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Last Updated: December 22, 2024

TOLAZAMIDE - Generic Drug Details


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What are the generic drug sources for tolazamide and what is the scope of patent protection?

Tolazamide is the generic ingredient in two branded drugs marketed by Barr, Chartwell Rx, Cosette, Duramed Pharms Barr, Interpharm, Natco, Par Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, Watson Labs, and Pharmacia And Upjohn, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tolazamide.

Summary for TOLAZAMIDE
Recent Clinical Trials for TOLAZAMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)

See all TOLAZAMIDE clinical trials

Medical Subject Heading (MeSH) Categories for TOLAZAMIDE

US Patents and Regulatory Information for TOLAZAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Natco TOLAZAMIDE tolazamide TABLET;ORAL 070259-001 Jan 2, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Interpharm TOLAZAMIDE tolazamide TABLET;ORAL 071271-001 Sep 23, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx TOLAZAMIDE tolazamide TABLET;ORAL 071633-001 Dec 9, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Industries TOLAZAMIDE tolazamide TABLET;ORAL 071358-001 Jul 16, 1987 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

TOLAZAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tolazamide (Tolinase)

Introduction to Tolazamide (Tolinase)

Tolazamide, marketed under the brand name Tolinase, is an oral hypoglycemic agent belonging to the sulfonylurea class. It is used to manage blood glucose levels in patients with Type 2 diabetes. The drug works by stimulating insulin secretion from the pancreatic beta cells, making it a valuable treatment option for patients who still produce some insulin[1][3][4].

Market Drivers

Increasing Prevalence of Diabetes

The global market for tolazamide is significantly driven by the rising prevalence of Type 2 diabetes. As the global population adopts more sedentary lifestyles and poor dietary habits, the incidence of diabetes continues to increase, fueling the demand for effective diabetes management drugs like tolazamide[1][4].

Aging Population

The growing aging population is another key driver. Elderly individuals often require medications to control their blood sugar levels, which boosts the market prospects for tolazamide. This demographic shift ensures a steady and increasing demand for diabetes medications[1][4].

Personalized Treatment Approaches

Healthcare providers are increasingly focusing on personalized treatment plans, tailoring medication choices to suit each patient's needs. Tolazamide's established efficacy makes it a valuable option in this context, contributing to its market growth[4].

Advancements in Diabetes Treatment

The pharmaceutical industry's ongoing research and development efforts are driving innovation in diabetes treatment. This includes the development of more convenient dosing options, such as extended-release formulations, which improve patient compliance and further enhance the market for tolazamide[1][4].

Cost-Effectiveness

The affordability of generic tolazamide has made it a popular choice, especially as healthcare systems emphasize cost-effectiveness. The lower cost of generic versions compared to newer, branded medications makes tolazamide an attractive option for both patients and healthcare providers[1][4].

Market Trends

Segment-Wise and Region-Wise Breakup

The global tolazamide market is segmented based on various factors, including region and market segment. The report provides a detailed breakup of the market, highlighting key regions and segments that are driving growth. This segmentation helps in understanding the market's geographical and demographic dynamics[1][4].

Price Analysis

The market is also influenced by the price trends of various feedstocks used in the manufacturing of tolazamide. The report provides a price analysis of these feedstocks, which is crucial for understanding the cost structure and profit margins of the industry[1][4].

Financial Trajectory

Capital Expenditure (CapEx) and Operational Expenditure (OpEx)

Setting up a tolazamide manufacturing plant involves significant capital and operational expenditures. The report provides a detailed analysis of CapEx, including land acquisition, plant layout, machinery, and raw material costs. OpEx includes ongoing costs such as utility requirements, human resources, and packaging and transportation costs[1][4].

Project Economics

The financial analysis of a tolazamide manufacturing plant includes income and expenditure projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, net present value (NPV), and sensitivity analysis. These metrics are essential for investors and stakeholders to make informed decisions about the viability of the project[1][4].

Revenue Projections

The revenue projections for a tolazamide manufacturing plant are influenced by the market demand, pricing strategies, and competition. With the increasing prevalence of diabetes and the growing demand for cost-effective diabetes medications, the revenue potential for tolazamide is significant[1][4].

Profitability Analysis

The profitability of a tolazamide manufacturing plant is determined by factors such as gross profit, gross margin, net profit, and net margin. The report provides a detailed profitability analysis over several years, helping stakeholders understand the financial performance and potential return on investment (ROI)[1][4].

Regulatory and Financial Assistance

Regulatory Procedures and Approvals

The setup of a tolazamide manufacturing plant requires compliance with various regulatory procedures and approvals. The report provides information on the necessary certifications and financial assistance available, which is crucial for navigating the regulatory landscape[1][4].

Impact of Healthcare Policies

Patient Out-of-Pocket Costs

Healthcare policies, such as those related to Medicare Part D in the United States, significantly impact the out-of-pocket costs for patients with Type 2 diabetes. For instance, reaching age 65 can increase patient out-of-pocket costs due to changes in coverage phases, which can affect the utilization and adherence to diabetes medications like tolazamide[2].

Cost-Reducing Initiatives

Initiatives like the $35 limit on insulin costs per month, introduced in January 2023, can reduce patient cost burdens and improve adherence to diabetes medications. Such policies can influence the market dynamics by increasing the utilization of cost-effective medications like tolazamide[2].

Key Takeaways

  • Increasing Demand: The market for tolazamide is driven by the rising prevalence of Type 2 diabetes and the aging population.
  • Personalized Treatment: Healthcare providers' focus on personalized treatment plans enhances the market for tolazamide.
  • Cost-Effectiveness: The affordability of generic tolazamide makes it a popular choice in cost-conscious healthcare systems.
  • Financial Analysis: Detailed financial analysis, including CapEx, OpEx, and revenue projections, is crucial for setting up a successful tolazamide manufacturing plant.
  • Regulatory Compliance: Compliance with regulatory procedures and approvals is essential for the setup and operation of a tolazamide manufacturing plant.

FAQs

What is the primary mechanism of action of tolazamide?

Tolazamide works by stimulating the release of insulin from the pancreatic beta cells, an effect dependent upon functioning beta cells in the pancreatic islets[3].

How does the increasing prevalence of diabetes impact the market for tolazamide?

The rising prevalence of Type 2 diabetes globally fuels the demand for diabetes management drugs like tolazamide, driving market growth[1][4].

What are the key factors influencing the financial trajectory of a tolazamide manufacturing plant?

Key factors include capital and operational expenditures, revenue projections, taxation, depreciation, and regulatory compliance[1][4].

How do healthcare policies affect the market for tolazamide?

Healthcare policies, such as those related to Medicare Part D and cost-reducing initiatives, can influence patient out-of-pocket costs and adherence to diabetes medications, impacting the market dynamics for tolazamide[2].

What is the significance of personalized treatment approaches in the market for tolazamide?

Personalized treatment approaches by healthcare providers make tolazamide a valuable option due to its established efficacy, contributing to its market growth[4].

Sources

  1. IMARC Group: "Tolazamide (Tolinase) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue"
  2. ASHEcon: "Patient out-of-pocket costs for type 2 diabetes medications when reaching age 65"
  3. DrugBank: "Tolazamide: Uses, Interactions, Mechanism of Action"
  4. IMARC Group: "Tolazamide (Tolinase) Manufacturing Plant Project Report 2023: Raw Materials, Investment Opportunities, Cost and Revenue"

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