMed: The economics of follow-on drug research and development.
  4. Pharmacompass: CERULETIDE DIETHYLAMINE | Drug Information, Uses, Side Effects.
  5. PubMed: Ceruletide, a cholecystokinin-related peptide, attenuates haloperidol-induced increase in dopamine release from the rat striatum: an in vivo microdialysis study.

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