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Last Updated: December 27, 2024

Cyclizine lactate - Generic Drug Details


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What are the generic sources for cyclizine lactate and what is the scope of patent protection?

Cyclizine lactate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cyclizine lactate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 21
Patent Applications: 935
DailyMed Link:cyclizine lactate at DailyMed
Medical Subject Heading (MeSH) Categories for cyclizine lactate
Anatomical Therapeutic Chemical (ATC) Classes for cyclizine lactate

US Patents and Regulatory Information for cyclizine lactate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline MAREZINE cyclizine lactate INJECTABLE;INJECTION 009495-001 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

Cyclizine lactate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cyclizine Lactate

Introduction

Cyclizine lactate, a histamine H1 antagonist, has been a staple in the treatment of various forms of nausea and vomiting, including motion sickness, postoperative nausea, and vomiting associated with radiotherapy. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Cyclizine lactate was first approved in the 1950s, marking a significant milestone in the management of nausea and vomiting. Its approval in multiple countries, including the United States, has solidified its position in the pharmaceutical market[3].

Therapeutic Indications and Market Demand

The drug is indicated for several key therapeutic areas:

  • Motion Sickness: When the oral route cannot be used, cyclizine lactate is a viable option[5].
  • Postoperative Nausea and Vomiting: Caused by narcotic analgesics and general anaesthetics[2][5].
  • Radiotherapy-Induced Vomiting: Especially in breast cancer patients, as it does not elevate prolactin levels[5].

These indications contribute to a steady demand, particularly in clinical and hospital settings.

Competitive Landscape

The market for antiemetic drugs is competitive, with various other agents available, such as ondansetron and metoclopramide. However, cyclizine lactate's unique profile, particularly its anticholinergic and antihistaminic effects, maintains its relevance. The H1 receptor target presents opportunities for further research and development, potentially expanding its indications[3].

Pharmacoeconomic Considerations

Cyclizine lactate is generally considered cost-effective compared to newer, more expensive antiemetic agents. Its long-standing presence in the market has allowed it to become a preferred choice for many healthcare providers due to its established safety and efficacy profile. This cost-effectiveness contributes to its financial stability and market share.

Sales and Revenue

While exact global sales figures for cyclizine lactate are not readily available, its widespread use and long history suggest a stable revenue stream. The drug is manufactured and distributed by several pharmaceutical companies, contributing to its broad market presence. The revenue is sustained by its use in various clinical settings, including hospitals and outpatient clinics.

Clinical Trials and Research

Cyclizine lactate has undergone rigorous clinical trials to establish its safety and efficacy. Ongoing research, particularly into its potential for treating other conditions related to the H1 receptor, such as urticaria and pruritus, could expand its market potential and financial trajectory[3].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of cyclizine lactate. Approvals and compliance with regulatory standards, such as those set by the Therapeutic Goods Administration (TGA) in Australia and similar bodies in other countries, ensure the drug's continued availability and market stability[1].

Side Effects and Safety Concerns

While cyclizine lactate is generally safe, its side effects, such as dryness of the mouth, constipation, and potential interactions with other anticholinergic drugs, can impact its market dynamics. However, these are well-managed with appropriate dosing and patient monitoring[2][5].

Patient Compliance and Quality of Life

Cyclizine lactate's effectiveness in alleviating nausea and vomiting improves patient quality of life, which in turn can influence market demand positively. Patients who experience relief from symptoms are more likely to adhere to treatment regimens, contributing to the drug's financial stability.

Future Outlook

The future outlook for cyclizine lactate remains positive due to its established therapeutic benefits and ongoing research into new indications. As the pharmaceutical industry continues to evolve, the drug's versatility and cost-effectiveness are likely to maintain its market presence.

Key Takeaways

  • Established Therapeutic Benefits: Cyclizine lactate is well-established in treating nausea and vomiting.
  • Cost-Effectiveness: It is generally more cost-effective than newer antiemetic agents.
  • Regulatory Compliance: Continuous compliance with regulatory standards ensures market stability.
  • Ongoing Research: Potential for new indications could expand its market potential.
  • Patient Compliance: Effective symptom relief improves patient quality of life and treatment adherence.

FAQs

What are the primary indications for cyclizine lactate?

Cyclizine lactate is indicated for the prevention and treatment of nausea and vomiting, including motion sickness, postoperative nausea and vomiting caused by narcotic analgesics and general anaesthetics, and vomiting associated with radiotherapy[2][5].

How does cyclizine lactate work?

Cyclizine lactate works by targeting the H1 receptor, reducing the sensitivity of the labyrinthine apparatus, increasing lower oesophageal sphincter tone, and inhibiting the emetic centre in the midbrain[2][5].

What are the common side effects of cyclizine lactate?

Common side effects include dryness of the mouth, nose, and throat, constipation, increased gastric reflux, and potential interactions with other anticholinergic drugs[2][5].

Is cyclizine lactate safe during pregnancy?

The use of cyclizine lactate in pregnancy is not advised due to the absence of definitive human data[2][5].

How long does the antiemetic effect of cyclizine lactate last?

The antiemetic effect of cyclizine lactate typically lasts approximately four hours after administration[2][5].

Cited Sources:

  1. Australian Public Assessment Report for Cyclizine lactate - Therapeutic Goods Administration.
  2. Cyclizine Lactate, 50 mg/ml solution for injection - Medsafe.
  3. Decoding cyclizine hydrochloride: A Comprehensive Study of its R&D Trends - Synapse Patsnap.
  4. Cyclizine lactate - DrugBank Online.
  5. Cyclizine Lactate 50 mg/ml Solution for Injection - Medicines.org.uk.

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